We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Pharmacokinetic Study of Antiretroviral Drugs and Related Drugs During and After Pregnancy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00042289
Recruitment Status : Completed
First Posted : August 1, 2002
Results First Posted : July 22, 2022
Last Update Posted : July 22, 2022
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Condition HIV Infections
Interventions Drug: atazanavir/cobicistat
Drug: darunavir/ritonavir dosage #1
Drug: darunavir/ritonavir dosage #2
Drug: darunavir/ritonavir dosage #3
Drug: elvitegravir/cobicistat
Drug: dolutegravir
Drug: tenofovir alafenamide fumarate (TAF)
Drug: TAF w/cobicistat
Drug: TAF w/cobicistat or ritonavir
Drug: efavirenz
Drug: darunavir/cobicistat
Drug: lopinavir/ritonavir dosage #1
Drug: atazanavir/ritonavir/tenofovir dosage #1
Drug: rifampicin
Drug: ethambutol
Drug: isoniazid
Drug: pyrazinamide
Drug: kanamycin
Drug: amikacin
Drug: capreomycin
Drug: moxifloxacin
Drug: levoflaxacin
Drug: ofloxacin
Drug: ethionamide/prothionamide
Drug: terizidone/cycloserine
Drug: para-aminosalicylic acid (PAS)
Drug: high dose INH
Drug: bedaquiline
Drug: clofazamine
Drug: delamanid
Drug: linezolid
Drug: pretomanid
Drug: ethinyl estradiol
Drug: etonogestrel implant
Drug: nevirapine
Drug: amprenavir
Drug: abacavir
Drug: lopinavir/ritonavir dosage #2
Drug: indinavir/ritonavir dosage #1
Drug: fosamprenavir/ritonavir
Drug: lopinavir/ritonavir dosage #3
Drug: atazanavir/ritonavir dosage #1
Drug: didanosine delayed release (Videx® EC)
Drug: emtricitabine
Drug: tenofovir
Drug: nelfinavir dosage #1
Drug: tipranavir/ritonavir
Drug: lopinavir/ritonavir dosage #4
Drug: raltegravir
Drug: etravirine
Drug: maraviroc
Drug: atazanavir/ritonavir dosage #2
Drug: tenofovir/atazanavir/ritonavir dosage #2
Drug: nelfinavir dosage #2
Drug: indinavir/ritonavir dosage #2
Drug: rilpivirine
Drug: darunavir/ritonavir dosage #4
Enrollment 1578
Recruitment Details Participants enrolled between 9Jun2003 and 30Dec2019 at US and non-US clinical research sites and could enroll in multiple arms, simultaneously; thus, reporting groups are not mutually exclusive and totals do not reflect the number of unique participants. There were 1578 unique participants (1037 mothers and 541 infants), including 8 mothers enrolled in 3 arms, 36 mothers enrolled in 2 arms, and 24 mother-infant pairs enrolled in 2 arms. Each arm was designed as a separate single-arm evaluation.
Pre-assignment Details  
Arm/Group Title DRV/RTV 600 or 800 or 900/100mg b.i.d. Then 800 or 900/100mg b.i.d. Then 600/100mg b.i.d. DTG 50mg q.d. TAF 25mg q.d. TAF 10mg q.d. w/COBI TAF 25mg q.d. w/COBI or RTV Boosting EVG/COBI 150/150mg q.d. DRV/COBI 800/150 mg q.d. ATV/COBI 300/150 mg q.d. EFV 600 mg q.d. (Outside THA) EFV 600mg q.d. and at Least One 1st Line TB Drug LPV/RTV 800/200mg b.i.d. and at Least One 1st Line TB Drug No ARVs and at Least Two 1st Line TB Drugs At Least Two 2nd Line TB Drugs w/ or w/Out ARVs DRV/COBI 800/150mg q.d. or ATV/COBI 300/150mg q.d With 30-35ug EE DRV/COBI 800/150mg q.d. or ATV/COBI 300/150mg q.d With ENG EFV 600mg q.d. With 30-35ug EE ATV/RTV/TFV 300/100/300mg q.d. With 30-35ug EE NVP 200mg b.i.d ABC 300mg b.i.d LPV/RTV Arm 1: 400/100mg b.i.d IDV/RTV Arm 1: 800/100mg b.i.d FPV/RTV 700/100mg b.i.d. LPV/RTV Arm 2: 400/100mg b.i.d. Then 533/133mg b.i.d. ATV/RTV Arm 1: 300/100mg q.d. DDI 400mg or 250mg q.d. FTC 200mg q.d. TFV 300mg q.d. TFV/ATV/RTV Arm 1: 300/300/100mg q.d. NFV Arm 1: 1250mg b.i.d. EFV 600mg q.d. TPV/RTV 500/200mg b.i.d. LPV/RTV Arm 3: 400/100mg b.i.d. Then 600/150mg b.i.d. Then 400/100mg b.i.d. RAL 400mg b.i.d. ETR 200mg b.i.d. MVC 150 or 300mg b.i.d. DRV/RTV 800/100mg q.d. DRV/RTV 600/100mg b.i.d. ATV/RTV Arm 2: 300/100mg q.d. Then 400/100mg q.d. Then 300/100mg q.d. TFV/ATV/RTV Arm 2: 300/300/100mg q.d. Then 300/400/100mg q.d Then 300/300/100mg q.d. NFV Arm 2: 1250mg b.i.d. Then 1875mg b.i.d. Then 1250mg b.i.d. IDV/RTV Arm 2: 400/100mg q.d. (Only THA) LPV/RTV Arm 4: 400/100mg b.i.d. Then 600/150mg b.i.d. Then 400/100mg b.i.d. (Only African Sites) RPV 25mg q.d. ATV/RTV/TFV 300/100/300mg q.d. With ENG LPV/RTV 400/100 b.i.d. With 30-35ug EE LPV/RTV 400/100 b.i.d. With ENG EFV 600mg q.d. With ENG
Hide Arm/Group Description

HIV-infected pregnant women ≥ 20 weeks gestation NOT on tuberculosis treatment who received:

darunavir/ritonavir twice daily 600/100 mg b.i.d. or 800/100 mg b.i.d. until 30 weeks gestation; then 800/100 mg b.i.d. until postpartum hospital discharge; then 600/100 mg b.i.d. after postpartum hospital discharge until 2 week postpartum PK samples are drawn.

OR darunavir/ritonavir twice daily 600/100 mg b.i.d. or 900/100 mg b.i.d. until 30 weeks gestation; then 900/100 mg b.i.d. until postpartum hospital discharge; then 600/100 mg b.i.d. after postpartum hospital discharge until 2 week postpartum PK samples are drawn.

darunavir/ritonavir dosage #1: darunavir/ritonavir twice daily 600/100 mg b.i.d.

darunavir/ritonavir dosage #2: darunavir/ritonavir twice daily 800/100 mg b.i.d.

darunavir/ritonavir dosage #3: darunavir/ritonavir twice daily 900/100 mg b.i.d.

HIV-infected pregnant women ≥ 20 weeks gestation NOT on tuberculosis treatment who received dolutegravir 50 mg q.d.

dolutegravir: dolutegravir 50 mg q.d.

HIV-infected pregnant women ≥ 20 weeks gestation NOT on tuberculosis treatment who received tenofovir alafenamide fumarate (TAF) 25 mg q.d. without cobicistat or ritonavir boosting.

tenofovir alafenamide fumarate (TAF): TAF 25 mg q.d. without cobicistat or ritonavir boosting

HIV-infected pregnant women ≥ 20 weeks gestation NOT on tuberculosis treatment who received tenofovir alafenamide fumarate (TAF) 10 mg q.d. with cobicistat.

TAF w/cobicistat: TAF 10 mg q.d. with cobicistat

HIV-infected pregnant women ≥ 20 weeks gestation NOT on tuberculosis treatment who received tenofovir alafenamide fumarate (TAF) 25 mg q.d. with cobicistat or ritonavir boosting.

TAF w/cobicistat or ritonavir: TAF 25 mg q.d. with cobicistat or ritonavir boosting

HIV-infected pregnant women ≥ 20 weeks gestation NOT on tuberculosis treatment who received elvitegravir/cobicistat 150/150 mg q.d

elvitegravir/cobicistat: elvitegravir/cobicistat 150/150 mg q.d.

HIV-infected pregnant women ≥ 20 weeks gestation NOT on tuberculosis treatment who received darunavir/cobicistat 800/150 mg q.d.

darunavir/cobicistat: darunavir/cobicistat 800/150 mg q.d.

HIV-infected pregnant women ≥ 20 weeks gestation NOT on tuberculosis treatment who received atazanavir/cobicistat 300/150 mg q.d.

atazanavir/cobicistat: atazanavir/cobicistat 300/150 mg q.d.

HIV-infected pregnant women ≥ 20 weeks gestation NOT on tuberculosis treatment who received efavirenz 600 mg q.d. (Participants outside of Thailand only)

efavirenz: efavirenz 600 mg q.d.

HIV-infected pregnant women ≥ 20 weeks gestation who received efavirenz 600mg q.d.and TB treatment with at least one of the following TB drugs at study entry:

  • rifampicin 8-12 mg/kg (max 600 mg) q.d.; 8-12 mg/kg (max 900 mg) t.i.w.
  • ethambutol 15-20 mg/kg q.d., 25-35 mg/kg t.i.w.
  • isoniazid 4-6 mg/kg (max 300 mg) q.d.; 8-12 mg/kg (max 900 mg) t.i.w.
  • pyrazinamide 20-30mg/kg q.d.; 30-40mg/kg t.i.w.

efavirenz: efavirenz 600 mg q.d.

rifampicin: rifampicin 8-12 mg/kg (max 600 mg) q.d.; 8-12 mg/kg (max 900 mg) t.i.w.

ethambutol: ethambutol 15-20 mg/kg q.d., 25-35 mg/kg t.i.w.

isoniazid: isoniazid 4-6 mg/kg (max 300 mg) q.d.; 8-12 mg/kg (max 900 mg) t.i.w.

pyrazinamide: pyrazinamide 20-30mg/kg q.d.; 30-40mg/kg t.i.w.

HIV-infected pregnant women ≥ 20 weeks gestation who received lopinavir/ritonavir 800/200mg b.i.d. and TB treatment with at least one of the following TB drugs at study entry:

  • rifampicin 8-12 mg/kg (max 600 mg) q.d.; 8-12 mg/kg (max 900 mg) t.i.w.
  • ethambutol 15-20 mg/kg q.d., 25-35 mg/kg t.i.w.
  • isoniazid 4-6 mg/kg (max 300 mg) q.d.; 8-12 mg/kg (max 900 mg) t.i.w.
  • pyrazinamide 20-30mg/kg q.d.; 30-40mg/kg t.i.w.

lopinavir/ritonavir dosage #1: lopinavir/ritonavir 800/200mg b.i.d.

rifampicin: rifampicin 8-12 mg/kg (max 600 mg) q.d.; 8-12 mg/kg (max 900 mg) t.i.w.

ethambutol: ethambutol 15-20 mg/kg q.d., 25-35 mg/kg t.i.w.

isoniazid: isoniazid 4-6 mg/kg (max 300 mg) q.d.; 8-12 mg/kg (max 900 mg) t.i.w.

pyrazinamide: pyrazinamide 20-30mg/kg q.d.; 30-40mg/kg t.i.w.

HIV-uninfected pregnant women ≥ 20 weeks gestation who received at least two of the following first line TB drugs at study entry:

  • rifampicin 8-12 mg/kg (max 600 mg) q.d.; 8-12 mg/kg (max 900 mg) t.i.w.
  • ethambutol 15-20 mg/kg q.d., 25-35 mg/kg t.i.w.
  • isoniazid 4-6 mg/kg (max 300 mg) q.d.; 8-12 mg/kg (max 900 mg) t.i.w.
  • pyrazinamide 20-30mg/kg q.d.; 30-40mg/kg t.i.w.

rifampicin: rifampicin 8-12 mg/kg (max 600 mg) q.d.; 8-12 mg/kg (max 900 mg) t.i.w.

ethambutol: ethambutol 15-20 mg/kg q.d., 25-35 mg/kg t.i.w.

isoniazid: isoniazid 4-6 mg/kg (max 300 mg) q.d.; 8-12 mg/kg (max 900 mg) t.i.w.

pyrazinamide: pyrazinamide 20-30mg/kg q.d.; 30-40mg/kg t.i.w.

HIV-infected and HIV-uninfected pregnant women ≥ 20 weeks gestation who received at least two of the following second line TB drugs at study entry:

Injectable agents:

  • kanamycin
  • amikacin
  • capreomycin

Fluoroquinolones:

  • moxifloxacin
  • levofloxacin
  • ofloxacin

Oral bacteriostatic second-line agents:

  • ethionamide/prothionamide
  • terizidone/cycloserine
  • para-aminosalicylic acid (PAS)

Other agents:

  • high dose INH
  • bedaquiline
  • clofazamine
  • delamanid
  • linezolid
  • pretomanid

kanamycin: kanamycin (2nd line TB drug)

amikacin: amikacin (2nd line TB drug)

capreomycin: capreomycin (2nd line TB drug)

moxifloxacin: moxifloxacin (2nd line TB drug)

levoflaxacin: levofloxacin (2nd line TB drug)

ofloxacin: ofloxacin (2nd line TB drug)

ethionamide/prothionamide: ethionamide/prothionamide (2nd line TB drug)

terizidone/cycloserine: terizidone/cycloserine (2nd line TB drug)

para-aminosalicylic acid (PAS): para-aminosalicylic acid (PAS) (2nd line TB drug)

high dose INH: high dose INH (2nd line TB drug)

bedaquiline: bedaquiline (2nd line TB drug)

clofazamine: clofazamine (2nd TB drug)

delamanid: delamanid (2nd line TB drug)

linezolid: linezolid (2nd line TB drug)

pretomanid: pretomanid (2nd line TB drug)

HIV-infected women 2-12 weeks (14-84 days) post-delivery who received darunavir/cobicistat 800/150 mg q.d. or atazanavir/cobicistat 300/150 mg q.d. postpartum and starting combined oral contraceptives formulated with 30-35 μg ethinyl estradiol

atazanavir/cobicistat: atazanavir/cobicistat 300/150 mg q.d.

darunavir/cobicistat: darunavir/cobicistat 800/150 mg q.d.

ethinyl estradiol: oral contraceptives formulated with 30-35 μg ethinyl estradiol

HIV-infected women 2-12 weeks (14-84 days) post-delivery who received darunavir/cobicistat 800/150 mg q.d. or atazanavir/cobicistat 300/150 mg q.d. postpartum and starting etonogestrel implant

atazanavir/cobicistat: atazanavir/cobicistat 300/150 mg q.d.

darunavir/cobicistat: darunavir/cobicistat 800/150 mg q.d.

etonogestrel implant: etonogestrel implant contraceptive

HIV-infected women 2-12 weeks (14-84 days) post-delivery who received efavirenz 600mg q.d. postpartum and starting combined oral contraceptives formulated with 30-35 μg ethinyl estradiol

efavirenz: efavirenz 600 mg q.d.

ethinyl estradiol: oral contraceptives formulated with 30-35 μg ethinyl estradiol

HIV-infected women 2-12 weeks (14-84 days) post-delivery who received atazanavir/ritonavir/tenofovir 300/100/300 mg q.d. postpartum and starting combined oral contraceptives formulated with 30-35 μg ethinyl estradiol

atazanavir/ritonavir/tenofovir dosage #1: atazanavir/ritonavir/tenofovir 300/100/300mg q.d.

ethinyl estradiol: oral contraceptives formulated with 30-35 μg ethinyl estradiol

HIV-infected pregnant women ≥ 26 weeks gestation who received nevirapine 200 mg twice a day

nevirapine: nevirapine 200 mg twice a day

HIV-infected pregnant women ≥ 20 weeks gestation who received abacavir 300mg twice a day

abacavir: abacavir 300mg twice a day

HIV-infected pregnant women ≥ 26 weeks gestation who received lopinavir/ritonavir (Kaletra) 400/100mg twice a day

lopinavir/ritonavir dosage #2: lopinavir/ritonavir (Kaletra) 400/100mg twice a day

HIV-infected pregnant women ≥ 26 weeks gestation who received indinavir/ritonavir 800/100 mg twice a day

indinavir/ritonavir dosage #1: indinavir/ritonavir 800/100mg twice a day

HIV-infected pregnant women ≥ 20 weeks gestation who received fosamprenavir/ritonavir 700/100mg twice a day

fosamprenavir/ritonavir: fosamprenavir/ritonavir 700/100 mg twice a day

HIV-infected pregnant women ≥ 20 weeks gestation who received Kaletra 400/100 mg twice a day until 30 weeks gestation, then 533/133 mg twice a day until results of postpartum PK evaluation were available

lopinavir/ritonavir dosage #2: lopinavir/ritonavir (Kaletra) 400/100mg twice a day

lopinavir/ritonavir dosage #3: lopinavir/ritonavir (Kaletra) 533/133 mg twice a day

HIV-infected pregnant women ≥ 20 weeks gestation who received atazanavir/ritonavir 300/100 mg once a day

atazanavir/ritonavir dosage #1: atazanavir/ritonavir 300/100 mg once a day

HIV-infected pregnant women ≥ 20 weeks gestation who received didanosine delayed release (Videx® EC) 400 mg once a day if weight > 60 kg; 250 mg once a day if weight < 60 kg

didanosine delayed release (Videx® EC): didanosine delayed release (Videx® EC) 400 mg once a day if weight > 60 kg; 250 mg once a day if weight < 60 kg

HIV-infected pregnant women ≥ 20 weeks gestation who received emtricitabine 200 mg once a day

emtricitabine: emtricitabine 200 mg once a day

HIV-infected pregnant women ≥ 20 weeks gestation who received tenofovir 300 mg once a day

tenofovir: tenofovir 300 mg once a day

HIV-infected pregnant women ≥ 20 weeks gestation who received tenofovir/atazanavir/ritonavir 300/300/100 mg once a day

atazanavir/ritonavir/tenofovir dosage #1: atazanavir/ritonavir/tenofovir 300/100/300mg q.d.

HIV-infected pregnant women ≥ 20 weeks gestation who received nelfinavir [625 mg tablets] 1250 mg twice a day

nelfinavir dosage #1: nelfinavir [625 mg tablets] 1250 mg twice a day

HIV-infected pregnant women ≥ 20 weeks gestation who received efavirenz 600 mg once a day

efavirenz: efavirenz 600 mg q.d.

HIV-infected pregnant women ≥ 20 weeks gestation who received tipranavir/ritonavir 500/200 mg twice a day

tipranavir/ritonavir: tipranavir/ritonavir 500/200 mg twice a day

HIV-infected pregnant women ≥ 20 weeks gestation who received lopinavir/ritonavir (Kaletra) tablets 400/100 mg [2 tablets] twice a day until 30 weeks gestation, then 600/150 mg [3 tablets] twice a day until postpartum hospital discharge; and 400/100 mg [2 tablets] twice a day after postpartum hospital discharge, until 2 week postpartum PK sample is drawn

lopinavir/ritonavir dosage #2: lopinavir/ritonavir (Kaletra) 400/100mg twice a day

lopinavir/ritonavir dosage #4: lopinavir/ritonavir (Kaletra) tablets 600/150 mg [3 tablets] twice a day

HIV-infected pregnant women ≥ 20 weeks gestation who received raltegravir 400 mg twice a day

raltegravir: raltegravir 400 mg twice a day

HIV-infected pregnant women ≥ 20 weeks gestation who received etravirine 200mg twice a day

etravirine: etravirine 200 mg twice a day

HIV-infected pregnant women ≥ 20 weeks gestation who received maraviroc 150 mg or 300 mg twice a day

maraviroc: maraviroc 150 mg or 300 mg twice a day

HIV-infected pregnant women ≥ 20 weeks gestation who received darunavir/ritonavir 800/100 mg once a day

darunavir/ritonavir dosage #4: darunavir/ritonavir once daily 800/100 mg q.d.

HIV-infected pregnant women ≥ 20 weeks gestation who received darunavir/ritonavir 600/100 mg twice a day

darunavir/ritonavir dosage #1: darunavir/ritonavir twice daily 600/100 mg b.i.d.

HIV-infected pregnant women ≥ 20 weeks gestation who received atazanavir/ritonavir 300/100 mg once a day until 30 weeks gestation then 400/100 mg once a day until postpartum hospital discharge; then 300/100 mg once a day after postpartum hospital discharge until 2 week postpartum PK samples drawn

atazanavir/ritonavir dosage #1: atazanavir/ritonavir 300/100 mg once a day

atazanavir/ritonavir dosage #2: atazanavir/ritonavir 400/100mg once a day

HIV-infected pregnant women ≥ 20 weeks gestation who received tenofovir/atazanavir/ritonavir 300/300/100 mg once a day until 30 weeks gestation; then 300/400/100 mg once a day until postpartum hospital discharge; then 300/300/100 mg once a day after postpartum hospital discharge until 2 week postpartum PK samples drawn

atazanavir/ritonavir/tenofovir dosage #1: atazanavir/ritonavir/tenofovir 300/100/300mg q.d.

tenofovir/atazanavir/ritonavir dosage #2: tenofovir/atazanavir/ritonavir 300/400/100 mg once a day

HIV-infected pregnant women ≥ 20 weeks gestation who received nelfinavir [625 mg tablets] 1250 mg twice a day until 30 weeks gestation; then 1875 mg twice a day until postpartum hospital discharge; then 1250 mg twice a day after postpartum hospital discharge until 2 week postpartum PK samples drawn

nelfinavir dosage #1: nelfinavir [625 mg tablets] 1250 mg twice a day

nelfinavir dosage #2: nelfinavir [625 mg tablets] 1875 mg twice a day

HIV-infected pregnant women ≥ 20 weeks gestation who received indinavir/ritonavir 400/100 mg twice a day only to participants enrolling in Thailand

indinavir/ritonavir dosage #2: indinavir/ritonavir 400/100 mg twice a day

HIV-infected pregnant women ≥ 20 weeks gestation who received lopinavir/ritonavir (Alluvia tablets) 400/100 mg [2 tablets] twice day until 30 weeks gestation; then 600/150 mg [3 tablets] twice a day until postpartum hospital discharge; then 400/100 mg [2 tablets] twice a day after postpartum hospital discharge until 2 week postpartum PK sample drawn only to participants enrolling in Uganda

lopinavir/ritonavir dosage #2: lopinavir/ritonavir (Kaletra) 400/100mg twice a day

lopinavir/ritonavir dosage #4: lopinavir/ritonavir (Kaletra) tablets 600/150 mg [3 tablets] twice a day

HIV-infected pregnant women ≥ 20 weeks gestation who received rilpivirine (25 mg q.d.)

rilpivirine: rilpivirine (25 mg q.d.)

HIV- infected women 2-12 weeks postpartum who received atazanavir/ritonavir/tenofovir 300/100/300 mg q.d. postpartum and starting postpartum etonogestrel implant

atazanavir/ritonavir/tenofovir dosage #1: atazanavir/ritonavir/tenofovir 300/100/300mg q.d.

etonogestrel implant: etonogestrel implant contraceptive

HIV- infected women 2-12 weeks postpartum who received lopinavir/ritonavir 400/100 b.i.d. postpartum and starting combined oral contraceptives formulated with 30-35 μg ethinyl estradiol

ethinyl estradiol: oral contraceptives formulated with 30-35 μg ethinyl estradiol

lopinavir/ritonavir dosage #2: lopinavir/ritonavir (Kaletra) 400/100mg twice a day

HIV- infected women 2-12 weeks postpartum who received lopinavir/ritonavir 400/100 b.i.d. postpartum and starting postpartum etonogestrel implant

etonogestrel implant: etonogestrel implant contraceptive

lopinavir/ritonavir dosage #2: lopinavir/ritonavir (Kaletra) 400/100mg twice a day

HIV-infected women 2-12 weeks postpartum who received efavirenz 600mg q.d. postpartum and starting postpartum etonogestrel implant

efavirenz: efavirenz 600 mg q.d.

etonogestrel implant: etonogestrel implant contraceptive

Period Title: Overall Study
Started 26 30 27 33 29 31 28 12 27 24 2 27 13 2 6 29 28 12 26 17 1 30 29 22 18 21 28 25 29 25 1 35 43 16 12 32 36 38 35 18 26 25 32 25 27 27 28
Infant Started 25 30 27 32 28 31 27 12 26 23 2 27 14 0 0 0 0 0 0 0 0 9 0 22 4 5 0 21 0 21 0 0 6 6 4 0 9 38 35 0 26 25 30 0 0 0 0
Infant Completed 21 28 27 29 26 25 26 10 25 20 2 24 11 0 0 0 0 0 0 0 0 9 0 20 3 5 0 20 0 21 0 0 6 4 4 0 8 35 34 0 26 21 27 0 0 0 0
Completed 19 29 27 25 26 25 22 10 26 23 2 27 11 2 6 28 27 12 18 13 1 26 27 17 17 20 20 22 21 25 0 26 38 10 10 27 32 36 33 13 26 22 25 22 27 26 27
Not Completed 7 1 0 8 3 6 6 2 1 1 0 0 2 0 0 1 1 0 8 4 0 4 2 5 1 1 8 3 8 0 1 9 5 6 2 5 4 2 2 5 0 3 7 3 0 1 1
Reason Not Completed
Lost to Follow-up             3             0             0             1             3             3             6             1             1             0             0             0             0             0             0             1             1             0             3             2             0             0             0             0             0             0             2             2             2             0             0             2             1             1             1             2             1             1             0             5             0             2             2             0             0             1             0
Other reason             0             0             0             2             0             0             0             0             0             0             0             0             0             0             0             0             0             0             1             0             0             0             0             1             0             0             1             0             3             0             0             1             0             1             0             2             0             0             0             0             0             0             0             1             0             0             0
Severe debilitation, unable to continue             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             1             0             1             0             0             0             1             0             0             0             1             1             0             0             0             0             0             0             0             0             0             0             0             0             0             0
Site closed             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             3             0             0             0             0             1             0             0             0             0             0             1             0             0             0             0
Participant not willing to adhere to requirements             0             0             0             3             0             0             0             0             0             0             0             0             0             0             0             0             0             0             4             2             0             2             1             1             0             1             2             0             1             0             0             1             1             3             1             1             2             0             2             0             0             0             2             1             0             0             1
Protocol Violation             0             0             0             0             0             1             0             1             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             1             1             0             2             0             0             0             1             0             0             0             0             0             0             0             0             0             0             1             1             1             0             0             0
Withdrawal by Subject             4             1             0             2             0             2             0             0             0             1             0             0             2             0             0             0             0             0             0             0             0             1             1             1             0             0             1             0             2             0             0             1             2             1             0             0             0             1             0             0             0             0             1             0             0             0             0
Arm/Group Title DRV/RTV 600 or 800 or 900/100mg b.i.d. Then 800 or 900/100mg b.i.d. Then 600/100mg b.i.d. DTG 50mg q.d. TAF 25mg q.d. TAF 10mg q.d. w/COBI TAF 25mg q.d. w/COBI or RTV Boosting EVG/COBI 150/150mg q.d. DRV/COBI 800/150 mg q.d. ATV/COBI 300/150 mg q.d. EFV 600 mg q.d. (Outside THA) EFV 600mg q.d. and at Least One 1st Line TB Drug LPV/RTV 800/200mg b.i.d. and at Least One 1st Line TB Drug No ARVs and at Least Two 1st Line TB Drugs At Least Two 2nd Line TB Drugs w/ or w/Out ARVs DRV/COBI 800/150mg q.d. or ATV/COBI 300/150mg q.d With 30-35ug EE DRV/COBI 800/150mg q.d. or ATV/COBI 300/150mg q.d With ENG EFV 600mg q.d. With 30-35ug EE ATV/RTV/TFV 300/100/300mg q.d. With 30-35ug EE NVP 200mg b.i.d ABC 300mg b.i.d LPV/RTV Arm 1: 400/100mg b.i.d IDV/RTV Arm 1: 800/100mg b.i.d FPV/RTV 700/100mg b.i.d. LPV/RTV Arm 2: 400/100mg b.i.d. Then 533/133mg b.i.d. ATV/RTV Arm 1: 300/100mg q.d. DDI 400mg or 250mg q.d. FTC 200mg q.d. TFV 300mg q.d. TFV/ATV/RTV Arm 1: 300/300/100mg q.d. NFV Arm 1: 1250mg b.i.d. EFV 600mg q.d. TPV/RTV 500/200mg b.i.d. LPV/RTV Arm 3: 400/100mg b.i.d. Then 600/150mg b.i.d. Then 400/100mg b.i.d. RAL 400mg b.i.d. ETR 200mg b.i.d. MVC 150 or 300mg b.i.d. DRV/RTV 800/100mg q.d. DRV/RTV 600/100mg b.i.d. ATV/RTV Arm 2: 300/100mg q.d. Then 400/100mg q.d. Then 300/100mg q.d. TFV/ATV/RTV Arm 2: 300/300/100mg q.d. Then 300/400/100mg q.d Then 300/300/100mg q.d. NFV Arm 2: 1250mg b.i.d. Then 1875mg b.i.d. Then 1250mg b.i.d. IDV/RTV Arm 2: 400/100mg q.d. (Only THA) LPV/RTV Arm 4: 400/100mg b.i.d. Then 600/150mg b.i.d. Then 400/100mg b.i.d. (Only African Sites) RPV 25mg q.d. ATV/RTV/TFV 300/100/300mg q.d. With ENG LPV/RTV 400/100 b.i.d. With 30-35ug EE LPV/RTV 400/100 b.i.d. With ENG EFV 600mg q.d. With ENG Total
Hide Arm/Group Description

HIV-infected pregnant women ≥ 20 weeks gestation NOT on tuberculosis treatment who received:

darunavir/ritonavir twice daily 600/100 mg b.i.d. or 800/100 mg b.i.d. until 30 weeks gestation; then 800/100 mg b.i.d. until postpartum hospital discharge; then 600/100 mg b.i.d. after postpartum hospital discharge until 2 week postpartum PK samples are drawn.

OR darunavir/ritonavir twice daily 600/100 mg b.i.d. or 900/100 mg b.i.d. until 30 weeks gestation; then 900/100 mg b.i.d. until postpartum hospital discharge; then 600/100 mg b.i.d. after postpartum hospital discharge until 2 week postpartum PK samples are drawn.

darunavir/ritonavir dosage #1: darunavir/ritonavir twice daily 600/100 mg b.i.d.

darunavir/ritonavir dosage #2: darunavir/ritonavir twice daily 800/100 mg b.i.d.

darunavir/ritonavir dosage #3: darunavir/ritonavir twice daily 900/100 mg b.i.d.

HIV-infected pregnant women ≥ 20 weeks gestation NOT on tuberculosis treatment who received dolutegravir 50 mg q.d.

dolutegravir: dolutegravir 50 mg q.d.

HIV-infected pregnant women ≥ 20 weeks gestation NOT on tuberculosis treatment who received tenofovir alafenamide fumarate (TAF) 25 mg q.d. without cobicistat or ritonavir boosting.

tenofovir alafenamide fumarate (TAF): TAF 25 mg q.d. without cobicistat or ritonavir boosting

HIV-infected pregnant women ≥ 20 weeks gestation NOT on tuberculosis treatment who received tenofovir alafenamide fumarate (TAF) 10 mg q.d. with cobicistat.

TAF w/cobicistat: TAF 10 mg q.d. with cobicistat

HIV-infected pregnant women ≥ 20 weeks gestation NOT on tuberculosis treatment who received tenofovir alafenamide fumarate (TAF) 25 mg q.d. with cobicistat or ritonavir boosting.

TAF w/cobicistat or ritonavir: TAF 25 mg q.d. with cobicistat or ritonavir boosting

HIV-infected pregnant women ≥ 20 weeks gestation NOT on tuberculosis treatment who received elvitegravir/cobicistat 150/150 mg q.d

elvitegravir/cobicistat: elvitegravir/cobicistat 150/150 mg q.d.

HIV-infected pregnant women ≥ 20 weeks gestation NOT on tuberculosis treatment who received darunavir/cobicistat 800/150 mg q.d.

darunavir/cobicistat: darunavir/cobicistat 800/150 mg q.d.

HIV-infected pregnant women ≥ 20 weeks gestation NOT on tuberculosis treatment who received atazanavir/cobicistat 300/150 mg q.d.

atazanavir/cobicistat: atazanavir/cobicistat 300/150 mg q.d.

HIV-infected pregnant women ≥ 20 weeks gestation NOT on tuberculosis treatment who received efavirenz 600 mg q.d. (Participants outside of Thailand only)

efavirenz: efavirenz 600 mg q.d.

HIV-infected pregnant women ≥ 20 weeks gestation who received efavirenz 600mg q.d.and TB treatment with at least one of the following TB drugs at study entry:

  • rifampicin 8-12 mg/kg (max 600 mg) q.d.; 8-12 mg/kg (max 900 mg) t.i.w.
  • ethambutol 15-20 mg/kg q.d., 25-35 mg/kg t.i.w.
  • isoniazid 4-6 mg/kg (max 300 mg) q.d.; 8-12 mg/kg (max 900 mg) t.i.w.
  • pyrazinamide 20-30mg/kg q.d.; 30-40mg/kg t.i.w.

efavirenz: efavirenz 600 mg q.d.

rifampicin: rifampicin 8-12 mg/kg (max 600 mg) q.d.; 8-12 mg/kg (max 900 mg) t.i.w.

ethambutol: ethambutol 15-20 mg/kg q.d., 25-35 mg/kg t.i.w.

isoniazid: isoniazid 4-6 mg/kg (max 300 mg) q.d.; 8-12 mg/kg (max 900 mg) t.i.w.

pyrazinamide: pyrazinamide 20-30mg/kg q.d.; 30-40mg/kg t.i.w.

HIV-infected pregnant women ≥ 20 weeks gestation who received lopinavir/ritonavir 800/200mg b.i.d. and TB treatment with at least one of the following TB drugs at study entry:

  • rifampicin 8-12 mg/kg (max 600 mg) q.d.; 8-12 mg/kg (max 900 mg) t.i.w.
  • ethambutol 15-20 mg/kg q.d., 25-35 mg/kg t.i.w.
  • isoniazid 4-6 mg/kg (max 300 mg) q.d.; 8-12 mg/kg (max 900 mg) t.i.w.
  • pyrazinamide 20-30mg/kg q.d.; 30-40mg/kg t.i.w.

lopinavir/ritonavir dosage #1: lopinavir/ritonavir 800/200mg b.i.d.

rifampicin: rifampicin 8-12 mg/kg (max 600 mg) q.d.; 8-12 mg/kg (max 900 mg) t.i.w.

ethambutol: ethambutol 15-20 mg/kg q.d., 25-35 mg/kg t.i.w.

isoniazid: isoniazid 4-6 mg/kg (max 300 mg) q.d.; 8-12 mg/kg (max 900 mg) t.i.w.

pyrazinamide: pyrazinamide 20-30mg/kg q.d.; 30-40mg/kg t.i.w.

HIV-uninfected pregnant women ≥ 20 weeks gestation who received at least two of the following first line TB drugs at study entry:

  • rifampicin 8-12 mg/kg (max 600 mg) q.d.; 8-12 mg/kg (max 900 mg) t.i.w.
  • ethambutol 15-20 mg/kg q.d., 25-35 mg/kg t.i.w.
  • isoniazid 4-6 mg/kg (max 300 mg) q.d.; 8-12 mg/kg (max 900 mg) t.i.w.
  • pyrazinamide 20-30mg/kg q.d.; 30-40mg/kg t.i.w.

rifampicin: rifampicin 8-12 mg/kg (max 600 mg) q.d.; 8-12 mg/kg (max 900 mg) t.i.w.

ethambutol: ethambutol 15-20 mg/kg q.d., 25-35 mg/kg t.i.w.

isoniazid: isoniazid 4-6 mg/kg (max 300 mg) q.d.; 8-12 mg/kg (max 900 mg) t.i.w.

pyrazinamide: pyrazinamide 20-30mg/kg q.d.; 30-40mg/kg t.i.w.

HIV-infected and HIV-uninfected pregnant women ≥ 20 weeks gestation who received at least two of the following second line TB drugs at study entry:

Injectable agents:

  • kanamycin
  • amikacin
  • capreomycin

Fluoroquinolones:

  • moxifloxacin
  • levofloxacin
  • ofloxacin

Oral bacteriostatic second-line agents:

  • ethionamide/prothionamide
  • terizidone/cycloserine
  • para-aminosalicylic acid (PAS)

Other agents:

  • high dose INH
  • bedaquiline
  • clofazamine
  • delamanid
  • linezolid
  • pretomanid

kanamycin: kanamycin (2nd line TB drug)

amikacin: amikacin (2nd line TB drug)

capreomycin: capreomycin (2nd line TB drug)

moxifloxacin: moxifloxacin (2nd line TB drug)

levoflaxacin: levofloxacin (2nd line TB drug)

ofloxacin: ofloxacin (2nd line TB drug)

ethionamide/prothionamide: ethionamide/prothionamide (2nd line TB drug)

terizidone/cycloserine: terizidone/cycloserine (2nd line TB drug)

para-aminosalicylic acid (PAS): para-aminosalicylic acid (PAS) (2nd line TB drug)

high dose INH: high dose INH (2nd line TB drug)

bedaquiline: bedaquiline (2nd line TB drug)

clofazamine: clofazamine (2nd TB drug)

delamanid: delamanid (2nd line TB drug)

linezolid: linezolid (2nd line TB drug)

pretomanid: pretomanid (2nd line TB drug)

HIV-infected women 2-12 weeks (14-84 days) post-delivery who received darunavir/cobicistat 800/150 mg q.d. or atazanavir/cobicistat 300/150 mg q.d. postpartum and starting combined oral contraceptives formulated with 30-35 μg ethinyl estradiol

atazanavir/cobicistat: atazanavir/cobicistat 300/150 mg q.d.

darunavir/cobicistat: darunavir/cobicistat 800/150 mg q.d.

ethinyl estradiol: oral contraceptives formulated with 30-35 μg ethinyl estradiol

HIV-infected women 2-12 weeks (14-84 days) post-delivery who received darunavir/cobicistat 800/150 mg q.d. or atazanavir/cobicistat 300/150 mg q.d. postpartum and starting etonogestrel implant

atazanavir/cobicistat: atazanavir/cobicistat 300/150 mg q.d.

darunavir/cobicistat: darunavir/cobicistat 800/150 mg q.d.

etonogestrel implant: etonogestrel implant contraceptive

HIV-infected women 2-12 weeks (14-84 days) post-delivery who received efavirenz 600mg q.d. postpartum and starting combined oral contraceptives formulated with 30-35 μg ethinyl estradiol

efavirenz: efavirenz 600 mg q.d.

ethinyl estradiol: oral contraceptives formulated with 30-35 μg ethinyl estradiol

HIV-infected women 2-12 weeks (14-84 days) post-delivery who received atazanavir/ritonavir/tenofovir 300/100/300 mg q.d. postpartum and starting combined oral contraceptives formulated with 30-35 μg ethinyl estradiol

atazanavir/ritonavir/tenofovir dosage #1: atazanavir/ritonavir/tenofovir 300/100/300mg q.d.

ethinyl estradiol: oral contraceptives formulated with 30-35 μg ethinyl estradiol

HIV-infected pregnant women ≥ 26 weeks gestation who received nevirapine 200 mg twice a day

nevirapine: nevirapine 200 mg twice a day

HIV-infected pregnant women ≥ 20 weeks gestation who received abacavir 300mg twice a day

abacavir: abacavir 300mg twice a day

HIV-infected pregnant women ≥ 26 weeks gestation who received lopinavir/ritonavir (Kaletra) 400/100mg twice a day

lopinavir/ritonavir dosage #2: lopinavir/ritonavir (Kaletra) 400/100mg twice a day

HIV-infected pregnant women ≥ 26 weeks gestation who received indinavir/ritonavir 800/100 mg twice a day

indinavir/ritonavir dosage #1: indinavir/ritonavir 800/100mg twice a day

HIV-infected pregnant women ≥ 20 weeks gestation who received fosamprenavir/ritonavir 700/100mg twice a day

fosamprenavir/ritonavir: fosamprenavir/ritonavir 700/100 mg twice a day

HIV-infected pregnant women ≥ 20 weeks gestation who received Kaletra 400/100 mg twice a day until 30 weeks gestation, then 533/133 mg twice a day until results of postpartum PK evaluation were available

lopinavir/ritonavir dosage #2: lopinavir/ritonavir (Kaletra) 400/100mg twice a day

lopinavir/ritonavir dosage #3: lopinavir/ritonavir (Kaletra) 533/133 mg twice a day

HIV-infected pregnant women ≥ 20 weeks gestation who received atazanavir/ritonavir 300/100 mg once a day

atazanavir/ritonavir dosage #1: atazanavir/ritonavir 300/100 mg once a day

HIV-infected pregnant women ≥ 20 weeks gestation who received didanosine delayed release (Videx® EC) 400 mg once a day if weight > 60 kg; 250 mg once a day if weight < 60 kg

didanosine delayed release (Videx® EC): didanosine delayed release (Videx® EC) 400 mg once a day if weight > 60 kg; 250 mg once a day if weight < 60 kg

HIV-infected pregnant women ≥ 20 weeks gestation who received emtricitabine 200 mg once a day

emtricitabine: emtricitabine 200 mg once a day

HIV-infected pregnant women ≥ 20 weeks gestation who received tenofovir 300 mg once a day

tenofovir: tenofovir 300 mg once a day

HIV-infected pregnant women ≥ 20 weeks gestation who received tenofovir/atazanavir/ritonavir 300/300/100 mg once a day

atazanavir/ritonavir/tenofovir dosage #1: atazanavir/ritonavir/tenofovir 300/100/300mg q.d.

HIV-infected pregnant women ≥ 20 weeks gestation who received nelfinavir [625 mg tablets] 1250 mg twice a day

nelfinavir dosage #1: nelfinavir [625 mg tablets] 1250 mg twice a day

HIV-infected pregnant women ≥ 20 weeks gestation who received efavirenz 600 mg once a day

efavirenz: efavirenz 600 mg q.d.

HIV-infected pregnant women ≥ 20 weeks gestation who received tipranavir/ritonavir 500/200 mg twice a day

tipranavir/ritonavir: tipranavir/ritonavir 500/200 mg twice a day

HIV-infected pregnant women ≥ 20 weeks gestation who received lopinavir/ritonavir (Kaletra) tablets 400/100 mg [2 tablets] twice a day until 30 weeks gestation, then 600/150 mg [3 tablets] twice a day until postpartum hospital discharge; and 400/100 mg [2 tablets] twice a day after postpartum hospital discharge, until 2 week postpartum PK sample is drawn

lopinavir/ritonavir dosage #2: lopinavir/ritonavir (Kaletra) 400/100mg twice a day

lopinavir/ritonavir dosage #4: lopinavir/ritonavir (Kaletra) tablets 600/150 mg [3 tablets] twice a day

HIV-infected pregnant women ≥ 20 weeks gestation who received raltegravir 400 mg twice a day

raltegravir: raltegravir 400 mg twice a day

HIV-infected pregnant women ≥ 20 weeks gestation who received etravirine 200mg twice a day

etravirine: etravirine 200 mg twice a day

HIV-infected pregnant women ≥ 20 weeks gestation who received maraviroc 150 mg or 300 mg twice a day

maraviroc: maraviroc 150 mg or 300 mg twice a day

HIV-infected pregnant women ≥ 20 weeks gestation who received darunavir/ritonavir 800/100 mg once a day

darunavir/ritonavir dosage #4: darunavir/ritonavir once daily 800/100 mg q.d.

HIV-infected pregnant women ≥ 20 weeks gestation who received darunavir/ritonavir 600/100 mg twice a day

darunavir/ritonavir dosage #1: darunavir/ritonavir twice daily 600/100 mg b.i.d.

HIV-infected pregnant women ≥ 20 weeks gestation who received atazanavir/ritonavir 300/100 mg once a day until 30 weeks gestation then 400/100 mg once a day until postpartum hospital discharge; then 300/100 mg once a day after postpartum hospital discharge until 2 week postpartum PK samples drawn

atazanavir/ritonavir dosage #1: atazanavir/ritonavir 300/100 mg once a day

atazanavir/ritonavir dosage #2: atazanavir/ritonavir 400/100mg once a day

HIV-infected pregnant women ≥ 20 weeks gestation who received tenofovir/atazanavir/ritonavir 300/300/100 mg once a day until 30 weeks gestation; then 300/400/100 mg once a day until postpartum hospital discharge; then 300/300/100 mg once a day after postpartum hospital discharge until 2 week postpartum PK samples drawn

atazanavir/ritonavir/tenofovir dosage #1: atazanavir/ritonavir/tenofovir 300/100/300mg q.d.

tenofovir/atazanavir/ritonavir dosage #2: tenofovir/atazanavir/ritonavir 300/400/100 mg once a day

HIV-infected pregnant women ≥ 20 weeks gestation who received nelfinavir [625 mg tablets] 1250 mg twice a day until 30 weeks gestation; then 1875 mg twice a day until postpartum hospital discharge; then 1250 mg twice a day after postpartum hospital discharge until 2 week postpartum PK samples drawn

nelfinavir dosage #1: nelfinavir [625 mg tablets] 1250 mg twice a day

nelfinavir dosage #2: nelfinavir [625 mg tablets] 1875 mg twice a day

HIV-infected pregnant women ≥ 20 weeks gestation who received indinavir/ritonavir 400/100 mg twice a day only to participants enrolling in Thailand

indinavir/ritonavir dosage #2: indinavir/ritonavir 400/100 mg twice a day

HIV-infected pregnant women ≥ 20 weeks gestation who received lopinavir/ritonavir (Alluvia tablets) 400/100 mg [2 tablets] twice day until 30 weeks gestation; then 600/150 mg [3 tablets] twice a day until postpartum hospital discharge; then 400/100 mg [2 tablets] twice a day after postpartum hospital discharge until 2 week postpartum PK sample drawn only to participants enrolling in Uganda

lopinavir/ritonavir dosage #2: lopinavir/ritonavir (Kaletra) 400/100mg twice a day

lopinavir/ritonavir dosage #4: lopinavir/ritonavir (Kaletra) tablets 600/150 mg [3 tablets] twice a day

HIV-infected pregnant women ≥ 20 weeks gestation who received rilpivirine (25 mg q.d.)

rilpivirine: rilpivirine (25 mg q.d.)

HIV- infected women 2-12 weeks postpartum who received atazanavir/ritonavir/tenofovir 300/100/300 mg q.d. postpartum and starting postpartum etonogestrel implant

atazanavir/ritonavir/tenofovir dosage #1: atazanavir/ritonavir/tenofovir 300/100/300mg q.d.

etonogestrel implant: etonogestrel implant contraceptive

HIV- infected women 2-12 weeks postpartum who received lopinavir/ritonavir 400/100 b.i.d. postpartum and starting combined oral contraceptives formulated with 30-35 μg ethinyl estradiol

ethinyl estradiol: oral contraceptives formulated with 30-35 μg ethinyl estradiol

lopinavir/ritonavir dosage #2: lopinavir/ritonavir (Kaletra) 400/100mg twice a day

HIV- infected women 2-12 weeks postpartum who received lopinavir/ritonavir 400/100 b.i.d. postpartum and starting postpartum etonogestrel implant

etonogestrel implant: etonogestrel implant contraceptive

lopinavir/ritonavir dosage #2: lopinavir/ritonavir (Kaletra) 400/100mg twice a day

HIV-infected women 2-12 weeks postpartum who received efavirenz 600mg q.d. postpartum and starting postpartum etonogestrel implant

efavirenz: efavirenz 600 mg q.d.

etonogestrel implant: etonogestrel implant contraceptive

Total of all reporting groups
Overall Number of Baseline Participants 26 30 27 33 29 31 28 12 27 24 2 27 13 2 6 29 28 12 26 17 1 30 29 22 18 21 28 25 29 25 1 35 43 16 12 32 36 38 35 18 26 25 32 25 27 27 28 1113
Hide Baseline Analysis Population Description
The baseline analysis population is all mothers enrolled. Each study arm was designed as a separate single-arm evaluation. Participants were able to enroll in multiple arms, simultaneously; thus, the reporting groups are not mutually exclusive and totals do not represent the number of unique participants. There were 1037 unique mothers, including 8 who enrolled in 3 arms and 60 who enrolled in 2 arms.
Age, Continuous   [1] 
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 26 participants 30 participants 27 participants 33 participants 29 participants 31 participants 28 participants 12 participants 27 participants 24 participants 0 participants 27 participants 13 participants 0 participants 6 participants 29 participants 28 participants 12 participants 26 participants 17 participants 0 participants 30 participants 29 participants 22 participants 18 participants 21 participants 28 participants 25 participants 29 participants 25 participants 0 participants 35 participants 43 participants 16 participants 12 participants 32 participants 36 participants 38 participants 35 participants 18 participants 26 participants 25 participants 32 participants 25 participants 27 participants 27 participants 28 participants 1107 participants
28.8
(21.3 to 34.1)
31.8
(26.7 to 33.8)
29.3
(24.0 to 35.1)
33.6
(26.6 to 35.2)
30.8
(25.3 to 36.1)
32.1
(26.3 to 34.6)
27.7
(22.7 to 31.8)
33.1
(29.3 to 38.4)
30.6
(28.2 to 34.9)
31.4
(26.3 to 34.0)
25.9
(22.0 to 30.2)
32.5
(28.5 to 34.3)
33.2
(26.4 to 35.2)
27.1
(22.7 to 34.6)
32.0
(27.6 to 33.6)
29.5
(24.6 to 34.2)
28.4
(24.8 to 33.5)
31.4
(28.1 to 33.5)
30.7
(25.4 to 34.0)
31.8
(27.6 to 35.2)
31.1
(23.8 to 35.2)
28.7
(21.3 to 36.9)
29.6
(21.9 to 32.2)
30.2
(25.8 to 33.8)
31.0
(26.8 to 34.2)
28.7
(22.9 to 34.5)
29.3
(25.2 to 32.9)
30.4
(27.1 to 34.9)
30.5
(24.8 to 34.5)
25.5
(20.7 to 28.1)
23.8
(21.4 to 25.1)
27.6
(22.8 to 33.0)
27.0
(22.0 to 34.3)
31.0
(27.0 to 35.2)
26.9
(23.2 to 33.7)
28.6
(24.0 to 32.1)
30.4
(24.0 to 33.2)
29.0
(23.5 to 31.1)
26.7
(23.9 to 31.0)
26.9
(21.8 to 31.6)
29.4
(24.1 to 35.8)
26.9
(22.4 to 31.5)
24.3
(21.7 to 30.8)
29.4
(24.3 to 33.9)
[1]
Measure Analysis Population Description: Reporting groups are not mutually exclusive. As such, the numbers in the Total column generated automatically by ClinicalTrials.gov count participants (8 mothers who enrolled in 3 arms and 60 mothers who enrolled in 2 arms) multiple times. For arms with very low enrollment (N<3 participants), no aggregate data are available. Individual participant ages are not entered to avoid making participants identifiable; results from these arms are excluded. Results are shown for N=1032 mothers.
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants 30 participants 27 participants 33 participants 29 participants 31 participants 28 participants 12 participants 27 participants 24 participants 2 participants 27 participants 13 participants 2 participants 6 participants 29 participants 28 participants 12 participants 26 participants 17 participants 1 participants 30 participants 29 participants 22 participants 18 participants 21 participants 28 participants 25 participants 29 participants 25 participants 1 participants 35 participants 43 participants 16 participants 12 participants 32 participants 36 participants 38 participants 35 participants 18 participants 26 participants 25 participants 32 participants 25 participants 27 participants 27 participants 28 participants 1113 participants
Female
26
 100.0%
30
 100.0%
27
 100.0%
33
 100.0%
29
 100.0%
31
 100.0%
28
 100.0%
12
 100.0%
27
 100.0%
24
 100.0%
2
 100.0%
27
 100.0%
13
 100.0%
2
 100.0%
6
 100.0%
29
 100.0%
28
 100.0%
12
 100.0%
26
 100.0%
17
 100.0%
1
 100.0%
30
 100.0%
29
 100.0%
22
 100.0%
18
 100.0%
21
 100.0%
28
 100.0%
25
 100.0%
29
 100.0%
25
 100.0%
1
 100.0%
35
 100.0%
43
 100.0%
16
 100.0%
12
 100.0%
32
 100.0%
36
 100.0%
38
 100.0%
35
 100.0%
18
 100.0%
26
 100.0%
25
 100.0%
32
 100.0%
25
 100.0%
27
 100.0%
27
 100.0%
28
 100.0%
1113
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
[1]
Measure Description: Reporting groups are not mutually exclusive. As such, the numbers in the Total column generated automatically by ClinicalTrials.gov count participants (8 mothers who enrolled in 3 arms and 60 mothers who enrolled in 2 arms) multiple times.
Race/Ethnicity, Customized   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants 30 participants 27 participants 33 participants 29 participants 31 participants 28 participants 12 participants 27 participants 24 participants 0 participants 27 participants 12 participants 0 participants 6 participants 29 participants 28 participants 11 participants 26 participants 16 participants 0 participants 30 participants 29 participants 22 participants 17 participants 21 participants 28 participants 24 participants 29 participants 25 participants 0 participants 35 participants 43 participants 16 participants 12 participants 32 participants 36 participants 38 participants 35 participants 18 participants 26 participants 25 participants 32 participants 25 participants 27 participants 27 participants 28 participants 1102 participants
White Non-Hispanic
0
   0.0%
3
  10.0%
4
  14.8%
3
   9.1%
1
   3.4%
3
   9.7%
0
   0.0%
2
  16.7%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   3.6%
2
  18.2%
4
  15.4%
1
   6.3%
1
   3.3%
7
  24.1%
1
   4.5%
1
   5.9%
6
  28.6%
8
  28.6%
4
  16.7%
1
   3.4%
0
   0.0%
6
  17.1%
3
   7.0%
0
   0.0%
0
   0.0%
2
   6.3%
4
  11.1%
0
   0.0%
3
   8.6%
2
  11.1%
0
   0.0%
0
   0.0%
1
   3.1%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
74
   6.7%
Black Non-Hispanic
13
  50.0%
21
  70.0%
8
  29.6%
20
  60.6%
14
  48.3%
22
  71.0%
18
  64.3%
6
  50.0%
12
  44.4%
21
  87.5%
14
  51.9%
12
 100.0%
3
  50.0%
1
   3.4%
6
  21.4%
5
  45.5%
14
  53.8%
7
  43.8%
13
  43.3%
10
  34.5%
14
  63.6%
5
  29.4%
6
  28.6%
9
  32.1%
12
  50.0%
17
  58.6%
1
   4.0%
7
  20.0%
21
  48.8%
7
  43.8%
4
  33.3%
18
  56.3%
12
  33.3%
5
  13.2%
15
  42.9%
10
  55.6%
0
   0.0%
25
 100.0%
18
  56.3%
6
  24.0%
3
  11.1%
1
   3.7%
0
   0.0%
456
  41.4%
Hispanic (Regardless of Race)
12
  46.2%
4
  13.3%
14
  51.9%
10
  30.3%
13
  44.8%
5
  16.1%
10
  35.7%
2
  16.7%
15
  55.6%
1
   4.2%
4
  14.8%
0
   0.0%
3
  50.0%
16
  55.2%
20
  71.4%
4
  36.4%
7
  26.9%
7
  43.8%
15
  50.0%
11
  37.9%
7
  31.8%
11
  64.7%
7
  33.3%
10
  35.7%
7
  29.2%
11
  37.9%
2
   8.0%
22
  62.9%
18
  41.9%
9
  56.3%
7
  58.3%
11
  34.4%
15
  41.7%
16
  42.1%
16
  45.7%
6
  33.3%
0
   0.0%
0
   0.0%
12
  37.5%
19
  76.0%
24
  88.9%
26
  96.3%
20
  71.4%
449
  40.7%
Asian, Pacific Islander
1
   3.8%
1
   3.3%
1
   3.7%
0
   0.0%
0
   0.0%
1
   3.2%
0
   0.0%
2
  16.7%
0
   0.0%
2
   8.3%
9
  33.3%
0
   0.0%
0
   0.0%
12
  41.4%
1
   3.6%
0
   0.0%
1
   3.8%
1
   6.3%
1
   3.3%
0
   0.0%
0
   0.0%
0
   0.0%
1
   4.8%
0
   0.0%
1
   4.2%
0
   0.0%
21
  84.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
4
  11.1%
17
  44.7%
0
   0.0%
0
   0.0%
26
 100.0%
0
   0.0%
1
   3.1%
0
   0.0%
0
   0.0%
0
   0.0%
8
  28.6%
112
  10.2%
American Indian, Alaskan Native
0
   0.0%
1
   3.3%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   3.4%
0
   0.0%
0
   0.0%
1
   4.8%
0
   0.0%
0
   0.0%
0
   0.0%
1
   4.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
4
   0.4%
More Than One Race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   3.4%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   3.6%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   2.3%
0
   0.0%
1
   8.3%
1
   3.1%
1
   2.8%
0
   0.0%
1
   2.9%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
7
   0.6%
[1]
Measure Analysis Population Description: Reporting groups are not mutually exclusive. As such, the numbers in the Total column generated automatically by ClinicalTrials.gov count participants (8 mothers who enrolled in 3 arms and 60 mothers who enrolled in 2 arms) multiple times. For arms with very low enrollment (N<3 participants), no aggregate data are available. Individual races/ethnicities are not entered to avoid making participants identifiable; results from these arms are excluded. Results are shown for N=1032 mothers.
1.Primary Outcome
Title PK Parameter: Area Under the Curve From 0 to 12 Hours (AUC12) With Median (IQR) for ARVs and TB Drugs
Hide Description Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods. AUC12 (area under the curve from 0 to 12 hours) were determined using the linear trapezoidal rule.
Time Frame Measured in 2nd trimester (20-26 wks gestation), 3rd trimester (30-38 wks gestation), and either 2-3 wks, 2-8 wks, or 6-12 wks postpartum depending on study arm. Blood samples were drawn pre-dose and at 1, 2, 4, 6, 8, and 12 hrs post dosing.
Hide Outcome Measure Data
Hide Analysis Population Description
All mothers with intensive pharmacokinetic (PK) results taking the dose under study at that time period (2nd trimester, 3rd trimester or postpartum). Because participants could enter the study at different time period per the study design, they are not expected to have results at every time period.
Arm/Group Title DRV/RTV 600 or 800 or 900/100mg b.i.d. Then 800 or 900/100mg b.i.d. Then 600/100mg b.i.d. FPV/RTV 700/100mg b.i.d. DRV/RTV 600/100mg b.i.d. NFV Arm 2: 1250mg b.i.d. Then 1875mg b.i.d. Then 1250mg b.i.d.
Hide Arm/Group Description:

HIV-infected pregnant women ≥ 20 weeks gestation NOT on tuberculosis treatment who received:

darunavir/ritonavir (DRV/RTV) twice daily 600/100 mg b.i.d. or 800/100 mg b.i.d. until 30 weeks gestation; then 800/100 mg b.i.d. until postpartum hospital discharge; then 600/100 mg b.i.d. after postpartum hospital discharge until 2 week postpartum PK samples are drawn.

OR darunavir/ritonavir twice daily 600/100 mg b.i.d. or 900/100 mg b.i.d. until 30 weeks gestation; then 900/100 mg b.i.d. until postpartum hospital discharge; then 600/100 mg b.i.d. after postpartum hospital discharge until 2 week postpartum PK samples are drawn.

darunavir/ritonavir dosage #1: darunavir/ritonavir twice daily 600/100 mg b.i.d.

darunavir/ritonavir dosage #2: darunavir/ritonavir twice daily 800/100 mg b.i.d.

darunavir/ritonavir dosage #3: darunavir/ritonavir twice daily 900/100 mg b.i.d.

HIV-infected pregnant women ≥ 20 weeks gestation who received fosamprenavir/ritonavir (FPV/RTV)700/100mg twice a day

fosamprenavir/ritonavir: fosamprenavir/ritonavir 700/100 mg twice a day

HIV-infected pregnant women ≥ 20 weeks gestation who received darunavir/ritonavir (DRV/RTV) 600/100 mg twice a day

darunavir/ritonavir dosage #1: darunavir/ritonavir twice daily 600/100 mg b.i.d.

HIV-infected pregnant women ≥ 20 weeks gestation who received nelfinavir (NFV) [625 mg tablets] 1250 mg twice a day until 30 weeks gestation; then 1875 mg twice a day until postpartum hospital discharge; then 1250 mg twice a day after postpartum hospital discharge until 2 week postpartum PK samples drawn

nelfinavir dosage #1: nelfinavir [625 mg tablets] 1250 mg twice a day

nelfinavir dosage #2: nelfinavir [625 mg tablets] 1875 mg twice a day

Overall Number of Participants Analyzed 24 29 34 18
Median (Inter-Quartile Range)
Unit of Measure: mg*hour/L
2nd Trimester Number Analyzed 9 participants 8 participants 13 participants 18 participants
55.1
(46.4 to 57.7)
43.50
(38.50 to 50.40)
45.8
(36.1 to 53.4)
NA [1] 
(NA to NA)
3rd Trimester Number Analyzed 24 participants 28 participants 34 participants 18 participants
51.8
(41.2 to 57.7)
32.15
(21.45 to 39.70)
45.9
(29.3 to 52.5)
34.2
(27.2 to 46.9)
Postpartum Number Analyzed 24 participants 22 participants 27 participants 16 participants
79.6
(66.6 to 103.0)
51.60
(45.20 to 59.60)
61.7
(49.7 to 80.9)
33.5
(28.6 to 43.5)
[1]
PK parameters not calculated for the 2nd trimester
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection DRV/RTV 600 or 800 or 900/100mg b.i.d. Then 800 or 900/100mg b.i.d. Then 600/100mg b.i.d.
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.055
Comments 2nd Trimester vs. Postpartum
Method Wilcoxon signed-rank test
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric mean ratio
Estimated Value 0.62
Confidence Interval (2-Sided) 90%
0.44 to 0.88
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection DRV/RTV 600 or 800 or 900/100mg b.i.d. Then 800 or 900/100mg b.i.d. Then 600/100mg b.i.d.
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments 3rd Trimester vs. Postpartum
Method Wilcoxon signed-rank test
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric mean ratio
Estimated Value 0.64
Confidence Interval (2-Sided) 90%
0.55 to 0.73
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection FPV/RTV 700/100mg b.i.d.
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.22
Comments 2nd Trimester vs. Postpartum
Method Wilcoxon signed-rank test
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric mean ratio
Estimated Value 0.68
Confidence Interval (2-Sided) 90%
0.44 to 1.04
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection FPV/RTV 700/100mg b.i.d.
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments 3rd Trimester vs. Postpartum
Method Wilcoxon signed-rank test
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric mean ratio
Estimated Value 0.60
Confidence Interval (2-Sided) 90%
0.49 to 0.72
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection DRV/RTV 600/100mg b.i.d.
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments 2nd Trimester vs. Postpartum
Method Wilcoxon signed-rank test
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric mean ratio
Estimated Value 0.76
Confidence Interval (2-Sided) 90%
0.64 to 0.89
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection DRV/RTV 600/100mg b.i.d.
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments 3rd Trimester vs. Postpartum
Method Wilcoxon signed-rank test
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric mean ratio
Estimated Value 0.71
Confidence Interval (2-Sided) 90%
0.57 to 0.88
Estimation Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection NFV Arm 2: 1250mg b.i.d. Then 1875mg b.i.d. Then 1250mg b.i.d.
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.78
Comments 3rd Trimester vs. Postpartum
Method Wilcoxon signed-rank test
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric mean ratio
Estimated Value 0.98
Confidence Interval (2-Sided) 90%
0.71 to 1.35
Estimation Comments [Not Specified]
2.Primary Outcome
Title PK Parameter: Area Under the Curve From 0 to 12 Hours (AUC12) With Median (Range) for ARVs and TB Drugs
Hide Description Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods. AUC12 (area under the curve from 0 to 12 hours) were determined using the linear trapezoidal rule.
Time Frame Measured in 2nd trimester (20-26 wks gestation), 3rd trimester (30-38 wks gestation), and either 2-3 wks, 2-8 wks, or 6-12 wks postpartum depending on study arm. Blood samples were drawn pre-dose and at 1, 2, 4, 6, 8, and 12 hrs post dosing.
Hide Outcome Measure Data
Hide Analysis Population Description
All mothers with intensive pharmacokinetic (PK) results taking the dose under study at that time period (2nd trimester, 3rd trimester or postpartum). Because participants could enter the study at different time period per the study design, they are not expected to have results at every time period.
Arm/Group Title LPV/RTV Arm 3: 400/100mg b.i.d. Then 600/150mg b.i.d. Then 400/100mg b.i.d. RAL 400mg b.i.d. ETR 200mg b.i.d. IDV/RTV Arm 2: 400/100mg q.d. (Only THA)
Hide Arm/Group Description:

HIV-infected pregnant women ≥ 20 weeks gestation who received lopinavir/ritonavir (LPV/RTV) tablets 400/100 mg [2 tablets] twice a day until 30 weeks gestation, then 600/150 mg [3 tablets] twice a day until postpartum hospital discharge; and 400/100 mg [2 tablets] twice a day after postpartum hospital discharge, until 2 week postpartum PK sample is drawn

lopinavir/ritonavir dosage #2: lopinavir/ritonavir (Kaletra) 400/100mg twice a day

lopinavir/ritonavir dosage #4: lopinavir/ritonavir (Kaletra) tablets 600/150 mg [3 tablets] twice a day

HIV-infected pregnant women ≥ 20 weeks gestation who received raltegravir (RAL) 400 mg twice a day

raltegravir: raltegravir 400 mg twice a day

HIV-infected pregnant women ≥ 20 weeks gestation who received etravirine (ETR) 200mg twice a day

etravirine: etravirine 200 mg twice a day

HIV-infected pregnant women ≥ 20 weeks gestation who received indinavir/ritonavir (IDV/RTV) 400/100 mg twice a day only to participants enrolling in Thailand

indinavir/ritonavir dosage #2: indinavir/ritonavir 400/100 mg twice a day

Overall Number of Participants Analyzed 33 42 15 26
Median (Full Range)
Unit of Measure: mg*hour/L
2nd Trimester Number Analyzed 11 participants 16 participants 5 participants 13 participants
72
(47 to 93)
6.6
(2.1 to 18.5)
4.5
(3.4 to 10.7)
14.9
(10.4 to 38.7)
3rd Trimester Number Analyzed 33 participants 41 participants 13 participants 25 participants
96
(43 to 198)
5.4
(1.4 to 35.6)
8.3
(2.7 to 31.0)
16.1
(7.5 to 39.9)
Postpartum Number Analyzed 27 participants 38 participants 8 participants 26 participants
133
(66 to 237)
11.6
(1.6 to 39.9)
5.3
(2.1 to 16.4)
27.1
(18.6 to 44.7)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection LPV/RTV Arm 3: 400/100mg b.i.d. Then 600/150mg b.i.d. Then 400/100mg b.i.d.
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments 2nd Trimester vs. Postpartum
Method Wilcoxon signed-rank test
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric mean ratio
Estimated Value 0.51
Confidence Interval (2-Sided) 90%
0.42 to 0.63
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection LPV/RTV Arm 3: 400/100mg b.i.d. Then 600/150mg b.i.d. Then 400/100mg b.i.d.
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments 3rd Trimester vs. Postpartum
Method Wilcoxon signed-rank test
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric mean ratio
Estimated Value 0.73
Confidence Interval (2-Sided) 90%
0.63 to 0.84
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection RAL 400mg b.i.d.
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.03
Comments 2nd Trimester vs. Postpartum
Method Wilcoxon signed-rank test
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric mean ratio
Estimated Value 0.58
Confidence Interval (2-Sided) 90%
0.34 to 0.98
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection RAL 400mg b.i.d.
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments 3rd Trimester vs. Postpartum
Method Wilcoxon signed-rank test
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric mean ratio
Estimated Value 0.67
Confidence Interval (2-Sided) 90%
0.51 to 0.89
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection ETR 200mg b.i.d.
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0684
Comments 3rd Trimester vs. Postpartum [Note: Comparison of 2nd Trimester vs. Postpartum was not done due to low sample size.]
Method Wilcoxon signed-rank test
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric mean ratio
Estimated Value 1.34
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection IDV/RTV Arm 2: 400/100mg q.d. (Only THA)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments 2nd Trimester vs. Postpartum
Method Wilcoxon signed-rank test
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric mean ratio
Estimated Value 0.58
Confidence Interval (2-Sided) 90%
0.49 to 0.68
Estimation Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection IDV/RTV Arm 2: 400/100mg q.d. (Only THA)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments 3rd Trimester vs. Postpartum
Method Wilcoxon signed-rank test
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric mean ratio
Estimated Value 0.60
Confidence Interval (2-Sided) 90%
0.53 to 0.68
Estimation Comments [Not Specified]
3.Primary Outcome
Title PK Parameter: Area Under the Curve From 0 to 12 Hours (AUC12) With Geometric Mean (95% CI) for ARVs and TB Drugs
Hide Description Measured in 2nd trimester (20-26 wks gestation), 3rd trimester (30-38 wks gestation), and either 2-3 wks, 2-8 wks, or 6-12 wks postpartum depending on study arm. Blood samples were drawn pre-dose and at 1, 2, 4, 6, 8, and 12 hrs post dosing.
Time Frame Measured in 2nd trimester (20-26 wks gestation), 3rd trimester (30-38 wks gestation), and either 2-3 wks, 2-8 wks, or 6-12 wks postpartum depending on study arm. Blood samples were drawn pre-dose and at 1, 2, 4, 6, 8, and 12 hrs post dosing.
Hide Outcome Measure Data
Hide Analysis Population Description
All mothers with intensive pharmacokinetic (PK) results taking the dose under study at that time period (2nd trimester, 3rd trimester or postpartum). Because participants could enter the study at different time period per the study design, they are not expected to have results at every time period.
Arm/Group Title MVC 150 or 300mg b.i.d.
Hide Arm/Group Description:

HIV-infected pregnant women ≥ 20 weeks gestation who received maraviroc (MVC)150 mg or 300 mg twice a day

maraviroc: maraviroc 150 mg or 300 mg twice a day

Overall Number of Participants Analyzed 18
Geometric Mean (95% Confidence Interval)
Unit of Measure: ng*hour/mL
2nd Trimester Number Analyzed 18 participants
NA [1] 
(NA to NA)
3rd Trimester Number Analyzed 12 participants
2717
(2038 to 3622)
Postpartum Number Analyzed 10 participants
3645
(2429 to 5469)
[1]
PK parameters not calculated for the 2nd trimester
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MVC 150 or 300mg b.i.d.
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.008
Comments 3rd Trimester vs. Postpartum
Method t-test, 2 sided
Comments Paired sample t-test on natural log-transformed PK parameter
Method of Estimation Estimation Parameter Geometric mean ratio
Estimated Value 0.72
Confidence Interval (2-Sided) 90%
0.60 to 0.88
Estimation Comments [Not Specified]
4.Primary Outcome
Title PK Parameter: Area Under the Curve From 0 to 24 Hours (AUC24) With Median (IQR) for ARVs and TB Drugs
Hide Description Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods. AUC24 (area under the curve from 0 to 24 hours) were determined using the linear trapezoidal rule.
Time Frame Measured at 2nd trimester (20-26 wks gestation), 3rd trimester (30-38 wks gestation), and either 2-3 wks, 2-8 wks or 6-12 wks postpartum depending on study arm. Blood samples were drawn pre-dose and at 1, 2, 4, 6, 8, 12 and 24 hours post dosing.
Hide Outcome Measure Data
Hide Analysis Population Description
All mothers with intensive pharmacokinetic (PK) results taking the dose under study at that time period (2nd trimester, 3rd trimester or postpartum). Because participants could enter the study at different time period per the study design, they are not expected to have results at every time period.
Arm/Group Title DTG 50mg q.d. TAF 25mg q.d. TAF 10mg q.d. w/COBI TAF 25mg q.d. w/COBI or RTV Boosting EVG/COBI 150/150mg q.d. DRV/COBI 800/150 mg q.d. ATV/COBI 300/150 mg q.d. EFV 600 mg q.d. (Outside THA) ATV/RTV Arm 1: 300/100mg q.d. TFV 300mg q.d. TFV/ATV/RTV Arm 1: 300/300/100mg q.d. DRV/RTV 800/100mg q.d. ATV/RTV Arm 2: 300/100mg q.d. Then 400/100mg q.d. Then 300/100mg q.d. TFV/ATV/RTV Arm 2: 300/300/100mg q.d. Then 300/400/100mg q.d Then 300/300/100mg q.d.
Hide Arm/Group Description:

HIV-infected pregnant women ≥ 20 weeks gestation NOT on tuberculosis treatment who received dolutegravir (DTG) 50 mg q.d.

dolutegravir: dolutegravir 50 mg q.d.

HIV-infected pregnant women ≥ 20 weeks gestation NOT on tuberculosis treatment who received tenofovir alafenamide fumarate (TAF) 25 mg q.d. without cobicistat or ritonavir boosting.

tenofovir alafenamide fumarate (TAF): TAF 25 mg q.d. without cobicistat or ritonavir boosting

HIV-infected pregnant women ≥ 20 weeks gestation NOT on tuberculosis treatment who received tenofovir alafenamide fumarate (TAF) 10 mg q.d. with cobicistat (COBI).

TAF w/cobicistat: TAF 10 mg q.d. with cobicistat

HIV-infected pregnant women ≥ 20 weeks gestation NOT on tuberculosis treatment who received tenofovir alafenamide fumarate (TAF) 25 mg q.d. with cobicistat (COBI) or ritonavir (RTV) boosting.

TAF w/cobicistat or ritonavir: TAF 25 mg q.d. with cobicistat or ritonavir boosting

HIV-infected pregnant women ≥ 20 weeks gestation NOT on tuberculosis treatment who received elvitegravir/cobicistat (EVG/COBI) 150/150 mg q.d

elvitegravir/cobicistat: elvitegravir/cobicistat 150/150 mg q.d.

HIV-infected pregnant women ≥ 20 weeks gestation NOT on tuberculosis treatment who received darunavir/cobicistat (DRV/COBI) 800/150 mg q.d.

darunavir/cobicistat: darunavir/cobicistat 800/150 mg q.d.

HIV-infected pregnant women ≥ 20 weeks gestation NOT on tuberculosis treatment who received atazanavir/cobicistat (ATV/COBI) 300/150 mg q.d.

atazanavir/cobicistat: atazanavir/cobicistat 300/150 mg q.d.

HIV-infected pregnant women ≥ 20 weeks gestation NOT on tuberculosis treatment who received efavirenz (EFV) 600 mg q.d. (Participants outside of Thailand only)

efavirenz: efavirenz 600 mg q.d.

HIV-infected pregnant women ≥ 20 weeks gestation who received atazanavir/ritonavir (ATV/RTV) 300/100 mg once a day

atazanavir/ritonavir dosage #1: atazanavir/ritonavir 300/100 mg once a day

HIV-infected pregnant women ≥ 20 weeks gestation who received tenofovir (TFV) 300 mg once a day

tenofovir: tenofovir 300 mg once a day

HIV-infected pregnant women ≥ 20 weeks gestation who received tenofovir/atazanavir/ritonavir (TFV/ATV/RTV) 300/300/100 mg once a day

atazanavir/ritonavir/tenofovir dosage #1: atazanavir/ritonavir/tenofovir 300/100/300mg q.d.

HIV-infected pregnant women ≥ 20 weeks gestation who received darunavir/ritonavir (DRV/RTV) 800/100 mg once a day

darunavir/ritonavir dosage #4: darunavir/ritonavir once daily 800/100 mg q.d.

HIV-infected pregnant women ≥ 20 weeks gestation who received atazanavir/ritonavir (ATV/RTV) 300/100 mg once a day until 30 weeks gestation then 400/100 mg once a day until postpartum hospital discharge; then 300/100 mg once a day after postpartum hospital discharge until 2 week postpartum PK samples drawn

atazanavir/ritonavir dosage #1: atazanavir/ritonavir 300/100 mg once a day

atazanavir/ritonavir dosage #2: atazanavir/ritonavir 400/100mg once a day

HIV-infected pregnant women ≥ 20 weeks gestation who received tenofovir/atazanavir/ritonavir (TFV/ATV/RTV) 300/300/100 mg once a day until 30 weeks gestation; then 300/400/100 mg once a day until postpartum hospital discharge; then 300/300/100 mg once a day after postpartum hospital discharge until 2 week postpartum PK samples drawn

atazanavir/ritonavir/tenofovir dosage #1: atazanavir/ritonavir/tenofovir 300/100/300mg q.d.

tenofovir/atazanavir/ritonavir dosage #2: tenofovir/atazanavir/ritonavir 300/400/100 mg once a day

Overall Number of Participants Analyzed 29 27 31 29 30 29 11 42 18 37 20 32 37 35
Median (Inter-Quartile Range)
Unit of Measure: mg*hour/L
2nd Trimester Number Analyzed 15 participants 15 participants 17 participants 12 participants 17 participants 16 participants 6 participants 15 participants 1 participants 4 participants 4 participants 15 participants 14 participants 17 participants
47.6
(33.4 to 63.7)
0.171
(0.147 to 0.217)
0.197
(0.145 to 0.354)
0.181
(0.133 to 0.549)
15.3
(11.9 to 19.0)
50.00
(27.032 to 58.90)
25.33
(20.95 to 27.32)
47.30
(40.10 to 79.70)
88.2 [1] 
(NA to NA)
1.9
(1.7 to 2.5)
14.5
(11.3 to 21.0)
64.6
(35.9 to 72.3)
30.6
(19.9 to 39.0)
26.2
(19.9 to 38.4)
3rd Trimester Number Analyzed 28 participants 27 participants 26 participants 27 participants 26 participants 26 participants 8 participants 42 participants 18 participants 37 participants 20 participants 30 participants 37 participants 32 participants
49.2
(36.4 to 62.0)
0.212
(0.153 to 0.290)
0.206
(0.158 to 0.284)
0.257
(0.173 to 0.445)
14.0
(9.1 to 18.8)
42.05
(26.83 to 50.50)
18.85
(11.90 to 31.48)
60.02
(42.96 to 85.40)
41.9
(27.4 to 60.8)
2.4
(1.9 to 3.1)
28.8
(15.4 to 34.5)
63.5
(46.0 to 75.2)
45.7
(30.8 to 57.3)
37.7
(25.7 to 44.4)
Postpartum Number Analyzed 22 participants 25 participants 23 participants 21 participants 25 participants 19 participants 9 participants 40 participants 13 participants 32 participants 19 participants 23 participants 34 participants 34 participants
65.0
(47.8 to 88.4)
0.271
(0.178 to 0.561)
0.216
(0.164 to 0.457)
0.283
(0.161 to 0.507)
21.0
(13.5 to 32.8)
95.55
(67.20 to 118.95)
36.20
(24.09 to 46.14)
62.70
(43.75 to 87.51)
57.9
(47.1 to 64.8)
3.0
(2.2 to 3.7)
39.6
(21.0 to 54.9)
103.9
(85.9 to 135.7)
48.8
(34.9 to 67.5)
58.7
(41.4 to 80.5)
[1]
IQR could not be estimated since only one AUC was calculated
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection DTG 50mg q.d.
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments 2nd Trimester vs. Postpartum
Method Wilcoxon signed-rank test
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric mean ratio
Estimated Value 0.63
Confidence Interval (2-Sided) 90%
0.52 to 0.75
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection DTG 50mg q.d.
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0003
Comments 3rd Trimester vs. Postpartum
Method Wilcoxon signed-rank test
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric mean ratio
Estimated Value 0.71
Confidence Interval (2-Sided) 90%
0.63 to 0.81
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection TAF 25mg q.d.
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.09
Comments 2nd Trimester vs. Postpartum
Method Wilcoxon signed-rank test
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric mean ratio
Estimated Value 0.57
Confidence Interval (2-Sided) 90%
0.34 to 0.98
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection TAF 25mg q.d.
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.004
Comments 3rd Trimester vs. Postpartum
Method Wilcoxon signed-rank test
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric mean ratio
Estimated Value 0.67
Confidence Interval (2-Sided) 90%
0.54 to 0.82
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection TAF 10mg q.d. w/COBI
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.27
Comments 2nd Trimester vs. Postpartum
Method Wilcoxon signed-rank test
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric mean ratio
Estimated Value 0.79
Confidence Interval (2-Sided) 90%
0.50 to 1.27
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection TAF 10mg q.d. w/COBI
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.70
Comments 3rd Trimester vs. Postpartum
Method Wilcoxon signed-rank test
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric mean ratio
Estimated Value 0.86
Confidence Interval (2-Sided) 90%
0.66 to 1.12
Estimation Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection TAF 25mg q.d. w/COBI or RTV Boosting
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.46
Comments 2nd Trimester vs. Postpartum
Method Wilcoxon signed-rank test
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric mean ratio
Estimated Value 0.62
Confidence Interval (2-Sided) 90%
0.29 to 1.34
Estimation Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection TAF 25mg q.d. w/COBI or RTV Boosting
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.50
Comments 3rd Trimester vs. Postpartum
Method Wilcoxon signed-rank test
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric mean ratio
Estimated Value 0.94
Confidence Interval (2-Sided) 90%
0.63 to 1.39
Estimation Comments [Not Specified]
Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection EVG/COBI 150/150mg q.d.
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.10
Comments 2nd Trimester vs. Postpartum
Method Wilcoxon signed-rank test
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric mean ratio
Estimated Value 0.76
Confidence Interval (2-Sided) 90%
0.57 to 1.0
Estimation Comments [Not Specified]
Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection EVG/COBI 150/150mg q.d.
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.10
Comments 3rd Trimester vs. Postpartum
Method Wilcoxon signed-rank test
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric mean ratio
Estimated Value 0.56
Confidence Interval (2-Sided) 90%
0.42 to 0.73
Estimation Comments [Not Specified]
Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection DRV/COBI 800/150 mg q.d.
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.10
Comments 2nd Trimester vs. Postpartum
Method Wilcoxon signed-rank test
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric mean ratio
Estimated Value 0.47
Confidence Interval (2-Sided) 90%
0.33 to 0.68
Estimation Comments [Not Specified]
Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection DRV/COBI 800/150 mg q.d.
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.10
Comments 3rd Trimester vs. Postpartum
Method Wilcoxon signed-rank test
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric mean ratio
Estimated Value 0.44
Confidence Interval (2-Sided) 90%
0.36 to 0.54
Estimation Comments [Not Specified]
Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection ATV/COBI 300/150 mg q.d.
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1875
Comments 2nd Trimester vs. Postpartum
Method Wilcoxon signed-rank test
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric mean ratio
Estimated Value 0.74
Confidence Interval (2-Sided) 90%
0.53 to 1.04
Estimation Comments [Not Specified]
Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection ATV/COBI 300/150 mg q.d.
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1563
Comments 3rd Trimester vs. Postpartum
Method Wilcoxon signed-rank test
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric mean ratio
Estimated Value 0.46
Confidence Interval (2-Sided) 90%
0.19 to 1.11
Estimation Comments [Not Specified]
Hide Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection EFV 600 mg q.d. (Outside THA)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.241
Comments 2nd Trimester vs. Postpartum
Method Wilcoxon signed-rank test
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric mean ratio
Estimated Value 0.94
Confidence Interval (2-Sided) 90%
0.85 to 1.03
Estimation Comments [Not Specified]
Hide Statistical Analysis 16
Statistical Analysis Overview Comparison Group Selection EFV 600 mg q.d. (Outside THA)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.837
Comments 3rd Trimester vs. Postpartum
Method Wilcoxon signed-rank test
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric mean ratio
Estimated Value 1.09
Confidence Interval (2-Sided) 90%
0.90 to 1.32
Estimation Comments [Not Specified]
Hide Statistical Analysis 17
Statistical Analysis Overview Comparison Group Selection ATV/RTV Arm 1: 300/100mg q.d.
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments 3rd Trimester vs. Postpartum [Note: Comparison of 2nd Trimester vs. Postpartum was not done due to low sample size.]
Method Wilcoxon signed-rank test
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric mean ratio
Estimated Value 0.70
Confidence Interval (2-Sided) 90%
0.55 to 0.88
Estimation Comments [Not Specified]
Hide Statistical Analysis 18
Statistical Analysis Overview Comparison Group Selection TFV 300mg q.d.
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0046
Comments 3rd Trimester vs. Postpartum [Note: Comparison of 2nd Trimester vs. Postpartum was not done due to low sample size.]
Method Wilcoxon signed-rank test
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric mean ratio
Estimated Value 0.80
Confidence Interval (2-Sided) 90%
0.72 to 0.89
Estimation Comments [Not Specified]
Hide Statistical Analysis 19
Statistical Analysis Overview Comparison Group Selection TFV/ATV/RTV Arm 1: 300/300/100mg q.d.
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments 3rd Trimester vs. Postpartum [Note: Comparison of 2nd Trimester vs. Postpartum was not done due to low sample size.]
Method Wilcoxon signed-rank test
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric mean ratio
Estimated Value 0.66
Confidence Interval (2-Sided) 90%
0.52 to 0.85
Estimation Comments [Not Specified]
Hide Statistical Analysis 20
Statistical Analysis Overview Comparison Group Selection DRV/RTV 800/100mg q.d.
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments 2nd Trimester vs. Postpartum
Method Wilcoxon signed-rank test
Comments [Not Specified]
Hide Statistical Analysis 21
Statistical Analysis Overview Comparison Group Selection DRV/RTV 800/100mg q.d.
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments 3rd Trimester vs. Postpartum
Method Wilcoxon signed-rank test
Comments [Not Specified]
Hide Statistical Analysis 22
Statistical Analysis Overview Comparison Group Selection ATV/RTV Arm 2: 300/100mg q.d. Then 400/100mg q.d. Then 300/100mg q.d.
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments 2nd Trimester vs. Postpartum
Method Wilcoxon signed-rank test
Comments [Not Specified]
Hide Statistical Analysis 23
Statistical Analysis Overview Comparison Group Selection ATV/RTV Arm 2: 300/100mg q.d. Then 400/100mg q.d. Then 300/100mg q.d.
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments 3rd Trimester vs. Postpartum
Method Wilcoxon signed-rank test
Comments [Not Specified]
Hide Statistical Analysis 24
Statistical Analysis Overview Comparison Group Selection TFV/ATV/RTV Arm 2: 300/300/100mg q.d. Then 300/400/100mg q.d Then 300/300/100mg q.d.
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments 2nd Trimester vs. Postpartum
Method Wilcoxon signed-rank test
Comments [Not Specified]
Hide Statistical Analysis 25
Statistical Analysis Overview Comparison Group Selection TFV/ATV/RTV Arm 2: 300/300/100mg q.d. Then 300/400/100mg q.d Then 300/300/100mg q.d.
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments 3rd Trimester vs. Postpartum
Method Wilcoxon signed-rank test
Comments [Not Specified]
5.Primary Outcome
Title PK Parameter: Area Under the Curve From 0 to 24 Hours (AUC24) With Median (Range) for ARVs and TB Drugs
Hide Description Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods. AUC24h (area-under-the-curve from 0 to 24 hours) were determined using the trapezoidal rule.
Time Frame Measured at 2nd trimester (20-26 wks gestation), 3rd trimester (30-38 wks gestation), and either 2-3 wks, 2-8 wks or 6-12 wks postpartum depending on study arm. Blood samples were drawn pre-dose and at 1, 2, 4, 6, 8, 12 and 24 hours post dosing.
Hide Outcome Measure Data
Hide Analysis Population Description
All mothers with intensive pharmacokinetic (PK) results taking the dose under study at that time period (2nd trimester, 3rd trimester or postpartum). Because participants could enter the study at different time period per the study design, they are not expected to have results at every time period. No 2nd trimester data were available for the EFV 600mg q.d. arm.
Arm/Group Title EFV 600mg q.d. RPV 25mg q.d.
Hide Arm/Group Description:

HIV-infected pregnant women ≥ 20 weeks gestation who received efavirenz (EFV) 600 mg once a day

efavirenz: efavirenz 600 mg q.d.

HIV-infected pregnant women ≥ 20 weeks gestation who received rilpivirine (RPV) (25 mg q.d.)

rilpivirine: rilpivirine (25 mg q.d.)

Overall Number of Participants Analyzed 25 32
Median (Full Range)
Unit of Measure: mg*hour/L
2nd Trimester Number Analyzed 0 participants 18 participants
1.969
(0.867 to 4.987)
3rd Trimester Number Analyzed 25 participants 30 participants
55.4
(13.5 to 220.3)
1.669
(0.556 to 4.312)
Postpartum Number Analyzed 25 participants 28 participants
58.3
(22.7 to 214.4)
2.387
(0.188 to 6.736)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection EFV 600mg q.d.
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.07
Comments 3rd Trimester vs. Postpartum
Method Wilcoxon signed-rank test
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric mean ratio
Estimated Value 0.97
Confidence Interval (2-Sided) 90%
0.83 to 1.13
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection RPV 25mg q.d.
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments 2nd Trimester vs. Postpartum
Method Wilcoxon signed-rank test
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric mean ratio
Estimated Value 0.77
Confidence Interval (2-Sided) 90%
0.61 to 0.96
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection RPV 25mg q.d.
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments 3rd Trimester vs. Postpartum
Method Wilcoxon signed-rank test
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric mean ratio
Estimated Value 0.80
Confidence Interval (2-Sided) 90%
0.62 to 1.03
Estimation Comments [Not Specified]
6.Primary Outcome
Title PK Parameter: Maximum Concentration (Cmax) in mg/L With Median (IQR) for ARVs and TB Drugs
Hide Description Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods. Cmax was the maximum observed concentration after a dose.
Time Frame Measured at 2nd trimester (20-26 wks gestation), 3rd trimester (30-38 wks gestation), and either 2-3 wks, 2-8 wks or 6-12 wks postpartum depending on study arm; Blood samples were drawn pre-dose and at 1, 2, 4, 6, 8,12 (and 24) hours post dosing.
Hide Outcome Measure Data
Hide Analysis Population Description
All mothers with intensive pharmacokinetic (PK) results taking the dose under study at that time period (2nd trimester, 3rd trimester or postpartum). Because participants could enter the study at different time period per the study design, they are not expected to have results at every time period.
Arm/Group Title DRV/RTV 600 or 800 or 900/100mg b.i.d. Then 800 or 900/100mg b.i.d. Then 600/100mg b.i.d. DTG 50mg q.d. DRV/COBI 800/150 mg q.d. ATV/COBI 300/150 mg q.d. EFV 600 mg q.d. (Outside THA) FPV/RTV 700/100mg b.i.d. ATV/RTV Arm 1: 300/100mg q.d. TFV 300mg q.d. TFV/ATV/RTV Arm 1: 300/300/100mg q.d. EFV 600mg q.d. DRV/RTV 800/100mg q.d. DRV/RTV 600/100mg b.i.d. ATV/RTV Arm 2: 300/100mg q.d. Then 400/100mg q.d. Then 300/100mg q.d. TFV/ATV/RTV Arm 2: 300/300/100mg q.d. Then 300/400/100mg q.d Then 300/300/100mg q.d. NFV Arm 2: 1250mg b.i.d. Then 1875mg b.i.d. Then 1250mg b.i.d. IDV/RTV Arm 2: 400/100mg q.d. (Only THA)
Hide Arm/Group Description:

HIV-infected pregnant women ≥ 20 weeks gestation NOT on tuberculosis treatment who received:

darunavir/ritonavir (DRV/RTV) twice daily 600/100 mg b.i.d. or 800/100 mg b.i.d. until 30 weeks gestation; then 800/100 mg b.i.d. until postpartum hospital discharge; then 600/100 mg b.i.d. after postpartum hospital discharge until 2 week postpartum PK samples are drawn.

OR darunavir/ritonavir twice daily 600/100 mg b.i.d. or 900/100 mg b.i.d. until 30 weeks gestation; then 900/100 mg b.i.d. until postpartum hospital discharge; then 600/100 mg b.i.d. after postpartum hospital discharge until 2 week postpartum PK samples are drawn.

darunavir/ritonavir dosage #1: darunavir/ritonavir twice daily 600/100 mg b.i.d.

darunavir/ritonavir dosage #2: darunavir/ritonavir twice daily 800/100 mg b.i.d.

darunavir/ritonavir dosage #3: darunavir/ritonavir twice daily 900/100 mg b.i.d.

HIV-infected pregnant women ≥ 20 weeks gestation NOT on tuberculosis treatment who received dolutegravir (DTG) 50 mg q.d.

dolutegravir: dolutegravir 50 mg q.d.

HIV-infected pregnant women ≥ 20 weeks gestation NOT on tuberculosis treatment who received darunavir/cobicistat (DRV/COBI) 800/150 mg q.d.

darunavir/cobicistat: darunavir/cobicistat 800/150 mg q.d.

HIV-infected pregnant women ≥ 20 weeks gestation NOT on tuberculosis treatment who received atazanavir/cobicistat (ATV/COBI) 300/150 mg q.d.

atazanavir/cobicistat: atazanavir/cobicistat 300/150 mg q.d.

HIV-infected pregnant women ≥ 20 weeks gestation NOT on tuberculosis treatment who received efavirenz (EFV) 600 mg q.d. (Participants outside of Thailand only)

efavirenz: efavirenz 600 mg q.d.

HIV-infected pregnant women ≥ 20 weeks gestation who received fosamprenavir/ritonavir (FPV/RTV)700/100mg twice a day

fosamprenavir/ritonavir: fosamprenavir/ritonavir 700/100 mg twice a day

HIV-infected pregnant women ≥ 20 weeks gestation who received atazanavir/ritonavir (ATV/RTV) 300/100 mg once a day

atazanavir/ritonavir dosage #1: atazanavir/ritonavir 300/100 mg once a day

HIV-infected pregnant women ≥ 20 weeks gestation who received tenofovir (TFV) 300 mg once a day

tenofovir: tenofovir 300 mg once a day

HIV-infected pregnant women ≥ 20 weeks gestation who received tenofovir/atazanavir/ritonavir (TFV/ATV/RTV) 300/300/100 mg once a day

atazanavir/ritonavir/tenofovir dosage #1: atazanavir/ritonavir/tenofovir 300/100/300mg q.d.

HIV-infected pregnant women ≥ 20 weeks gestation who received efavirenz (EFV) 600 mg once a day

efavirenz: efavirenz 600 mg q.d.

HIV-infected pregnant women ≥ 20 weeks gestation who received darunavir/ritonavir (DRV/RTV) 800/100 mg once a day

darunavir/ritonavir dosage #4: darunavir/ritonavir once daily 800/100 mg q.d.

HIV-infected pregnant women ≥ 20 weeks gestation who received darunavir/ritonavir (DRV/RTV) 600/100 mg twice a day

darunavir/ritonavir dosage #1: darunavir/ritonavir twice daily 600/100 mg b.i.d.

HIV-infected pregnant women ≥ 20 weeks gestation who received atazanavir/ritonavir (ATV/RTV) 300/100 mg once a day until 30 weeks gestation then 400/100 mg once a day until postpartum hospital discharge; then 300/100 mg once a day after postpartum hospital discharge until 2 week postpartum PK samples drawn

atazanavir/ritonavir dosage #1: atazanavir/ritonavir 300/100 mg once a day

atazanavir/ritonavir dosage #2: atazanavir/ritonavir 400/100mg once a day

HIV-infected pregnant women ≥ 20 weeks gestation who received tenofovir/atazanavir/ritonavir (TFV/ATV/RTV) 300/300/100 mg once a day until 30 weeks gestation; then 300/400/100 mg once a day until postpartum hospital discharge; then 300/300/100 mg once a day after postpartum hospital discharge until 2 week postpartum PK samples drawn

atazanavir/ritonavir/tenofovir dosage #1: atazanavir/ritonavir/tenofovir 300/100/300mg q.d.

tenofovir/atazanavir/ritonavir dosage #2: tenofovir/atazanavir/ritonavir 300/400/100 mg once a day

HIV-infected pregnant women ≥ 20 weeks gestation who received nelfinavir (NFV) [625 mg tablets] 1250 mg twice a day until 30 weeks gestation; then 1875 mg twice a day until postpartum hospital discharge; then 1250 mg twice a day after postpartum hospital discharge until 2 week postpartum PK samples drawn

nelfinavir dosage #1: nelfinavir [625 mg tablets] 1250 mg twice a day

nelfinavir dosage #2: nelfinavir [625 mg tablets] 1875 mg twice a day

HIV-infected pregnant women ≥ 20 weeks gestation who received indinavir/ritonavir (IDV/RTV) 400/100 mg twice a day only to participants enrolling in Thailand

indinavir/ritonavir dosage #2: indinavir/ritonavir 400/100 mg twice a day

Overall Number of Participants Analyzed 26 29 29 11 42 29 18 37 20 25 32 34 37 35 18 26
Median (Inter-Quartile Range)
Unit of Measure: mg/L
2nd Trimester Number Analyzed 9 participants 15 participants 16 participants 6 participants 15 participants 8 participants 1 participants 4 participants 4 participants 0 participants 15 participants 13 participants 14 participants 17 participants 2 participants 13 participants
6.22
(5.30 to 8.42)
3.62
(2.57 to 4.63)
4.59
(2.38 to 6.12)
2.82
(2.65 to 3.65)
3.87
(2.82 to 5.67)
5.61
(4.47 to 6.64)
NA [1] 
(NA to NA)
0.250
(0.202 to 0.355)
1.2
(0.8 to 1.7)
6.77
(4.35 to 7.84)
5.64
(3.78 to 6.07)
3.11
(1.95 to 4.06)
2.73
(1.65 to 4.02)
NA [2] 
(NA to NA)
3.89
(3.36 to 4.29)
3rd Trimester Number Analyzed 24 participants 28 participants 26 participants 8 participants 42 participants 28 participants 18 participants 37 participants 20 participants 25 participants 30 participants 34 participants 37 participants 32 participants 18 participants 25 participants
6.55
(5.38 to 7.43)
3.54
(2.66 to 4.24)
3.67
(3.29 to 4.65)
2.20
(0.94 to 3.35)
5.13
(3.62 to 5.9)
5.12
(3.6 to 6.26)
3.6
(2.8 to 5.1)
0.245
(0.207 to 0.334)
2.5
(1.6 to 3)
5.44
(4.15 to 6.93)
5.78
(4.31 to 7.29)
5.53
(4.44 to 7.10)
4.51
(3.28 to 5.84)
3.56
(2.28 to 4.32)
5.1
(4.3 to 6.5)
3.62
(2.69 to 4.80)
Postpartum Number Analyzed 24 participants 22 participants 19 participants 9 participants 40 participants 22 participants 13 participants 32 participants 19 participants 25 participants 23 participants 27 participants 34 participants 34 participants 16 participants 26 participants
8.96
(7.93 to 10.85)
4.85
(3.83 to 5.97)
7.04
(5.70 to 10.75)
3.90
(1.93 to 4.60)
4.41
(3.38 to 5.79)
6.75
(4.31 to 9.24)
4.1
(3 to 5.8)
0.298
(0.200 to 0.341)
4.1
(1.7 to 4.5)
5.10
(3.95 to 5.85)
8.11
(6.93 to 10.3)
7.78
(6.11 to 9.54)
4.52
(2.31 to 5.61)
5.43
(3.81 to 6.80)
5.0
(4.2 to 5.9)
5.37
(4.78 to 7.41)
[1]
Only one participant had data for 2nd Trimester. Individual participant level data are not entered due to being potentially identifiable.
[2]
Only 2 participants had data available. Data not entered due to extreme small sample size and concerns regarding confidentiality.
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection DRV/RTV 600 or 800 or 900/100mg b.i.d. Then 800 or 900/100mg b.i.d. Then 600/100mg b.i.d.
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.148
Comments 2nd Trimester vs. Postpartum
Method Wilcoxon signed-rank test
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric mean of ratio
Estimated Value 0.81
Confidence Interval (2-Sided) 90%
0.64 to 1.01
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection DRV/RTV 600 or 800 or 900/100mg b.i.d. Then 800 or 900/100mg b.i.d. Then 600/100mg b.i.d.
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments 3rd Trimester vs. Postpartum
Method Wilcoxon signed-rank test
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric mean of ratio
Estimated Value 0.71
Confidence Interval (2-Sided) 90%
0.62 to 0.81
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection DTG 50mg q.d.
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0098
Comments 2nd Trimester vs. Postpartum
Method Wilcoxon signed-rank test
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric mean of ratio
Estimated Value 0.74
Confidence Interval (2-Sided) 90%
0.61 to 0.89
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection DTG 50mg q.d.
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0025
Comments 3rd Trimester vs. Postpartum
Method Wilcoxon signed rank test
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric mean of ratio
Estimated Value 0.75
Confidence Interval (2-Sided) 90%
0.64 to 0.88
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection DRV/COBI 800/150 mg q.d.
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments 3rd Trimester vs. Postpartum
Method Wilcoxon signed rank test
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric mean of ratio
Estimated Value 0.54
Confidence Interval (2-Sided) 90%
0.46 to 0.64
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection DRV/COBI 800/150 mg q.d.
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0024
Comments 2nd Trimester vs. Postpartum
Method Wilcoxon signed rank test
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric mean of ratio
Estimated Value 0.56
Confidence Interval (2-Sided) 90%
0.41 to 0.76
Estimation Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection ATV/COBI 300/150 mg q.d.
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.438
Comments 2nd Trimester vs. Postpartum
Method Wilcoxon signed rank test
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric mean of ratio
Estimated Value 0.795
Confidence Interval (2-Sided) 90%
0.499 to 1.269
Estimation Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection ATV/COBI 300/150 mg q.d.
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.219
Comments 3rd Trimester vs. Postpartum
Method Wilcoxon signed rank test
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric mean of ratio
Estimated Value 0.531
Confidence Interval (2-Sided) 90%
0.186 to 1.512
Estimation Comments [Not Specified]
Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection EFV 600 mg q.d. (Outside THA)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.296
Comments 2nd Trimester vs. Postpartum
Method Wilcoxon signed rank test
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric mean of ratio
Estimated Value 1.05
Confidence Interval (2-Sided) 90%
0.94 to 1.18
Estimation Comments [Not Specified]
Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection EFV 600 mg q.d. (Outside THA)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.007
Comments 3rd Trimester vs. Postpartum
Method Wilcoxon signed rank test
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric mean of ratio
Estimated Value 1.26
Confidence Interval (2-Sided) 90%
1.01 to 1.56
Estimation Comments [Not Specified]
Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection FPV/RTV 700/100mg b.i.d.
Comments FPV was analyzed as the form of amprenavir (APV). FPV is the prodrug of APV.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.16
Comments 2nd Trimester vs Postpartum
Method Wilcoxon signed rank test
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric mean of ratio
Estimated Value 0.83
Confidence Interval (2-Sided) 90%
0.56 to 1.22
Estimation Comments [Not Specified]
Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection FPV/RTV 700/100mg b.i.d.
Comments FPV was analyzed in the form of amprenavir (APV). FPV is the prodrug of APV.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.03
Comments [Not Specified]
Method Wilcoxson signed rank test
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric mean of ratio
Estimated Value 0.74
Confidence Interval (2-Sided) 90%
0.58 to 0.93
Estimation Comments [Not Specified]
Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection ATV/RTV Arm 1: 300/100mg q.d.
Comments This analysis was for ATV.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments 3rd Trimester vs. Postpartum (No comparison was done for 2nd Trimester vs. Postpartum since the sample size for 2nd trimester was 1)
Method Wilcoxon signed rank test
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric mean of ratio
Estimated Value 0.86
Confidence Interval (2-Sided) 90%
0.68 to 1.08
Estimation Comments [Not Specified]
Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection TFV 300mg q.d.
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1636
Comments Third Trimester vs. Postpartum (No comparison was done for Second Trimester vs. Postpartum since only 4 participants had Second Trimester data)
Method Wilcoxon signed rank test
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric mean of ratio
Estimated Value 0.89
Confidence Interval (2-Sided) 90%
0.79 to 1.01
Estimation Comments [Not Specified]
Hide Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection TFV/ATV/RTV Arm 1: 300/300/100mg q.d.
Comments This analysis was for ATV.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments 3rd Trimester vs Postpartum (No comparison was done for Second Trimester vs. Postpartum since only 4 participants had Second Trimester data)
Method Wilcoxon signed rank test
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric mean of ratio
Estimated Value 0.69
Confidence Interval (2-Sided) 90%
0.53 to 0.91
Estimation Comments [Not Specified]
Hide Statistical Analysis 16
Statistical Analysis Overview Comparison Group Selection EFV 600mg q.d.
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.16
Comments 3rd Trimester vs. Postpartum (No comparison was done for Second Trimester vs. Postpartum since there was no Second Trimester data available)
Method Wilcoxon signed rank test
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric mean of ratio
Estimated Value 1.11
Confidence Interval (2-Sided) 90%
0.99 to 1.24
Estimation Comments [Not Specified]
Hide Statistical Analysis 17
Statistical Analysis Overview Comparison Group Selection DRV/RTV 800/100mg q.d.
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments 2nd Trimester vs. Postpartum
Method Wilcoxon signed-rank test
Comments [Not Specified]
Hide Statistical Analysis 18
Statistical Analysis Overview Comparison Group Selection DRV/RTV 800/100mg q.d.
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments 3rd Trimester vs. Postpartum
Method Wilcoxon signed-rank test
Comments [Not Specified]