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Trial record 1 of 2 for:    15627034 [PUBMED-IDS]
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Reducing the Incidence of Nevirapine Resistance Mutations in Pregnant HIV Infected Women Who Receive Anti-HIV Drugs Prior to and After Giving Birth

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ClinicalTrials.gov Identifier: NCT00109590
Recruitment Status : Completed
First Posted : May 2, 2005
Results First Posted : November 6, 2012
Last Update Posted : January 13, 2015
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 Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition HIV Infections
Interventions Drug: Didanosine, enteric-coated
Drug: Lopinavir/ritonavir
Drug: Nevirapine
Drug: Zidovudine
Enrollment 175

Recruitment Details Study participants were enrolled at seven IMPAACT affiliated sites in Thailand. Between June 9, 2006 and June 30, 2008, 175 participants enrolled in the study.
Pre-assignment Details The study recruited HIV infected pregnant women who were >= 18 years of age,>=28 to <38 weeks gestation, who did not plan to start antiretroviral treatment within eight weeks following delivery, not planning to breastfeed and had CD4+ count >250 cells/mm3. Women were randomized in approximately equal numbers to one of three treatment arms.
Arm/Group Title Arm A : LPV/r x 7d Arm B : no LPV/r Arm C: LPV/r x 30d
Hide Arm/Group Description Nevirapine (NVP) 200 mg orally, single dose at onset of labor, Zidovudine (ZDV) 300 mg orally at onset of labor, every 3 hours during labor and twice daily for 7 days postpartum, didanosine (ddI) 250 mg orally (if body weight <60 kg) or 400 mg orally daily (if body weight >= 60 kg) at the onset of labor, during labor, and for 7 days postpartum, > Lopinavir/Ritonavir (LPV/r) 400/100mg orally twice daily at the onset of labor, during labor and for 7 days postpartum. Neviarpine (NVP) 200 mg orally, single dose at onset of labor, Zidovudine (ZDV) 300 mg orally at onset of labor, every 3 hours during labor and twice daily for 30 days postpartum, didanosine (ddI) 250 mg orally (if body weight <60 kg) or 400 mg orally once daily (if body weight >= 60 kg) at the onset of labor, during labor, and for 30 days postpartum. Nevirapine (NVP) 200 mg orally, single dose at onset of labor, Zidovudine (ZDV) 300 mg orally at onset of labor, every 3 hours during labor and twice daily for 30 days postpartum, didanosine (ddI) 250 mg orally (if body weight <60 kg) or 400 mg orally daily (if body weight >= 60 kg) at the onset of labor, during labor, and for 30 days postpartum, Lopinavir/Ritonavir (LPV/r) 400/100mg orally twice daily at the onset of labor, during labor and for 30 days postpartum.
Period Title: Overall Study
Started 57 58 60
RECEIVED TREATMENT 56 56 57
Completed 55 56 56
Not Completed 2 2 4
Reason Not Completed
Lost to Follow-up             1             0             1
Never Started Treatment             1             2             3
Arm/Group Title Arm A : LPV/r x 7d Arm B : no LPV/r Arm C: LPV/r x 30d Total
Hide Arm/Group Description NVP 200 mg orally, single dose at onset of labor, ZDV 300 mg orally at onset of labor, every 3 hours during labor and twice daily for 7 days postpartum, ddI 250 mg orally (if body weight <60 kg) or 400 mg orally daily (if body weight >= 60 kg) at the onset of labor, during labor, and for 7 days postpartum, LPV/r 400/100mg orally twice daily at the onset of labor, during labor and for 7 days postpartum. NVP 200 mg orally, single dose at onset of labor, ZDV 300 mg orally at onset of labor, every 3 hours during labor and twice daily for 30 days postpartum, ddI 250 mg orally (if body weight <60 kg) or 400 mg orally daily (if body weight >= 60 kg) at the onset of labor, during labor, and for 30 days postpartum. NVP 200 mg orally, single dose at onset of labor, ZDV 300 mg orally at onset of labor, evry 3 hours during labor and twice daily for 30 days postpartum, ddI 250 mg orally (if body weight <60 kg) or 400 mg orally daily (if body weight >= 60 kg) at the onset of labor, during labor, and for 30 days postpartum, LPV/r 400/100mg orally twice daily at the onset of labor, during labor and for 30 days postpartum. Total of all reporting groups
Overall Number of Baseline Participants 56 56 57 169
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 56 participants 56 participants 57 participants 169 participants
27  (6) 28  (5) 27  (5) 28  (5)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 56 participants 56 participants 57 participants 169 participants
18 to < 30years 34 35 38 107
>=30 to < 45 years 21 21 19 61
>= 45 years 1 0 0 1
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 56 participants 56 participants 57 participants 169 participants
Female
56
 100.0%
56
 100.0%
57
 100.0%
169
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Gestational Age at Entry  
Median (Full Range)
Unit of measure:  Weeks
Number Analyzed 56 participants 56 participants 57 participants 169 participants
32
(28 to 37)
31
(27 to 38)
31
(28 to 37)
31
(27 to 38)
Duration of ZDV during pregnancy - At Entry  
Median (Full Range)
Unit of measure:  Weeks
Number Analyzed 56 participants 56 participants 57 participants 169 participants
3
(0 to 9)
2
(0 to 10)
2
(0 to 27)
3
(0 to 27)
Duration of ZDV during pregnancy - At Delivery  
Median (Full Range)
Unit of measure:  Weeks
Number Analyzed 56 participants 56 participants 57 participants 169 participants
10
(2 to 16)
11
(5 to 18)
10
(0 to 31)
10
(0 to 31)
CD4 cell count at entry  
Median (Full Range)
Unit of measure:  cells/uL
Number Analyzed 56 participants 56 participants 57 participants 169 participants
431
(262 to 1233)
413
(251 to 1024)
481
(262 to 1183)
456
(251 to 1233)
CD4 cell count at delivery  
Median (Full Range)
Unit of measure:  cells/uL
Number Analyzed 56 participants 56 participants 57 participants 169 participants
484
(70 to 1001)
517
(198 to 1150)
566
(222 to 1182)
513
(70 to 1182)
Plasma HIV RNA at entry  
Median (Full Range)
Unit of measure:  Log10 copies/mL
Number Analyzed 56 participants 56 participants 57 participants 169 participants
3.48
(2.60 to 4.98)
3.52
(1.00 to 4.99)
3.54
(2.60 to 5.05)
3.49
(1.00 to 5.05)
Plasma HIV-RNA at delivery  
Median (Full Range)
Unit of measure:  Log10 copies/mL
Number Analyzed 56 participants 56 participants 57 participants 169 participants
3.63
(1.70 to 4.90)
3.36
(1.70 to 4.83)
3.48
(1.70 to 4.71)
3.48
(1.70 to 4.90)
1.Primary Outcome
Title The Proportion of Women Who Develop One or More New NVP Resistance Mutations as Identified by Consensus Sequencing or Oligonucleotide Ligation Assay in Plasma (Sampling Was Done at Days 10,21,30, and Weeks 5,6, and 8 Postpartum).
Hide Description The incidence of new NVP resistance mutation in plasma HIV within 8 weeks postpartum in each randomized arm was estimated using an exact binomial confidence interval. If a resistance mutation was detected at any of the timepoints then an endpoint was met. Samples with VL <500 copies/mL were considered free of mutations. If a resistance result was missing for reasons other than VL <500 copies/ml (e.g.missed visit), it was conservatively imputed as resistant in the primary analysis.
Time Frame within 8 weeks postpartum.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All women who started treatment were included in an intention-to-treat analysis.
Arm/Group Title Arm A : LPV/r x 7d Arm B : no LPV/r Arm C: LPV/r x 30d
Hide Arm/Group Description:
NVP 200 mg orally, single dose at onset of labor, ZDV 300 mg orally at onset of labor, every 3 hours during labor and twice daily for 7 days postpartum ddI 250 mg orally (if body weight <60 kg) or 400 mg orally daily (if body weight >= 60 kg) at the onset of labor, during labor, and for 7 days postpartum, LPV/r 400/100mg orally twice daily at the onset of labor, during labor and for 7 days postpartum.
NVP 200 mg orally, single dose at onset of labor, ZDV 300 mg orally at onset of labor, q3h during labor and twice daily for 30 days postpartum, ddI 250 mg orally (if body weight <60 kg) or 400 mg orally daily (if body weight >= 60 kg) at the onset of labor, during labor, and for 30 days postpartum.
NVP 200 mg orally, single dose at onset of labor,ZDV 300 mg orally at onset of labor, evry 3 hours during labor and twice daily for 30 days postpartum, ddI 250 mg orally (if body weight <60 kg) or 400 mg orally daily (if body weight >= 60 kg) at the onset of labor, during labor, and for 30 days postpartum, LPV/r 400/100mg orally twice daily at the onset of labor, during labor and for 30 days postpartum.
Overall Number of Participants Analyzed 56 56 57
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percent of participants
7.1
(2.0 to 17.3)
12.5
(5.2 to 24.1)
5.3
(1.1 to 14.6)
2.Primary Outcome
Title The Proportion of Women in Each Randomized Arm Who Have One or More New NVP Resistance Mutations as Identified by Consensus Sequencing or Oligonucleotide Ligation Assay (OLA) in Plasma
Hide Description The incidence of new NVP resistance mutations at day 10 or week 6 postpartum in each randomized arm. Samples with viral load <500 copies/mL were considered free of mutations. If a resistance result was missing for reasons other than VL <500 copies/ml it was conservatively imputed as resistant in the primary analysis.
Time Frame at Day 10 or Week 6 postpartum.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All women who started treatment were included in an intention-to-treat analysis (according to randomized treatment assignment, regardless of compliance with the protocol)
Arm/Group Title Arm A : LPV/r x 7d Arm B : no LPV/r Arm C : LPV/r x 30d
Hide Arm/Group Description:
NVP 200 mg orally, single dose at onset of labor, ZDV 300 mg orally at onset of labor, every 3 hours during labor and twice daily for 7 days postpartum, ddI 250 mg orally (if body weight <60 kg) or 400 mg orally daily (if body weight >= 60 kg) at the onset of labor, during labor, and for 7 days postpartum, LPV/r 400/100mg orally twice daily at the onset of labor, during labor and for 7 days postpartum.
NVP 200 mg orally, single dose at onset of labor, ZDV 300 mg orally at onset of labor, every 3 hours during labor and twice daily for 30 days postpartum, ddI 250 mg orally (if body weight <60 kg) or 400 mg orally daily (if body weight >= 60 kg) at the onset of labor, during labor, and for 30 days postpartum.
NVP 200 mg orally, single dose at onset of labor, ZDV 300 mg orally at onset of labor, every 3 hours during labor and twice daily for 30 days postpartum, ddI 250 mg orally (if body weight <60 kg) or 400 mg orally daily (if body weight >= 60 kg) at the onset of labor, during labor, and for 30 days postpartum, LPV/r 400/100mg orally twice daily at the onset of labor, during labor and for 30 days postpartum.
Overall Number of Participants Analyzed 56 56 57
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percent of participants
3.6
(0.5 to 12.3)
7.1
(2.0 to 17.3)
5.3
(1.1 to 14.6)
3.Primary Outcome
Title Area Under the Curve Pharmacokinetic Outcome for LPV/r. (AUC ug*hr/mL)
Hide Description Data was analyzed with WinNonLin (Version 5.2, Pharsight, USA) using non-compartmental methods. The pharmacokinetic parameters were calculated using the linear-trapezoidal rule. Cpredose and C4hour at the two measurement times were compared within-subject using the Wilcoxon signed-rank test.
Time Frame Within 72 hours postpartum and during the first 30 days postpartum
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
18 women were enrolled in this sub study,PK sampling was not performed in 2 women. Of the remaining 16 women, all completed the LPV/r PK sampling within 72 hours after delivery and at day 30 postpartum and had evaluable PK within 72 hours delivery but only 14 women had evaluable PK results at day 30 postpartum due to suspected poor drug adherence.
Arm/Group Title Within 72 Hrs Ppm At Day 30 Ppm
Hide Arm/Group Description:
ZDV, ddI, LPV/r x 30d
ZDV, ddI, LPV/r x 30d
Overall Number of Participants Analyzed 16 14
Median (Full Range)
Unit of Measure: ug*hr/mL
99.7
(66.3 to 180.5)
NA [1] 
(NA to NA)
[1]
Only 3 samples were collected at 30 days postpartum for PK assessment (pre-dose, 2 hours and 4 hours post-dose) and with these limited number of samples it was not possible to have a good estimate of the AUC and Cmax.
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Within 72 Hrs Ppm, At Day 30 Ppm
Comments The null hypothesis was that there was no difference in within-subject Cpredose LPV/r plasma drug concentrations within 72 hours after delivery versus at 30 days postpartum.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.009
Comments The p-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was two-sided P<0.05.
Method wilcoxon Signed Rank Test
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Within 72 Hrs Ppm, At Day 30 Ppm
Comments The null hypothesis was that there was no difference in within-subject C4hour LPV/r plasma drug concentrations within 72 hours after delivery versus at 30 days postpartum
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.048
Comments The p-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was two-sided P<0.05.
Method Wilcoxon Signed Rank Test
Comments [Not Specified]
4.Primary Outcome
Title Maximum Concentration Pharmacokinetic Outcome for LPV/r (Cmax ug/mL) .
Hide Description Data was analyzed with WinNonLin (Version 5.2, Pharsight, USA) using non-compartmental methods. The pharmacokinetic parameters were calculated using the linear-trapezoidal rule. Cpredose and C4hour at the two measurement times were compared within-subject using the Wilcoxon signed-rank test.
Time Frame Within 72 hours postpartum and during the first 30 days postpartum
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
18 women were enrolled in this sub study,PK sampling was not performed in 2 women. Of the remaining 16 women, all completed the LPV/r PK sampling within 72 hours after delivery and at day 30 postpartum and had evaluable PK within 72 hours delivery but only 14 women had evaluable PK results at day 30 postpartum due to suspected poor drug adherence.
Arm/Group Title Within 72 Hrs Ppm At Day 30 Ppm
Hide Arm/Group Description:
ZDV, ddI, LPV/r x 30d
ZDV, ddI, LPV/r x 30d
Overall Number of Participants Analyzed 16 14
Median (Full Range)
Unit of Measure: ug/mL
11.2
(8.0 to 17.5)
NA [1] 
(NA to NA)
[1]
Only 3 samples were collected at 30 days postpartum for PK assessment (pre-dose, 2 hours and 4 hours post-dose) and with these limited number of samples it was not possible to have a good estimate of the Cmax.
5.Primary Outcome
Title Pre-dose Concentration Pharmacokinetic Outcome for LPV/r (Cpredose ug/mL).
Hide Description Data was analyzed with WinNonLin (Version 5.2, Pharsight, USA) using non-compartmental methods. The pharmacokinetic parameters were calculated using the linear-trapezoidal rule. Cpredose and C4hour at the two measurement times were compared within-subject using the Wilcoxon signed-rank test.
Time Frame Within 72 hours postpartum and during the first 30 days postpartum
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
18 women were enrolled in this sub study,PK sampling was not performed in 2 women. Of the remaining 16 women, all completed the LPV/r PK sampling within 72 hours after delivery and at day 30 postpartum and had evaluable PK within 72 hours delivery but only 14 women had evaluable PK results at day 30 postpartum due to suspected poor drug adherence.
Arm/Group Title Within 72 Hrs Ppm At Day 30 Ppm
Hide Arm/Group Description:
ZDV, ddI, LPV/r x 30d
ZDV, ddI, LPV/r x 30d
Overall Number of Participants Analyzed 16 14
Median (Full Range)
Unit of Measure: ug/mL
6.08
(2.34 to 13.64)
9.17
(5.28 to 14.97)
6.Primary Outcome
Title Four (4) Hour Concentration Pharmacokinetic Outcome for LPV/r (C4hour ug/mL).
Hide Description Data was analyzed with WinNonLin (Version 5.2, Pharsight, USA) using non-compartmental methods. The pharmacokinetic parameters were calculated using the linear-trapezoidal rule. Cpredose and C4hour at the two measurement times were compared within-subject using the Wilcoxon signed-rank test.
Time Frame Within 72 hours postpartum and during the first 30 days postpartum
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
18 women were enrolled in this sub study,PK sampling was not performed in 2 women. Of the remaining 16 women, all completed the LPV/r PK sampling within 72 hours after delivery and at day 30 postpartum and had evaluable PK within 72 hours delivery but only 14 women had evaluable PK results at day 30 postpartum due to suspected poor drug adherence.
Arm/Group Title Within 72 Hrs Ppm At Day 30 Ppm
Hide Arm/Group Description:
ZDV, ddI, LPV/r x 30d
ZDV, ddI, LPV/r x 30d
Overall Number of Participants Analyzed 16 14
Median (Full Range)
Unit of Measure: ug/mL
10.78
(8.01 to 16.72)
12.96
(8.78 to 21.37)
7.Secondary Outcome
Title The Proportion of Women in Each Randomized Arm Who Have One or More New NVP Resistance Mutations for the Subgroup of Women With Plasma HIV RNA >= 500 Copies/ml At Entry
Hide Description The incidence of new NVP resistance mutations at day 10 or week 6 postpartum in each randomized arm. Samples with viral load <500 copies/mL were considered free of mutations. If a resistance result was missing for reasons other than VL <500 copies/ml it was conservatively imputed as resistant in the primary analysis.
Time Frame at Day 10 or Week 6 postpartum.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Includes only the Subgroup of women with Plasma HIV RNA >= 500 copies/ml at Entry and who started treatment; analyzed using the intention-to-treat principle (according to assigned treatment, regardless of compliance with the protocol).
Arm/Group Title Arm A: LPV/r x 7d Arm B: no LPV/r Arm C : LPV/r x 30d
Hide Arm/Group Description:
NVP 200 mg orally, single dose at onset of labor, ZDV 300 mg orally at onset of labor, every 3 hours during labor and twice daily for 7 days postpartum, ddI 250 mg orally (if body weight <60 kg) or 400 mg orally daily (if body weight >= 60 kg) at the onset of labor, during labor, and for 7 days postpartum, LPV/r 400/100mg orally twice daily at the onset of labor, during labor and for 7days postpartum.
NVP 200 mg orally, single dose at onset of labor, ZDV 300 mg orally at onset of labor, every 3 hours during labor and twice daily for 30 days postpartum, ddI 250 mg orally (if body weight <60 kg) or 400 mg orally daily (if body weight >= 60 kg) at the onset of labor, during labor, and for 30 days postpartum.
NVP 200 mg orally, single dose at onset of labor, ZDV 300 mg orally at onset of labor, q3h during labor and twice daily for 30 days postpartum, ddI 250 mg orally (if body weight <60 kg) or 400 mg orally daily (if body weight >= 60 kg) at the onset of labor, during labor, and for 30 days postpartum, LPV/r 400/100mg orally twice daily at the onset of labor, during labor and for 30 days postpartum.
Overall Number of Participants Analyzed 41 42 43
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percent of participants
4.9
(0.6 to 16.6)
9.5
(2.7 to 22.6)
7.0
(1.5 to 19.1)
8.Secondary Outcome
Title The Proportion of Women With Any New ZDV, ddI, or LPV/r Resistance Mutations.
Hide Description [Not Specified]
Time Frame At Week 5 postpartum (ZDV) and at the first timepoint with viral load >=500 copies/ml after treatment discontinuation (ddI and LPV/r).
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All women who started treatment were included in an intention-to-treat analysis
Arm/Group Title Arm A : LPV/r x 7d Arm B : no LPV/r Arm C: LPV/r x 30d
Hide Arm/Group Description:
NVP 200 mg orally, single dose at onset of labor, ZDV 300 mg orally at onset of labor, every 3 hours during labor and twice daily for 7 days postpartum, ddI 250 mg orally (if body weight <60 kg) or 400 mg orally daily (if body weight >= 60 kg) at the onset of labor, during labor, and for 7 days postpartum, LPV/r 400/100mg orally twice daily at the onset of labor, during labor and for 7 days postpartum.
NVP 200 mg orally, single dose at onset of labor, ZDV 300 mg orally at onset of labor, q3h during labor and twice daily for 30 days postpartum, ddI 250 mg orally (if body weight <60 kg) or 400 mg orally daily (if body weight >= 60 kg) at the onset of labor, during labor, and for 30 days postpartum.
NVP 200 mg orally, single dose at onset of labor, ZDV 300 mg orally at onset of labor, every 3 hours during labor and twice daily for 30 days postpartum, ddI 250 mg orally (if body weight <60 kg) or 400 mg orally daily (if body weight >= 60 kg) at the onset of labor, during labor, and for 30 days postpartum, LPV/r 400/100mg orally twice daily at the onset of labor, during labor and for 30 days postpartum.
Overall Number of Participants Analyzed 56 56 57
Measure Type: Number
Unit of Measure: percent of participants
The proportion of women with new ZDV resistance 0 1.78 0
The proportion of women with new ddI resistance 0 0 0
The proportion of women with new LPV/r resistance 0 0 0
9.Secondary Outcome
Title Number of Women With Grade >=3 Events After Start of Study Treatment
Hide Description Adverse events were graded using the Division of AIDS (DAIDS) Table for Grading > the Severity of Adult and Pediatric Adverse Events (December 2004). All grade 3 and higher signs, symptoms, and laboratory toxicities (and events of any grade that led to a change in study treatment) were included.
Time Frame After start of study Treatment (postpartum)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All women who started treatment were included in an intention-to-treat analysis.
Arm/Group Title Arm A : LPV/r x 7d Arm B : no LPV/r Arm C: LPV/r x 30d
Hide Arm/Group Description:
NVP 200 mg orally, single dose at onset of labor, ZDV 300 mg orally at onset of labor, every 3 hours during labor and twice daily for 7 days postpartum, ddI 250 mg orally (if body weight <60 kg) or 400 mg orally daily (if body weight >= 60 kg) at the onset of labor, during labor, and for 7 days postpartum, LPV/r 400/100mg orally twice daily at the onset of labor, during labor and for 7 days postpartum.
NVP 200 mg orally, single dose at onset of labor, ZDV 300 mg orally at onset of labor, every 3 hours during labor and twice daily for 30 days postpartum, ddI 250 mg orally (if body weight <60 kg) or 400 mg orally daily (if body weight >= 60 kg) at the onset of labor, during labor, and for 30 days postpartum.
NVP 200 mg orally, single dose at onset of labor, ZDV 300 mg orally at onset of labor, every 3 hours during labor and twice daily for 30 days postpartum, ddI 250 mg orally (if body weight <60 kg) or 400 mg orally daily (if body weight >= 60 kg) at the onset of labor, during labor, and for 30 days postpartum, LPV/r 400/100mg orally twice daily at the onset of labor, during labor and for 30 days postpartum.
Overall Number of Participants Analyzed 56 56 57
Measure Type: Number
Unit of Measure: participants
2 0 2
10.Secondary Outcome
Title Proportion of Women With New NVP Resistance Mutation Within 8 Weeks Postpartum Who Had a NVP Resistance Mutation Detected at 72 Weeks Postpartum.
Hide Description Resistance mutations as identified by OLA in plasma samples or PBMC at 72 weeks postpartum amongst women who had new NVP resistance mutations within 8 weeks postpatrum. These results were based on the 13 women who developed a new NVP resistance mutation in the first 8 weeks postpartum. For the primary outcome measure 1, one particpant in arm A was unavailable for follow-up after week 5 and was conservatively imputed to have developed resistance mutation.
Time Frame within 72 weeks postpartum
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
amongst the participants who developed resistance within 8 weeks postpartum
Arm/Group Title Arm A : LPV/r x 7d Arm B : no LPV/r Arm C: LPV/r x 30d
Hide Arm/Group Description:
NVP 200 mg orally, single dose at onset of labor, ZDV 300 mg orally at onset of labor, every 3 hours during labor and twice daily for 7 days postpartum, ddI 250 mg orally (if body weight <60 kg) or 400 mg orally daily (if body weight >= 60 kg) at the onset of labor, during labor, and for 7 days postpartum, LPV/r 400/100mg orally twice daily at the onset of labor, during labor and for 7 days postpartum.
NVP 200 mg orally, single dose at onset of labor, ZDV 300 mg orally at onset of labor, every 3 hours during labor and twice daily for 30 days postpartum, ddI 250 mg orally (if body weight <60 kg) or 400 mg orally daily (if body weight >= 60 kg) at the onset of labor, during labor, and for 30 days postpartum.
NVP 200 mg orally, single dose at onset of labor, ZDV 300 mg orally at onset of labor, every 3 hours during labor and twice daily for 30 days postpartum, ddI 250 mg orally (if body weight <60 kg) or 400 mg orally daily (if body weight >= 60 kg) at the onset of labor, during labor, and for 30 days postpartum, LPV/r 400/100mg orally twice daily at the onset of labor, during labor and for 30 days postpartum.
Overall Number of Participants Analyzed 3 7 3
Measure Type: Number
Unit of Measure: participants
OLA in plasma samples 0 0 0
OLA in PBMC 0 0 1
11.Secondary Outcome
Title Resistance Mutations in HIV Infected Infants
Hide Description Resistance mutations as identified by consensus sequencing or OLA
Time Frame 24 weeks postpartum
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Amongst the infants who became HIV-infected.
Arm/Group Title Arm A : LPV/r x 7d Arm B : no LPV/r Arm C: LPV/r x 30d
Hide Arm/Group Description:
NVP 200 mg orally, single dose at onset of labor, ZDV 300 mg orally at onset of labor, every 3 hours during labor and twice daily for 7 days postpartum, ddI 250 mg orally (if body weight <60 kg) or 400 mg orally daily (if body weight >= 60 kg) at the onset of labor, during labor, and for 7 days postpartum, LPV/r 400/100mg orally twice daily at the onset of labor, during labor and for 7 days postpartum.
NVP 200 mg orally, single dose at onset of labor, ZDV 300 mg orally at onset of labor, every 3 hours during labor and twice daily for 30 days postpartum, ddI 250 mg orally (if body weight <60 kg) or 400 mg orally daily (if body weight >= 60 kg) at the onset of labor, during labor, and for 30 days postpartum.
NVP 200 mg orally, single dose at onset of labor, ZDV 300 mg orally at onset of labor, evry 3 hours during labor and twice daily for 30 days postpartum, ddI 250 mg orally (if body weight <60 kg) or 400 mg orally daily (if body weight >= 60 kg) at the onset of labor, during labor, and for 30 days postpartum, LPV/r 400/100mg orally twice daily at the onset of labor, during labor and for 30 days postpartum.
Overall Number of Participants Analyzed 0 1 1
Measure Type: Number
Unit of Measure: participants
0 0
12.Secondary Outcome
Title Median Viral Load (log10 Copies/ml) at 24 Weeks Postpartum in Women
Hide Description [Not Specified]
Time Frame at 24 weeks postpartum
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The number of particpants included in this analyses were for those for whom viral loads were available at 24 weeeks postpartum.
Arm/Group Title Arm A : LPV/r x 7d Arm B : no LPV/r Arm C: LPV/r x 30d
Hide Arm/Group Description:
NVP 200 mg orally, single dose at onset of labor, ZDV 300 mg orally at onset of labor, every 3 hours during labor and twice daily for 7 days postpartum, ddI 250 mg orally (if body weight <60 kg) or 400 mg orally QD (if body weight >= 60 kg) at the onset of labor, during labor, and for 7 days postpartum, LPV/r 400/100mg orally twice daily at the onset of labor, during labor and for 7 days postpartum.
NVP 200 mg orally, single dose at onset of labor, ZDV 300 mg orally at onset of labor, every 3 hours during labor and twice daily for 30 days postpartum, ddI 250 mg orally (if body weight <60 kg) or 400 mg orally daily (if body weight >= 60 kg) at the onset of labor, during labor, and for 30 days postpartum.
NVP 200 mg orally, single dose at onset of labor, ZDV 300 mg orally at onset of labor, every 3 hours during labor and twice daily for 30 days postpartum, ddI 250 mg orally (if body weight <60 kg) or 400 mg orally daily (if body weight >= 60 kg) at the onset of labor, during labor, and for 30 days postpartum, LPV/r 400/100mg orally twice daily at the onset of labor, during labor and for 30 days postpartum.
Overall Number of Participants Analyzed 54 55 54
Median (Full Range)
Unit of Measure: participants
4.3
(1.7 to 5.7)
3.9
(1.7 to 5.3)
4.0
(1.7 to 5.2)
Time Frame Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason.
Adverse Event Reporting Description Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade >=3 for mothers or grade >=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).
 
Arm/Group Title Mother: LPV/r x 7d Mother: no LPV/r Mother: LPV/r x 30d Infant: LPV/r x 7d Infant: no LPV/r Infant: LPV/r x 30d
Hide Arm/Group Description NVP 200 mg orally, single dose at onset ZDV & ddI x 30d ZDV, ddI, LPV/r x 30d NVP 200 mg orally, single dose at onset ZDV & ddI x 30d ZDV, ddI, LPV/r x 30d
All-Cause Mortality
Mother: LPV/r x 7d Mother: no LPV/r Mother: LPV/r x 30d Infant: LPV/r x 7d Infant: no LPV/r Infant: LPV/r x 30d
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Mother: LPV/r x 7d Mother: no LPV/r Mother: LPV/r x 30d Infant: LPV/r x 7d Infant: no LPV/r Infant: LPV/r x 30d
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/56 (0.00%)   1/56 (1.79%)   2/57 (3.51%)   34/56 (60.71%)   32/57 (56.14%)   33/57 (57.89%) 
Blood and lymphatic system disorders             
Anaemia  1  0/56 (0.00%)  0/56 (0.00%)  2/57 (3.51%)  17/56 (30.36%)  8/57 (14.04%)  10/57 (17.54%) 
Neutropenia  1  0/56 (0.00%)  0/56 (0.00%)  0/57 (0.00%)  2/56 (3.57%)  4/57 (7.02%)  1/57 (1.75%) 
Neutropenia neonatal  1  0/56 (0.00%)  0/56 (0.00%)  0/57 (0.00%)  1/56 (1.79%)  0/57 (0.00%)  0/57 (0.00%) 
Thrombocytopenia  1  0/56 (0.00%)  0/56 (0.00%)  0/57 (0.00%)  2/56 (3.57%)  1/57 (1.75%)  1/57 (1.75%) 
Congenital, familial and genetic disorders             
ABO haemolytic disease of newborn  1  0/56 (0.00%)  0/56 (0.00%)  0/57 (0.00%)  0/56 (0.00%)  1/57 (1.75%)  0/57 (0.00%) 
Congenital hypothyroidism  1  0/56 (0.00%)  0/56 (0.00%)  0/57 (0.00%)  1/56 (1.79%)  0/57 (0.00%)  0/57 (0.00%) 
Fallot's tetralogy  1  0/56 (0.00%)  0/56 (0.00%)  0/57 (0.00%)  0/56 (0.00%)  0/57 (0.00%)  1/57 (1.75%) 
Phimosis  1  0/56 (0.00%)  0/56 (0.00%)  0/57 (0.00%)  1/56 (1.79%)  0/57 (0.00%)  0/57 (0.00%) 
Pulmonary artery stenosis congenital  1  0/56 (0.00%)  0/56 (0.00%)  0/57 (0.00%)  1/56 (1.79%)  0/57 (0.00%)  0/57 (0.00%) 
Trisomy 21  1  0/56 (0.00%)  0/56 (0.00%)  0/57 (0.00%)  1/56 (1.79%)  0/57 (0.00%)  0/57 (0.00%) 
Ventricular septal defect  1  0/56 (0.00%)  0/56 (0.00%)  0/57 (0.00%)  1/56 (1.79%)  1/57 (1.75%)  0/57 (0.00%) 
Eye disorders             
Conjunctival hyperaemia  1  0/56 (0.00%)  0/56 (0.00%)  0/57 (0.00%)  0/56 (0.00%)  0/57 (0.00%)  1/57 (1.75%) 
Gastrointestinal disorders             
Abdominal pain  1  0/56 (0.00%)  0/56 (0.00%)  0/57 (0.00%)  0/56 (0.00%)  1/57 (1.75%)  0/57 (0.00%) 
Constipation  1  0/56 (0.00%)  0/56 (0.00%)  0/57 (0.00%)  0/56 (0.00%)  1/57 (1.75%)  0/57 (0.00%) 
Diarrhoea  1  0/56 (0.00%)  0/56 (0.00%)  0/57 (0.00%)  1/56 (1.79%)  0/57 (0.00%)  1/57 (1.75%) 
Duodenal stenosis  1  0/56 (0.00%)  0/56 (0.00%)  0/57 (0.00%)  1/56 (1.79%)  0/57 (0.00%)  0/57 (0.00%) 
General disorders             
Pyrexia  1  0/56 (0.00%)  1/56 (1.79%)  0/57 (0.00%)  0/56 (0.00%)  0/57 (0.00%)  1/57 (1.75%) 
Hepatobiliary disorders             
Hyperbilirubinaemia  1  0/56 (0.00%)  0/56 (0.00%)  0/57 (0.00%)  1/56 (1.79%)  1/57 (1.75%)  1/57 (1.75%) 
Immune system disorders             
Allergy to arthropod bite  1  0/56 (0.00%)  0/56 (0.00%)  0/57 (0.00%)  1/56 (1.79%)  0/57 (0.00%)  0/57 (0.00%) 
Infections and infestations             
Nasopharyngitis  1  0/56 (0.00%)  0/56 (0.00%)  0/57 (0.00%)  0/56 (0.00%)  1/57 (1.75%)  0/57 (0.00%) 
Oral candidiasis  1  0/56 (0.00%)  0/56 (0.00%)  0/57 (0.00%)  0/56 (0.00%)  1/57 (1.75%)  0/57 (0.00%) 
Pneumonia  1  0/56 (0.00%)  0/56 (0.00%)  0/57 (0.00%)  1/56 (1.79%)  0/57 (0.00%)  0/57 (0.00%) 
Rhinitis  1  0/56 (0.00%)  0/56 (0.00%)  0/57 (0.00%)  1/56 (1.79%)  1/57 (1.75%)  0/57 (0.00%) 
Upper respiratory tract infection  1  0/56 (0.00%)  0/56 (0.00%)  0/57 (0.00%)  0/56 (0.00%)  1/57 (1.75%)  0/57 (0.00%) 
Investigations             
Alanine aminotransferase increased  1  0/56 (0.00%)  0/56 (0.00%)  0/57 (0.00%)  2/56 (3.57%)  2/57 (3.51%)  2/57 (3.51%) 
Aspartate aminotransferase increased  1  0/56 (0.00%)  0/56 (0.00%)  0/57 (0.00%)  10/56 (17.86%)  11/57 (19.30%)  10/57 (17.54%) 
Blood bicarbonate decreased  1  0/56 (0.00%)  0/56 (0.00%)  0/57 (0.00%)  3/56 (5.36%)  6/57 (10.53%)  2/57 (3.51%) 
Blood calcium increased  1  0/56 (0.00%)  0/56 (0.00%)  0/57 (0.00%)  5/56 (8.93%)  1/57 (1.75%)  4/57 (7.02%) 
Blood creatine increased  1  0/56 (0.00%)  0/56 (0.00%)  0/57 (0.00%)  0/56 (0.00%)  0/57 (0.00%)  1/57 (1.75%) 
Blood creatinine increased  1  0/56 (0.00%)  0/56 (0.00%)  0/57 (0.00%)  2/56 (3.57%)  2/57 (3.51%)  6/57 (10.53%) 
Blood glucose decreased  1  0/56 (0.00%)  0/56 (0.00%)  0/57 (0.00%)  1/56 (1.79%)  0/57 (0.00%)  0/57 (0.00%) 
Blood potassium increased  1  0/56 (0.00%)  0/56 (0.00%)  0/57 (0.00%)  4/56 (7.14%)  2/57 (3.51%)  2/57 (3.51%) 
Blood sodium decreased  1  0/56 (0.00%)  0/56 (0.00%)  0/57 (0.00%)  0/56 (0.00%)  1/57 (1.75%)  2/57 (3.51%) 
Blood sodium increased  1  0/56 (0.00%)  0/56 (0.00%)  0/57 (0.00%)  2/56 (3.57%)  0/57 (0.00%)  0/57 (0.00%) 
Blood thyroid stimulating hormone increased  1  0/56 (0.00%)  0/56 (0.00%)  0/57 (0.00%)  0/56 (0.00%)  1/57 (1.75%)  0/57 (0.00%) 
Haemoglobin decreased  1  0/56 (0.00%)  0/56 (0.00%)  0/57 (0.00%)  3/56 (5.36%)  0/57 (0.00%)  2/57 (3.51%) 
Heart rate increased  1  0/56 (0.00%)  0/56 (0.00%)  0/57 (0.00%)  0/56 (0.00%)  1/57 (1.75%)  0/57 (0.00%) 
Liver function test abnormal  1  0/56 (0.00%)  0/56 (0.00%)  0/57 (0.00%)  1/56 (1.79%)  0/57 (0.00%)  0/57 (0.00%) 
Neutrophil count decreased  1  0/56 (0.00%)  0/56 (0.00%)  0/57 (0.00%)  0/56 (0.00%)  0/57 (0.00%)  2/57 (3.51%) 
Platelet count decreased  1  0/56 (0.00%)  0/56 (0.00%)  0/57 (0.00%)  0/56 (0.00%)  0/57 (0.00%)  1/57 (1.75%) 
White blood cell count increased  1  0/56 (0.00%)  0/56 (0.00%)  0/57 (0.00%)  0/56 (0.00%)  1/57 (1.75%)  0/57 (0.00%) 
Metabolism and nutrition disorders             
Hypocalcaemia  1  0/56 (0.00%)  0/56 (0.00%)  0/57 (0.00%)  0/56 (0.00%)  0/57 (0.00%)  1/57 (1.75%) 
Hypoglycaemia  1  0/56 (0.00%)  0/56 (0.00%)  0/57 (0.00%)  0/56 (0.00%)  4/57 (7.02%)  2/57 (3.51%) 
Hypoglycaemia neonatal  1  0/56 (0.00%)  0/56 (0.00%)  0/57 (0.00%)  2/56 (3.57%)  1/57 (1.75%)  1/57 (1.75%) 
Neonatal hyponatraemia  1  0/56 (0.00%)  0/56 (0.00%)  0/57 (0.00%)  0/56 (0.00%)  0/57 (0.00%)  1/57 (1.75%) 
Pregnancy, puerperium and perinatal conditions             
Cephalhaematoma  1  0/56 (0.00%)  0/56 (0.00%)  0/57 (0.00%)  0/56 (0.00%)  0/57 (0.00%)  2/57 (3.51%) 
Jaundice neonatal  1  0/56 (0.00%)  0/56 (0.00%)  0/57 (0.00%)  1/56 (1.79%)  1/57 (1.75%)  2/57 (3.51%) 
Premature baby  1  0/56 (0.00%)  0/56 (0.00%)  0/57 (0.00%)  0/56 (0.00%)  1/57 (1.75%)  0/57 (0.00%) 
Small for dates baby  1  0/56 (0.00%)  0/56 (0.00%)  0/57 (0.00%)  1/56 (1.79%)  0/57 (0.00%)  0/57 (0.00%) 
Umbilical granuloma  1  0/56 (0.00%)  0/56 (0.00%)  0/57 (0.00%)  0/56 (0.00%)  2/57 (3.51%)  1/57 (1.75%) 
Renal and urinary disorders             
Haematuria  1  0/56 (0.00%)  0/56 (0.00%)  0/57 (0.00%)  0/56 (0.00%)  0/57 (0.00%)  1/57 (1.75%) 
Proteinuria  1  0/56 (0.00%)  0/56 (0.00%)  0/57 (0.00%)  3/56 (5.36%)  1/57 (1.75%)  0/57 (0.00%) 
Respiratory, thoracic and mediastinal disorders             
Acute respiratory distress syndrome  1  0/56 (0.00%)  0/56 (0.00%)  0/57 (0.00%)  0/56 (0.00%)  1/57 (1.75%)  0/57 (0.00%) 
Neonatal asphyxia  1  0/56 (0.00%)  0/56 (0.00%)  0/57 (0.00%)  1/56 (1.79%)  0/57 (0.00%)  1/57 (1.75%) 
Neonatal respiratory distress syndrome  1  0/56 (0.00%)  0/56 (0.00%)  0/57 (0.00%)  0/56 (0.00%)  0/57 (0.00%)  1/57 (1.75%) 
Neonatal tachypnoea  1  0/56 (0.00%)  0/56 (0.00%)  0/57 (0.00%)  1/56 (1.79%)  0/57 (0.00%)  0/57 (0.00%) 
Pneumonia aspiration  1  0/56 (0.00%)  0/56 (0.00%)  0/57 (0.00%)  1/56 (1.79%)  0/57 (0.00%)  0/57 (0.00%) 
Rhinorrhoea  1  0/56 (0.00%)  0/56 (0.00%)  0/57 (0.00%)  0/56 (0.00%)  1/57 (1.75%)  0/57 (0.00%) 
Tachypnoea  1  0/56 (0.00%)  0/56 (0.00%)  0/57 (0.00%)  0/56 (0.00%)  0/57 (0.00%)  1/57 (1.75%) 
Skin and subcutaneous tissue disorders             
Eczema  1  0/56 (0.00%)  0/56 (0.00%)  0/57 (0.00%)  0/56 (0.00%)  1/57 (1.75%)  0/57 (0.00%) 
Heat rash  1  0/56 (0.00%)  0/56 (0.00%)  0/57 (0.00%)  0/56 (0.00%)  0/57 (0.00%)  1/57 (1.75%) 
Rash  1  0/56 (0.00%)  0/56 (0.00%)  0/57 (0.00%)  2/56 (3.57%)  0/57 (0.00%)  0/57 (0.00%) 
Rash erythematous  1  0/56 (0.00%)  0/56 (0.00%)  0/57 (0.00%)  0/56 (0.00%)  1/57 (1.75%)  0/57 (0.00%) 
Rash maculo-papular  1  0/56 (0.00%)  0/56 (0.00%)  0/57 (0.00%)  1/56 (1.79%)  0/57 (0.00%)  0/57 (0.00%) 
Urticaria  1  0/56 (0.00%)  0/56 (0.00%)  0/57 (0.00%)  0/56 (0.00%)  1/57 (1.75%)  0/57 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 14.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Mother: LPV/r x 7d Mother: no LPV/r Mother: LPV/r x 30d Infant: LPV/r x 7d Infant: no LPV/r Infant: LPV/r x 30d
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   33/56 (58.93%)   43/56 (76.79%)   45/57 (78.95%)   48/56 (85.71%)   51/57 (89.47%)   49/57 (85.96%) 
Blood and lymphatic system disorders             
Anaemia  1  1/56 (1.79%)  0/56 (0.00%)  0/57 (0.00%)  11/56 (19.64%)  15/57 (26.32%)  12/57 (21.05%) 
Anaemia neonatal  1  0/56 (0.00%)  0/56 (0.00%)  0/57 (0.00%)  4/56 (7.14%)  0/57 (0.00%)  3/57 (5.26%) 
Ear and labyrinth disorders             
Ear pain  1  3/56 (5.36%)  2/56 (3.57%)  0/57 (0.00%)  0/56 (0.00%)  0/57 (0.00%)  0/57 (0.00%) 
Eye disorders             
Conjunctival discolouration  1  0/56 (0.00%)  0/56 (0.00%)  0/57 (0.00%)  5/56 (8.93%)  1/57 (1.75%)  4/57 (7.02%) 
Conjunctivitis  1  0/56 (0.00%)  0/56 (0.00%)  0/57 (0.00%)  2/56 (3.57%)  0/57 (0.00%)  3/57 (5.26%) 
Eye discharge  1  1/56 (1.79%)  0/56 (0.00%)  0/57 (0.00%)  2/56 (3.57%)  3/57 (5.26%)  6/57 (10.53%) 
Gastrointestinal disorders             
Abdominal distension  1  0/56 (0.00%)  0/56 (0.00%)  0/57 (0.00%)  0/56 (0.00%)  0/57 (0.00%)  3/57 (5.26%) 
Diarrhoea  1  2/56 (3.57%)  3/56 (5.36%)  2/57 (3.51%)  5/56 (8.93%)  3/57 (5.26%)  4/57 (7.02%) 
Diarrhoea neonatal  1  0/56 (0.00%)  0/56 (0.00%)  0/57 (0.00%)  0/56 (0.00%)  3/57 (5.26%)  0/57 (0.00%) 
Vomiting  1  1/56 (1.79%)  4/56 (7.14%)  2/57 (3.51%)  0/56 (0.00%)  1/57 (1.75%)  1/57 (1.75%) 
General disorders             
Pyrexia  1  6/56 (10.71%)  9/56 (16.07%)  8/57 (14.04%)  9/56 (16.07%)  10/57 (17.54%)  16/57 (28.07%) 
Secretion discharge  1  0/56 (0.00%)  0/56 (0.00%)  0/57 (0.00%)  0/56 (0.00%)  4/57 (7.02%)  3/57 (5.26%) 
Hepatobiliary disorders             
Jaundice  1  0/56 (0.00%)  0/56 (0.00%)  0/57 (0.00%)  8/56 (14.29%)  6/57 (10.53%)  11/57 (19.30%) 
Immune system disorders             
ABO incompatibility  1  0/56 (0.00%)  0/56 (0.00%)  0/57 (0.00%)  0/56 (0.00%)  1/57 (1.75%)  3/57 (5.26%) 
Infections and infestations             
Bronchitis  1  0/56 (0.00%)  3/56 (5.36%)  1/57 (1.75%)  0/56 (0.00%)  0/57 (0.00%)  0/57 (0.00%) 
Nasopharyngitis  1  2/56 (3.57%)  5/56 (8.93%)  6/57 (10.53%)  2/56 (3.57%)  5/57 (8.77%)  7/57 (12.28%) 
Pharyngitis  1  1/56 (1.79%)  4/56 (7.14%)  2/57 (3.51%)  0/56 (0.00%)  0/57 (0.00%)  0/57 (0.00%) 
Postoperative wound infection  1  1/56 (1.79%)  6/56 (10.71%)  3/57 (5.26%)  0/56 (0.00%)  0/57 (0.00%)  0/57 (0.00%) 
Tonsillitis  1  0/56 (0.00%)  3/56 (5.36%)  0/57 (0.00%)  0/56 (0.00%)  0/57 (0.00%)  0/57 (0.00%) 
Upper respiratory tract infection  1  3/56 (5.36%)  4/56 (7.14%)  2/57 (3.51%)  4/56 (7.14%)  1/57 (1.75%)  2/57 (3.51%) 
Vulvovaginal candidiasis  1  2/56 (3.57%)  2/56 (3.57%)  4/57 (7.02%)  0/56 (0.00%)  0/57 (0.00%)  0/57 (0.00%) 
Investigations             
Alanine aminotransferase increased  1  2/56 (3.57%)  5/56 (8.93%)  1/57 (1.75%)  1/56 (1.79%)  2/57 (3.51%)  5/57 (8.77%) 
Aspartate aminotransferase increased  1  4/56 (7.14%)  7/56 (12.50%)  5/57 (8.77%)  6/56 (10.71%)  4/57 (7.02%)  3/57 (5.26%) 
Blood bicarbonate abnormal  1  0/56 (0.00%)  0/56 (0.00%)  0/57 (0.00%)  6/56 (10.71%)  7/57 (12.28%)  3/57 (5.26%) 
Blood bilirubin increased  1  2/56 (3.57%)  1/56 (1.79%)  3/57 (5.26%)  1/56 (1.79%)  2/57 (3.51%)  0/57 (0.00%) 
Blood creatinine increased  1  0/56 (0.00%)  0/56 (0.00%)  0/57 (0.00%)  2/56 (3.57%)  0/57 (0.00%)  5/57 (8.77%) 
Blood glucose abnormal  1  3/56 (5.36%)  4/56 (7.14%)  2/57 (3.51%)  2/56 (3.57%)  6/57 (10.53%)  3/57 (5.26%) 
Blood glucose decreased  1  6/56 (10.71%)  3/56 (5.36%)  3/57 (5.26%)  0/56 (0.00%)  2/57 (3.51%)  2/57 (3.51%) 
Blood glucose increased  1  8/56 (14.29%)  3/56 (5.36%)  7/57 (12.28%)  0/56 (0.00%)  0/57 (0.00%)  0/57 (0.00%) 
Blood potassium increased  1  0/56 (0.00%)  0/56 (0.00%)  0/57 (0.00%)  5/56 (8.93%)  4/57 (7.02%)  6/57 (10.53%) 
Blood sodium decreased  1  0/56 (0.00%)  0/56 (0.00%)  0/57 (0.00%)  7/56 (12.50%)  7/57 (12.28%)  6/57 (10.53%) 
Cardiac murmur  1  0/56 (0.00%)  0/56 (0.00%)  0/57 (0.00%)  4/56 (7.14%)  1/57 (1.75%)  3/57 (5.26%) 
Haemoglobin abnormal  1  1/56 (1.79%)  0/56 (0.00%)  2/57 (3.51%)  23/56 (41.07%)  15/57 (26.32%)  20/57 (35.09%) 
Haemoglobin decreased  1  15/56 (26.79%)  16/56 (28.57%)  21/57 (36.84%)  22/56 (39.29%)  18/57 (31.58%)  22/57 (38.60%) 
Neutrophil count decreased  1  1/56 (1.79%)  2/56 (3.57%)  4/57 (7.02%)  5/56 (8.93%)  8/57 (14.04%)  3/57 (5.26%) 
Platelet count decreased  1  4/56 (7.14%)  2/56 (3.57%)  2/57 (3.51%)  3/56 (5.36%)  0/57 (0.00%)  2/57 (3.51%) 
Metabolism and nutrition disorders             
Hypoglycaemia neonatal  1  0/56 (0.00%)  0/56 (0.00%)  0/57 (0.00%)  0/56 (0.00%)  4/57 (7.02%)  3/57 (5.26%) 
Hyponatraemia  1  0/56 (0.00%)  0/56 (0.00%)  0/57 (0.00%)  3/56 (5.36%)  2/57 (3.51%)  0/57 (0.00%) 
Pregnancy, puerperium and perinatal conditions             
Hypothermia neonatal  1  0/56 (0.00%)  0/56 (0.00%)  0/57 (0.00%)  3/56 (5.36%)  0/57 (0.00%)  3/57 (5.26%) 
Jaundice neonatal  1  0/56 (0.00%)  0/56 (0.00%)  0/57 (0.00%)  14/56 (25.00%)  12/57 (21.05%)  15/57 (26.32%) 
Small for dates baby  1  0/56 (0.00%)  0/56 (0.00%)  0/57 (0.00%)  3/56 (5.36%)  1/57 (1.75%)  0/57 (0.00%) 
Umbilical granuloma  1  0/56 (0.00%)  0/56 (0.00%)  0/57 (0.00%)  1/56 (1.79%)  3/57 (5.26%)  3/57 (5.26%) 
Reproductive system and breast disorders             
Cervical dysplasia  1  0/56 (0.00%)  2/56 (3.57%)  6/57 (10.53%)  0/56 (0.00%)  0/57 (0.00%)  0/57 (0.00%) 
Vaginal discharge  1  3/56 (5.36%)  3/56 (5.36%)  0/57 (0.00%)  0/56 (0.00%)  0/57 (0.00%)  0/57 (0.00%) 
Vaginal haemorrhage  1  0/56 (0.00%)  0/56 (0.00%)  3/57 (5.26%)  0/56 (0.00%)  0/57 (0.00%)  0/57 (0.00%) 
Respiratory, thoracic and mediastinal disorders             
Cough  1  3/56 (5.36%)  7/56 (12.50%)  3/57 (5.26%)  7/56 (12.50%)  5/57 (8.77%)  11/57 (19.30%) 
Dyspnoea  1  0/56 (0.00%)  1/56 (1.79%)  0/57 (0.00%)  3/56 (5.36%)  1/57 (1.75%)  1/57 (1.75%) 
Neonatal tachypnoea  1  0/56 (0.00%)  0/56 (0.00%)  0/57 (0.00%)  0/56 (0.00%)  1/57 (1.75%)  3/57 (5.26%) 
Oropharyngeal pain  1  2/56 (3.57%)  7/56 (12.50%)  2/57 (3.51%)  0/56 (0.00%)  0/57 (0.00%)  0/57 (0.00%) 
Rhinorrhoea  1  4/56 (7.14%)  6/56 (10.71%)  3/57 (5.26%)  8/56 (14.29%)  5/57 (8.77%)  11/57 (19.30%) 
Skin and subcutaneous tissue disorders             
Dermatitis allergic  1  1/56 (1.79%)  4/56 (7.14%)  4/57 (7.02%)  3/56 (5.36%)  2/57 (3.51%)  2/57 (3.51%) 
Dermatitis contact  1  0/56 (0.00%)  1/56 (1.79%)  1/57 (1.75%)  4/56 (7.14%)  1/57 (1.75%)  0/57 (0.00%) 
Papule  1  0/56 (0.00%)  1/56 (1.79%)  0/57 (0.00%)  2/56 (3.57%)  3/57 (5.26%)  1/57 (1.75%) 
Rash  1  0/56 (0.00%)  0/56 (0.00%)  1/57 (1.75%)  3/56 (5.36%)  5/57 (8.77%)  3/57 (5.26%) 
Rash erythematous  1  0/56 (0.00%)  0/56 (0.00%)  0/57 (0.00%)  5/56 (8.93%)  1/57 (1.75%)  1/57 (1.75%) 
Vascular disorders             
Pallor  1  0/56 (0.00%)  0/56 (0.00%)  0/57 (0.00%)  4/56 (7.14%)  3/57 (5.26%)  5/57 (8.77%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 14.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
In accordance with the Clinical Trials Agreement between NIAID (DAIDS) and company collaborators, NIAID (DAIDS) provides companies with a copy of any abstract, press release, or manuscript prior to submission for publication with sufficient time for company review and comment. The publication/other disclosure can be delayed for up to 30 additional business days for manuscripts and five (5) business days for abstracts, to preserve U.S. or foreign patent or other intellectual property rights”.
Results Point of Contact
Name/Title: Clinicaltrials.gov Coordinator
Organization: Center for Biostatistics in AIDS Research, Harvard School of Public Health
Phone: (617) 432-2829
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00109590     History of Changes
Other Study ID Numbers: P1032
10137 ( Registry Identifier: DAIDS ES )
PACTG P1032
First Submitted: April 29, 2005
First Posted: May 2, 2005
Results First Submitted: June 26, 2012
Results First Posted: November 6, 2012
Last Update Posted: January 13, 2015