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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)

Brief Summary:
IMPAACT P1026s is a Phase IV prospective clinical study to evaluate the pharmacokinetics (PKs) of antiretroviral (ARV) and tuberculosis (TB) medications in pregnant women and their infants. (Pharmacokinetics are the various interactions between a drug and the body.) This study also evaluated the PKs of certain ARVs in postpartum women before and after starting hormonal contraceptives. The PKs of these drugs were evaluated by measuring the amount of medicine present in blood and/or vaginal secretions.

Condition or disease Intervention/treatment
HIV Infections 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

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Layout table for study information
Study Type : Observational
Actual Enrollment : 1578 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pharmacokinetic Properties of Antiretroviral and Related Drugs During Pregnancy and Postpartum
Actual Study Start Date : June 9, 2003
Actual Primary Completion Date : September 30, 2020
Actual Study Completion Date : September 30, 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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.

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

darunavir/ritonavir (DRV/RTV) 600/100 mg twice daily (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.

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

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

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

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

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

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

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

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

DRV/COBI 800/150 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.
Drug: darunavir/cobicistat
darunavir/cobicistat 800/150 mg q.d.

ATV/COBI 300/150 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.
Drug: atazanavir/cobicistat
atazanavir/cobicistat 300/150 mg q.d.

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

EFV 600mg q.d. and at least one 1st line TB drug

HIV-infected pregnant women ≥ 20 weeks gestation who received efavirenz (EFV) 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.
Drug: efavirenz
efavirenz 600 mg q.d.

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

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

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

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

LPV/RTV 800/200mg b.i.d. and at least one 1st line TB drug

HIV-infected pregnant women ≥ 20 weeks gestation who received lopinavir/ritonavir (LPV/RTV) 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.
Drug: lopinavir/ritonavir dosage #1
lopinavir/ritonavir 800/200mg b.i.d.

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

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

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

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

No ARVs and at least two 1st line TB drugs

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

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

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

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

At least two 2nd line TB drugs w/ or w/out ARVs

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
Drug: kanamycin
kanamycin (2nd line TB drug)

Drug: amikacin
amikacin (2nd line TB drug)

Drug: capreomycin
capreomycin (2nd line TB drug)

Drug: moxifloxacin
moxifloxacin (2nd line TB drug)

Drug: levoflaxacin
levofloxacin (2nd line TB drug)

Drug: ofloxacin
ofloxacin (2nd line TB drug)

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

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

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

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

Drug: bedaquiline
bedaquiline (2nd line TB drug)

Drug: clofazamine
clofazamine (2nd TB drug)

Drug: delamanid
delamanid (2nd line TB drug)

Drug: linezolid
linezolid (2nd line TB drug)

Drug: pretomanid
pretomanid (2nd line TB drug)

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

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

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

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

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

Drug: etonogestrel implant
etonogestrel implant contraceptive

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

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

ATV/RTV/TFV 300/100/300mg q.d. with 30-35ug EE
HIV-infected women 2-12 weeks (14-84 days) post-delivery who received atazanavir/ritonavir/tenofovir (ATV/RTV/TFV) 300/100/300 mg q.d. postpartum and starting combined oral contraceptives formulated with 30-35 μg ethinyl estradiol (EE)
Drug: atazanavir/ritonavir/tenofovir dosage #1
atazanavir/ritonavir/tenofovir 300/100/300mg q.d.

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

NVP 200mg b.i.d
HIV-infected pregnant women ≥ 26 weeks gestation who received nevirapine (NVP) 200 mg twice a day
Drug: nevirapine
nevirapine 200 mg twice a day

APV 1200mg b.i.d
HIV-infected pregnant women ≥ 26 weeks gestation who received amprenavir (APV) 1200mg twice a day
Drug: amprenavir
amprenavir 1200mg twice a day

ABC 300mg b.i.d
HIV-infected pregnant women ≥ 20 weeks gestation who received abacavir (ABC) 300mg twice a day
Drug: abacavir
abacavir 300mg twice a day

LPV/RTV Arm 1: 400/100mg b.i.d
HIV-infected pregnant women ≥ 26 weeks gestation who received lopinavir/ritonavir (LPV/RTV) 400/100mg twice a day
Drug: lopinavir/ritonavir dosage #2
lopinavir/ritonavir (Kaletra) 400/100mg twice a day

IDV/RTV Arm 1: 800/100mg b.i.d
HIV-infected pregnant women ≥ 26 weeks gestation who received indinavir/ritonavir (IDV/RTV) 800/100 mg twice a day
Drug: indinavir/ritonavir dosage #1
indinavir/ritonavir 800/100mg twice a day

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

LPV/RTV Arm 2: 400/100mg b.i.d. then 533/133mg b.i.d.
HIV-infected pregnant women ≥ 20 weeks gestation who received Kaletra (LPV/RTV) 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
Drug: lopinavir/ritonavir dosage #2
lopinavir/ritonavir (Kaletra) 400/100mg twice a day

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

ATV/RTV Arm 1: 300/100mg q.d.
HIV-infected pregnant women ≥ 20 weeks gestation who received atazanavir/ritonavir (ATV/RTV) 300/100 mg once a day
Drug: atazanavir/ritonavir dosage #1
atazanavir/ritonavir 300/100 mg once a day

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

FTC 200mg q.d.
HIV-infected pregnant women ≥ 20 weeks gestation who received emtricitabine (FTC) 200 mg once a day
Drug: emtricitabine
emtricitabine 200 mg once a day

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

TFV/ATV/RTV Arm 1: 300/300/100mg q.d.
HIV-infected pregnant women ≥ 20 weeks gestation who received tenofovir/atazanavir/ritonavir (TFV/ATV/RTV) 300/300/100 mg once a day
Drug: atazanavir/ritonavir/tenofovir dosage #1
atazanavir/ritonavir/tenofovir 300/100/300mg q.d.

NFV Arm 1: 1250mg b.i.d.
HIV-infected pregnant women ≥ 20 weeks gestation who received nelfinavir (NFV) [625 mg tablets] 1250 mg twice a day
Drug: nelfinavir dosage #1
nelfinavir [625 mg tablets] 1250 mg twice a day

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

TPV/RTV 500/200mg b.i.d.
HIV-infected pregnant women ≥ 20 weeks gestation who received tipranavir/ritonavir (TPV/RTV) 500/200 mg twice a day
Drug: tipranavir/ritonavir
tipranavir/ritonavir 500/200 mg twice a day

LPV/RTV Arm 3: 400/100mg b.i.d. then 600/150mg b.i.d. then 400/100mg b.i.d.
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
Drug: lopinavir/ritonavir dosage #2
lopinavir/ritonavir (Kaletra) 400/100mg twice a day

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

RAL 400mg b.i.d.
HIV-infected pregnant women ≥ 20 weeks gestation who received raltegravir (RAL) 400 mg twice a day
Drug: raltegravir
raltegravir 400 mg twice a day

ETR 200mg b.i.d.
HIV-infected pregnant women ≥ 20 weeks gestation who received etravirine (ETR) 200mg twice a day
Drug: etravirine
etravirine 200 mg twice a day

MVC 150 or 300mg b.i.d.
HIV-infected pregnant women ≥ 20 weeks gestation who received maraviroc (MVC)150 mg or 300 mg twice a day
Drug: maraviroc
maraviroc 150 mg or 300 mg twice a day

DRV/RTV 800/100mg q.d.
HIV-infected pregnant women ≥ 20 weeks gestation who received darunavir/ritonavir (DRV/RTV) 800/100 mg once a day
Drug: darunavir/ritonavir dosage #4
darunavir/ritonavir once daily 800/100 mg q.d.

DRV/RTV 600/100mg b.i.d.
HIV-infected pregnant women ≥ 20 weeks gestation who received darunavir/ritonavir (DRV/RTV) 600/100 mg twice a day
Drug: darunavir/ritonavir dosage #1
darunavir/ritonavir twice daily 600/100 mg b.i.d.

ATV/RTV Arm 2: 300/100mg q.d. then 400/100mg q.d. then 300/100mg 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
Drug: atazanavir/ritonavir dosage #1
atazanavir/ritonavir 300/100 mg once a day

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

TFV/ATV/RTV Arm 2: 300/300/100mg q.d. then 300/400/100mg q.d then 300/300/100mg q.d.
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
Drug: atazanavir/ritonavir/tenofovir dosage #1
atazanavir/ritonavir/tenofovir 300/100/300mg q.d.

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

NFV Arm 2: 1250mg b.i.d. then 1875mg b.i.d. then 1250mg 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
Drug: nelfinavir dosage #1
nelfinavir [625 mg tablets] 1250 mg twice a day

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

IDV/RTV Arm 2: 400/100mg q.d. (only THA)
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
Drug: indinavir/ritonavir dosage #2
indinavir/ritonavir 400/100 mg twice a day

LPV/RTV Arm 4: 400/100mg b.i.d. then 600/150mg b.i.d. then 400/100mg b.i.d. (only African sites)
HIV-infected pregnant women ≥ 20 weeks gestation who received lopinavir/ritonavir (LPV/RTV, 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
Drug: lopinavir/ritonavir dosage #2
lopinavir/ritonavir (Kaletra) 400/100mg twice a day

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

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

NVP 200mg b.i.d. and RIF and at least one 1st line TB drug

HIV-infected pregnant women > 20 weeks gestation who received nevirapine (NVP) 200 mg b.i.d AND rifampicin 8-12 mg/kg (max 600 mg) q.d.; 8-12 mg/kg (max 900 mg) t.i.w. and at least one of the following drugs at study entry:

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

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

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

Drug: nevirapine
nevirapine 200 mg twice a day

ATV/RTV/TFV 300/100/300mg q.d. with ENG
HIV- infected women 2-12 weeks postpartum who received atazanavir/ritonavir/tenofovir (ATV/RTV/TFV) 300/100/300 mg q.d. postpartum and starting postpartum etonogestrel (ENG) implant
Drug: atazanavir/ritonavir/tenofovir dosage #1
atazanavir/ritonavir/tenofovir 300/100/300mg q.d.

Drug: etonogestrel implant
etonogestrel implant contraceptive

LPV/RTV 400/100 b.i.d. with 30-35ug EE
HIV- infected women 2-12 weeks postpartum who received lopinavir/ritonavir (LPV/RTV) 400/100 b.i.d. postpartum and starting combined oral contraceptives formulated with 30-35 μg ethinyl estradiol (EE)
Drug: ethinyl estradiol
oral contraceptives formulated with 30-35 μg ethinyl estradiol

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

LPV/RTV 400/100 b.i.d. with ENG
HIV- infected women 2-12 weeks postpartum who received lopinavir/ritonavir (LPV/RTV) 400/100 b.i.d. postpartum and starting postpartum etonogestrel (ENG) implant
Drug: etonogestrel implant
etonogestrel implant contraceptive

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

EFV 600mg q.d. with ENG
HIV-infected women 2-12 weeks postpartum who received efavirenz (EFV) 600mg q.d. postpartum and starting postpartum etonogestrel (ENG) implant
Drug: efavirenz
efavirenz 600 mg q.d.

Drug: etonogestrel implant
etonogestrel implant contraceptive




Primary Outcome Measures :
  1. PK Parameter: Area Under the Curve From 0 to 12 Hours (AUC12) With Median (IQR) for ARVs and TB Drugs [ 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. ]
    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.

  2. PK Parameter: Area Under the Curve From 0 to 12 Hours (AUC12) With Median (Range) for ARVs and TB Drugs [ 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. ]
    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.

  3. PK Parameter: Area Under the Curve From 0 to 12 Hours (AUC12) With Geometric Mean (95% CI) for ARVs and TB Drugs [ 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. ]
    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.

  4. PK Parameter: Area Under the Curve From 0 to 24 Hours (AUC24) With Median (IQR) for ARVs and TB Drugs [ 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. ]
    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.

  5. PK Parameter: Area Under the Curve From 0 to 24 Hours (AUC24) With Median (Range) for ARVs and TB Drugs [ 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. ]
    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.

  6. PK Parameter: Maximum Concentration (Cmax) in mg/L With Median (IQR) for ARVs and TB Drugs [ 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. ]
    Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods. Cmax was the maximum observed concentration after a dose.

  7. PK Parameter: Maximum Concentration (Cmax) in mg/L With Median (Range) for ARVs and TB Drugs [ 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. ]
    Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods. Cmax was the maximum observed concentration after a dose.

  8. PK Parameter: Maximum Concentration (Cmax) in ng/mL With Median (IQR) for ARVs and TB Drugs [ 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. ]
    Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods. Cmax was the maximum observed concentration after a dose.

  9. PK Parameter: Maximum Concentration (Cmax) in ng/mL With Median (95% CI) for ARVs and TB Drugs [ 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. ]
    Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods. Cmax was the maximum observed concentration after a dose.

  10. PK Parameter: Trough Concentration (C12) With Median (IQR) for ARVs and TB Drugs [ Time Frame: Measured at 2nd trimester (20-26 wks gestation); 3rd trimester (30-38 gestation); and either 2-3 wks, 2-8 wks, or 6-12 wks postpartum, depending on study arm. Trough concentration was measured 12 hrs after an observed dose. ]
    Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods. Trough concentration was the measured concentration from the 12h post-dose sample after an observed dose.

  11. PK Parameter: Trough Concentration (C12) With Median (Range) for ARVs and TB Drugs [ Time Frame: Measured at 2nd trimester (20-26 wks gestation); 3rd trimester (30-38 gestation); and either 2-3 wks, 2-8 wks, or 6-12 wks postpartum, depending on study arm. Trough concentration was measured 12 hrs after an observed dose. ]
    Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods. Trough concentration was the measured concentration from the 12h post-dose sample after an observed dose.

  12. PK Parameter: Trough Concentration (C12) With Geometric Mean (95% CI) for ARVs and TB Drugs [ 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. Trough concentration was measured 12 hrs after an observed dose. ]
    Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods. Trough concentration was the measured concentration from the 12h post-dose sample after an observed dose.

  13. PK Parameter: Trough Concentration (C24) With Median (IQR) for ARVs and TB Drugs [ 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. Trough concentration was measured 24 hrs after an observed dose. ]

    Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods. Trough concentration was the measured concentration from the 24h post-dose sample after an observed dose.

    For the TAF 25 mg q.d., 10 mg q.d. w/COBI, and 25 mg q.d. w/COBI or RTV boosting arms, samples were all below the limit of quantification and statistical analyses were not conducted.


  14. PK Parameter: Trough Concentration (C24) With Median (Range) for ARVs and TB Drugs [ 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. Trough concentration was measured 24 hrs after an observed dose. ]
    Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods. Trough concentration was the measured concentration from the 24h post-dose sample after an observed dose.

  15. Number of Women Who Met PK Target of Area Under the Curve (AUC) for ARVs [ 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. ]
    Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods. AUC (area under the curve) were determined using the linear trapezoidal rule. See PK target in the Protocol Appendix V.

  16. Number of Women Who Met PK Target of Maximum Concentration (Cmax) for First Line TB Drugs [ 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. ]

    Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods. Cmax was the maximum observed concentration after a dose. See PK target in Protocol Appendix V.

    No results are available for this outcome measure at this time. The TB drugs are being assayed in batches (not real-time) after the study completion. Labs have been experiencing additional delays due to urgent COVID-19 pandemic related work.


  17. Plasma Concentration for Contraceptives [ Time Frame: Measured at 6-7 weeks after contraceptive initiation postpartum ]
    Serum concentrations of the contraceptives. Note that no historical controls were provided by team pharmacologists and thus no comparisons were done for contraceptive concentrations in women using hormonal contraceptives and selected ARV drugs as compared to historical controls not using those ARV drugs.

  18. Area Under the Curve From 0 to 12 Hours (AUC12) of ARVs for Contraceptive Arms [ Time Frame: Measured at 2-12 wks postpartum before contraceptive initiation and 6-7 wks after contraceptive initiation. Blood samples were drawn pre-dose and at 0, 1, 2, 6, 8 and 12 hours post dosing. ]
    Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods. AUC12h (area-under-the-curve from 0 to 12 hours) were determined using the linear trapezoidal rule.

  19. Area Under the Curve From 0 to 24 Hours (AUC24) of ARVs for Contraceptive Arms [ Time Frame: Measured at 2-12 wks postpartum before contraceptive initiation and 6-7 wks after contraceptive initiation. Blood samples were drawn pre-dose and at 0, 1, 2, 6, 8, 12, and 24 hours post dosing. ]
    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 linear trapezoidal rule.


Secondary Outcome Measures :
  1. PK Parameter: Cord/Maternal Blood Concentration Ratio With Median (IQR) for ARVs and TB Drugs [ Time Frame: Measured at time of delivery with single cord blood and single maternal plasma sample. ]
    Cord blood and maternal plasma concentrations were collected and measured at delivery, and compared as a ratio.

  2. PK Parameter: Cord/Maternal Blood Concentration Ratio With Median (Range) for ARVs and TB Drugs [ Time Frame: Measured at time of delivery with single cord blood and single maternal plasma sample. ]
    Cord blood and maternal plasma concentrations were collected and measured at delivery, and compared as a ratio. For arms with zero overall participants analyzed, samples were below the limit of quantification and ratios could not be calculated.

  3. Pharmacokinetic (PK) Parameter: Infant Plasma Washout Half-life (T1/2) of ARVs and TB Drugs [ Time Frame: Infant plasma samples at 2-10, 18-28, 36-72 hours and 5-9 days after birth. ]
    Infant plasma concentrations were collected and measured during the first 9 days of life. Half-life is defined as 0.693/k, where k, the elimination rate constant, is the slope of the decline in concentrations.

  4. Pharmacokinetic (PK) Parameter: Infant Plasma Washout Concentration of ARVs and TB Drugs [ Time Frame: Blood samples were collected at 2-10, 18-28, 36-72 hours and 5-9 days after birth. ]
    Infant plasma concentrations were collected and measured during the first 9 days of life.


Other Outcome Measures:
  1. ARV Concentrations in Plasma [ Time Frame: Measured at intensive PK visit ]
    The original study protocol listed this PK parameter under primary outcome measures. However, this PK parameter was intended for potential supporting analyses and thus belong with Other outcome measures (see SAP).

  2. ARV Concentrations in Vaginal Secretions [ Time Frame: Measured at intensive PK visit ]
    The original study protocol listed this PK parameter under secondary outcome measures. However, this PK parameter was intended for potential supporting analyses and thus belongs with Other outcome measures (see SAP).

  3. Drug Parameter: Half-life (t1/2) [ Time Frame: Measured at intensive PK visit. Timing of intensive PK visit depends on participant's study arm; may occur during 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. ]
    The original study protocol listed this PK parameter under primary outcome measures. However, this PK parameter was intended for potential supporting analyses and thus belongs with Other outcome measures (see SAP).

  4. Drug Parameter: Volume of Distribution Over Systemic Availability (V/F) [ Time Frame: Measured at intensive PK visit. Timing of intensive PK visit depends on participant's study arm; may occur during 2nd trimester (20-26 wks gestation); 3rd trimester (30-38 wks gestation); and either 2-3 weeks, 2-8 wks, or 6-12 wks postpartum. ]
    The original study protocol listed this PK parameter under primary outcome measures. However, this PK parameter was intended for potential supporting analyses and thus belongs with Other outcome measures (see SAP).

  5. Drug Parameter: Clearance Over Systemic Availability (Cl/F) [ Time Frame: Measured at intensive PK visit. Timing of intensive PK visit depends on participant's study arm; may occur during 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. ]
    The original study protocol listed this PK parameter under primary outcome measures. However, this PK parameter was intended for potential supporting analyses and thus belongs with Other outcome measures (see SAP).

  6. Drug Parameter: Time After Administration of Drug When Maximum Plasma Concentration is Reached (Tmax) [ Time Frame: Measured at intensive PK visit. Timing of intensive PK visit depends on participant's study arm; may occur during 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. ]
    The original study protocol listed this PK parameter under primary outcome measures. However, this PK parameter was intended for potential supporting analyses and thus belongs with Other outcome measures (see SAP).

  7. Drug Parameter: Minimum Concentration (Cmin) [ Time Frame: Measured at intensive PK visit. Timing of intensive PK visit depends on participant's study arm; may occur during 2nd trimester (20-26 wks gestation); 3rd trimester (30-38 wks gestation); and either 2-3 weeks, 2-8 wks, or 6-12 wks postpartum. ]
    The original study protocol listed this PK parameter under primary outcome measures. However, this PK parameter was intended for potential supporting analyses and thus belongs with Other outcome measures (see SAP).

  8. Drug Parameter: Pre-dose Concentration (Cdose) [ Time Frame: Measured at intensive PK visit. Timing of intensive PK visit depends on participant's study arm; may occur during 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. ]
    The original study protocol listed this PK parameter under primary outcome measures. However, this PK parameter was intended for potential supporting analyses and thus belongs with Other outcome measures (see SAP).

  9. Adverse Events of Grade 3 or Higher [ Time Frame: Measured through 24 weeks postpartum ]

    The original study protocol listed all non-primary outcome measures under secondary outcome measures without distinguishing between secondary vs other outcome measures. This outcome measure was intended for potential supporting analyses which were not conducted (see SAP).

    See Adverse events section for adverse events.


  10. Infant Neurological Events of Grade 1 or Higher [ Time Frame: Measured through 24 weeks of life ]

    The original study protocol listed all non-primary outcome measures under secondary outcome measures without distinguishing between secondary vs other outcome measures. This outcome measure was intended for potential supporting analyses which were not conducted (see SAP).

    See Adverse events section for adverse events.


  11. Adverse Pregnancy Outcome: Preterm Birth [ Time Frame: Measured through delivery ]

    The original study protocol listed all non-primary outcome measures under secondary outcome measures without distinguishing between secondary vs other outcome measures. This outcome measure was intended for potential supporting analyses which were not conducted (see SAP).

    See Adverse events section for adverse events.


  12. Adverse Pregnancy Outcome: Low Birth Weight [ Time Frame: Measured at delivery ]

    The original study protocol listed all non-primary outcome measures under secondary outcome measures without distinguishing between secondary vs other outcome measures. This outcome measure was intended for potential supporting analyses which were not conducted (see SAP).

    See Adverse events section for adverse events.


  13. Adverse Pregnancy Outcome: Fetal Demise [ Time Frame: Measured through 24 weeks postpartum ]

    The original study protocol listed all non-primary outcome measures under secondary outcome measures without distinguishing between secondary vs other outcome measures. This outcome measure was intended for potential supporting analyses which were not conducted (see SAP).

    See Adverse events section for adverse events.


  14. Adverse Pregnancy Outcome: Congenital Anomalies [ Time Frame: Measured through 24 weeks of life ]

    The original study protocol listed all non-primary outcome measures under secondary outcome measures without distinguishing between secondary vs other outcome measures. This outcome measure was intended for potential supporting analyses which werenot conducted (see SAP).

    See Adverse events section for adverse events.


  15. Infant HIV Infection Status [ Time Frame: Measured through 24 weeks of life ]
    The original study protocol listed all non-primary outcome measures under secondary outcome measures without distinguishing between secondary vs other outcome measures. This outcome measure was intended for potential supporting analyses which were not conducted (see SAP).

  16. Ratio of Unbound/Total Drug Concentrations [ Time Frame: Measured at time of delivery ]
    The original study protocol listed all non-primary outcome measures under secondary outcome measures without distinguishing between secondary vs other outcome measures. This outcome measure was intended for potential supporting analyses which were not conducted (see SAP).

  17. Rate of Detection of Study Drugs in Vaginal Secretions [ Time Frame: Measured at intensive PK visit ]
    The original study protocol listed all non-primary outcome measures under secondary outcome measures without distinguishing between secondary vs other outcome measures. This outcome measure was intended for potential supporting analyses which were not conducted (see SAP).

  18. Ratio of Vaginal Drug Concentrations to Simultaneous Blood Concentrations [ Time Frame: Measured at intensive PK visit ]
    The original study protocol listed all non-primary outcome measures under secondary outcome measures without distinguishing between secondary vs other outcome measures. This outcome measure was intended for potential supporting analyses which were not conducted (see SAP).

  19. Rate of Detection of HIV RNA/DNA in Vaginal Secretions and Comparison to Level in Blood [ Time Frame: Measured at intensive PK visit ]
    The original study protocol listed all non-primary outcome measures under secondary outcome measures without distinguishing between secondary vs other outcome measures. This outcome measure was intended for potential supporting analyses which were not conducted (see SAP).

  20. ARV Exposure (as Measured by Area Under the Curve or Other PK Parameters) During Pregnancy and Postpartum According to Genotype [ Time Frame: Measured at intensive PK visit ]
    The original study protocol listed all non-primary outcome measures under secondary outcome measures without distinguishing between secondary vs other outcome measures. This outcome measure was intended for potential supporting analyses which were not conducted (see SAP).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Pregnant and postpartum women from IMPAACT US and non-US sites receiving the medicines specified in the protocol as part of clinical care and infants born to those women enrolled during pregnancy.
Criteria

Maternal Inclusion Criteria:

  • Participant must belong to one of the following 5 groups:

    1. HIV-infected pregnant women greater than or equal to 20 weeks gestation NOT on TB treatment receiving one or more of the ARV drugs/drug combinations specified in the protocol
    2. HIV-infected pregnant women greater than or equal to 20 weeks gestation receiving one of the ARV drugs/drug combinations specified in the protocol and TB treatment with at least one of the TB drugs, specified in the protocol, at study entry
    3. HIV-uninfected pregnant women greater than or equal to 20 weeks gestation receiving at least two of the first-line TB drugs, specified in the protocol, at study entry
    4. HIV-infected and HIV-uninfected pregnant women greater than or equal to 20 weeks gestation receiving at least two of the second-line TB drugs, specified in the protocol, at study entry
    5. HIV-infected women 2 to 12 weeks (14 to 84 days) post-delivery receiving one of the ARV drug combinations listed in the protocol AND starting postpartum contraceptives as listed in the protocol
  • The woman must be stable on the ARV drug/drug combination and/or TB drug combination for at least 2 weeks prior to PK sampling
  • If a woman is receiving a specific generic ARV formulation, the protocol team has approved this formulation
  • HIV-infected pregnant women must be planning to continue on current ARV regimen until postpartum PK sampling is completed. HIV-infected postpartum women on hormonal contraceptives must be planning to continue on ARV and contraceptive regimens until final PK sampling is completed
  • For HIV-infected women: confirmed HIV infection, documented by positive results from two samples collected at different time points prior to study entry. More information on this criterion can be found in the protocol.
  • HIV-uninfected pregnant women must have documented negative HIV antibody test during current pregnancy. Note: adequate source documentation, including the date of specimen collection, date of testing, test performed, and test result, must be available.
  • Participants enrolling in the 3rd trimester must enroll by 37 6/7 weeks gestation
  • Participant can provide legal informed consent per local regulations
  • If a woman has completed this study and becomes pregnant again, she may re-enroll in the study only if she is enrolled in a different arm than that studied during her initial enrollment

Maternal Exclusion Criteria:

  • Women on medicines known to interfere with absorption, metabolism, or clearance of the drug being evaluated (see protocol for more information). Rifampicin is permitted for women being evaluated for TB and ARV drug interactions
  • If pregnant, carrying multiple fetuses
  • Clinical or laboratory toxicity that, in the opinion of the site investigator, would be likely to require a change in the medicine regimen during the period of study

Infant Enrollment Criteria:

- All infants of mothers enrolled during pregnancy (meeting criteria specified above) are enrolled, in utero, immediately after maternal enrollment.

Infant Requirements for Washout Pharmacokinetic Sampling:

  • Born to HIV-infected mother enrolled during pregnancy in an ARV arm (does not include infants born to HIV-uninfected mothers receiving TB drugs)
  • Birth weight greater than 1000 grams
  • Is NOT receiving disallowed medications described in Section 7 of the protocol
  • Does not have any severe congenital malformation or other medical condition not compatible with life or that would interfere with study participation or interpretation, as judged by the site investigator
  • Born after singleton delivery (not after multiple birth)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00042289


Locations
Show Show 62 study locations
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
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Study Chair: Mark Mirochnick, MD Boston Medical Center
  Study Documents (Full-Text)

Documents provided by National Institute of Allergy and Infectious Diseases (NIAID):
Statistical Analysis Plan: PK SAP  [PDF] July 27, 2021
Statistical Analysis Plan: Primary SAP  [PDF] September 13, 2021
Informed Consent Form  [PDF] February 2, 2016

Additional Information:
Publications of Results:

Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00042289    
Other Study ID Numbers: P1026s
10040 ( Registry Identifier: DAIDS ES )
IMPAACT P1026s
First Posted: August 1, 2002    Key Record Dates
Results First Posted: July 22, 2022
Last Update Posted: July 22, 2022
Last Verified: June 2022
Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Pregnancy
Pharmacokinetics
Treatment Experienced
Additional relevant MeSH terms:
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HIV Infections
Blood-Borne Infections
Communicable Diseases
Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Ritonavir
Lopinavir
Atazanavir Sulfate
Darunavir
Nelfinavir
Indinavir
Fosamprenavir
Amprenavir
Tenofovir
Emtricitabine
Raltegravir Potassium
Nevirapine
Maraviroc
Dolutegravir
Abacavir
Didanosine
Cobicistat
Rilpivirine