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Antiviral Responses to NNRTI-Based vs. PI-Based ARV Therapy in HIV Infected Infants Who Have or Have Not Received Single Dose NVP for Prevention of Mother-to-Child Transmission of HIV (P1060)

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ClinicalTrials.gov Identifier: NCT00307151
Recruitment Status : Completed
First Posted : March 27, 2006
Results First Posted : August 3, 2011
Last Update Posted : April 13, 2017
Sponsor:
Collaborators:
National Institute of Allergy and Infectious Diseases (NIAID)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
International Maternal Pediatric Adolescent AIDS Clinical Trials Group

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition HIV Infections
Interventions Drug: Lamivudine
Drug: Lopinavir/ritonavir
Drug: Nevirapine
Drug: Zidovudine
Enrollment 452
Recruitment Details Study participants were recruited at 10 study sites, 4 in South Africa and 1 each in Uganda, Zimbabwe, Zambia, Malawi, Tanzania and India between November 9, 2006 and March 19, 2010.
Pre-assignment Details Infants and children 6 - 36 months of age (lower age limit changed to 2 months in Protocol Version 4.0) were stratified by age (2-<6 months, 6-<12 months and >=12 months) and randomly assigned to receive either AZT/3TC/NVP or AZT/3TC/LPV/r. One subject was randomized but never started study treatment.
Arm/Group Title Coh I: NVP Coh I: LPV/r Coh II: NVP Coh II: LPV/r
Hide Arm/Group Description Cohort I: Previously received single dose nevirapine (SD NVP). Randomly assigned to receive an NNRTI-based regimen. Cohort I: Previously received SD NVP. Randomly assigned to receive a PI-based regimen. Cohort II: Did not previously receive SD NVP. Randomly assigned to receive an NNRTI-based regimen Cohort II: Did not previously receive SD NVP. Randomly assigned to receive a PI-based regimen
Period Title: Overall Study
Started 82 82 147 140 [1]
Completed 71 [2] 75 [2] 127 [3] 129 [3]
Not Completed 11 7 20 11
Reason Not Completed
Death             4             3             10             3
Severe debilitation, unable to continue             1             0             0             0
Subject unable to get to clinic             1             0             6             2
Withdrew consent             0             1             1             3
Not willing to adhere to study reqs             2             0             2             2
Clinic unable to contact subject             3             3             1             1
[1]
One participant never started treatment, were not followed and not included in analysis.
[2]
Results are through date DSMB closed Cohort I to accrual (April 20, 2009)
[3]
Results are through date DSMB recommended Cohort II results be unblinded (October 27, 2010)
Arm/Group Title Coh I: NVP Coh I: LPV/r Coh II: NVP Coh II: LPV/r Total
Hide Arm/Group Description Cohort I: Previously received single dose nevirapine (SD NVP). Randomly assigned to receive an NNRTI-based regimen. Cohort I: Previously received SD NVP. Randomly assigned to receive a PI-based regimen. Cohort II: Did not previously receive SD NVP. Randomly assigned to receive an NNRTI-based regimen Cohort II: Did not previously receive SD NVP. Randomly assigned to receive a PI-based regimen Total of all reporting groups
Overall Number of Baseline Participants 82 82 147 140 451
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 82 participants 82 participants 147 participants 140 participants 451 participants
<12 months 60 63 41 36 200
>=12 months 22 19 106 104 251
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 82 participants 82 participants 147 participants 140 participants 451 participants
Female
46
  56.1%
41
  50.0%
78
  53.1%
72
  51.4%
237
  52.5%
Male
36
  43.9%
41
  50.0%
69
  46.9%
68
  48.6%
214
  47.5%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 82 participants 82 participants 147 participants 140 participants 451 participants
Black African 81 81 132 134 428
Coloured 1 1 1 2 5
Native of India 0 0 12 4 16
Not available 0 0 2 0 2
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 82 participants 82 participants 147 participants 140 participants 451 participants
Tanzania 2 0 8 7 17
Zambia 2 4 14 18 38
Uganda 1 4 20 20 45
Malawi 2 0 16 20 38
South Africa 71 65 41 36 213
Zimbabwe 4 9 36 35 84
India 0 0 12 4 16
Ever breastfed  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 82 participants 82 participants 147 participants 140 participants 451 participants
Yes 15 19 118 115 267
No 67 63 29 25 184
Documentation of SD NVP use at birth  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 82 participants 82 participants 147 participants 140 participants 451 participants
Born before NVP available/mother known to have HIV 0 0 116 104 220
Medical record review 62 63 10 12 147
Verbal evidence only 20 19 19 22 80
Found to have received SD NVP 0 0 2 2 4
WHO Stage   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 82 participants 82 participants 147 participants 140 participants 451 participants
I 7 18 29 25 79
II 23 22 26 27 98
III 39 38 80 77 234
IV 13 4 12 11 40
[1]
Measure Description: World Health Organization (WHO) staging system for HIV infection and disease.
HIV-1 RNA  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 82 participants 82 participants 147 participants 140 participants 451 participants
<100,000 copies/ml 6 5 20 27 58
100,000 - < 750,000 copies/ml 27 34 70 53 184
>=750,000 copies/ml 49 43 57 60 209
CD4 Percent  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 82 participants 82 participants 147 participants 140 participants 451 participants
<15 Percent 24 21 73 69 187
15 Percent - < 25 Percent 37 37 60 54 188
>= 25 Percent 21 24 13 17 75
Missing 0 0 1 0 1
NVP resistance  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 82 participants 82 participants 147 participants 140 participants 451 participants
Yes 7 11 1 4 23
No 68 62 110 91 331
Not available 7 9 36 45 97
1.Primary Outcome
Title Percent of Participants With Treatment Failure, Defined as a Confirmed Virologic Failure or Permanent Discontinuation of the Randomized NNRTI or PI Component of Study Treatment
Hide Description Treatment failure is defined as a confirmed plasma HIV-1 RNA level that is <1 log10 copies/mL below the study entry value at 12 to 24 weeks after treatment is initiated OR a confirmed plasma HIV-1 RNA level >400 copies/mL at 24 weeks OR permanent discontinuation of the randomized NNRTI or PI component of study treatment at or prior to 24 weeks of treatment for any reason including death. Results report percent of participants reaching a treatment failure endpoint by week 24 calculated using the Kaplan-Meier method.
Time Frame Earlier of 24 weeks or date of DSMB decision to unblind Cohort results (Coh I: April 20, 2009; Coh II: October 27, 2010)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis uses intent to treat population
Arm/Group Title Coh I: NVP Coh I: LPV/r Coh II: NVP Coh II: LPV/r
Hide Arm/Group Description:
Cohort I: Previously received single dose nevirapine (SD NVP). Randomly assigned to receive an NNRTI-based regimen.
Cohort I: Previously received SD NVP. Randomly assigned to receive a PI-based regimen.
Cohort II: Did not previously receive SD NVP. Randomly assigned to receive an NNRTI-based regimen
Cohort II: Did not previously receive SD NVP. Randomly assigned to receive a PI-based regimen
Overall Number of Participants Analyzed 82 82 147 140
Measure Type: Number
Unit of Measure: Percent of participants
39.6 21.7 40.8 19.3
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Coh I: NVP, Coh I: LPV/r
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.015
Comments P-value not adjusted for multiple interim analyses, but adjustment would be negligible because Peto-Haybittle spending function used as basis for calculating repeated confidence intervals used in interim monitoring.
Method t-test, 2 sided
Comments Risk difference estimate stratified by age (<12 months vs. >=12 months)and reports rate on NVP arm minus rate on LPV/r arm
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 18.6
Confidence Interval (2-Sided) 95%
3.7 to 33.6
Estimation Comments Endpoint rates with standard errors calculated from Kaplan-Meier curves for each treatment group and age stratum. Differences in week 24 failure proportions by treatment calculated weighted by the inverse of the variance in each age stratum.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Coh II: NVP, Coh II: LPV/r
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value not adjusted for multiple interim analyses, but adjustment would be negligible because Peto-Haybittle spending function used as basis for calculating repeated confidence intervals used in interim monitoring.
Method t-test, 2 sided
Comments Risk difference estimate stratified by age (<12 months vs. >=12 months) and reports rate on NVP arm minus rate on LPV/r arm
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 21.5
Confidence Interval (2-Sided) 95%
11.2 to 31.8
Estimation Comments Endpoint rates with standard errors calculated from Kaplan-Meier curves for each treatment group and age stratum. Differences in week 24 failure proportions by treatment calculated weighted by the inverse of the variance in each age stratum.
2.Secondary Outcome
Title Time From Randomization to Treatment Failure, Defined as Virologic Failure or Permanent Discontinuation of the Randomized NNRTI or PI Component of Study Treatment
Hide Description Treatment failure is defined as a confirmed plasma HIV-1 RNA level that is <1 log10 copies/mL below the study entry value at 12 to 24 weeks after treatment is initiated OR a confirmed plasma HIV-1 RNA level >400 copies/mL at 24 weeks OR a confirmed viral rebound >4000 copies/mL after week 24 OR permanent discontinuation of the randomized NNRTI or PI component of study treatment for any reason including death.
Time Frame Until date of DSMB decision to unblind Cohort results (Coh I: April 20, 2009 - median follow-up 48 weeks and range 0 - 125 weeks; Coh II: October 27, 2010 - median follow-up 72 weeks and range from 0 to 204 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis uses intent to treat population
Arm/Group Title Coh I: NVP Coh I: LPV/r Coh II: NVP Coh II: LPV/r
Hide Arm/Group Description:
Cohort I: Previously received single dose nevirapine (SD NVP). Randomly assigned to receive an NNRTI-based regimen.
Cohort I: Previously received SD NVP. Randomly assigned to receive a PI-based regimen.
Cohort II: Did not previously receive SD NVP. Randomly assigned to receive an NNRTI-based regimen
Cohort II: Did not previously receive SD NVP. Randomly assigned to receive a PI-based regimen
Overall Number of Participants Analyzed 82 82 147 140
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Weeks
10th percentile
12
(4 to 12)
4
(4 to 16)
4
(2 to 8)
14
(8 to 24)
25th percentile
16
(12 to 24)
36 [1] 
(16 to NA)
16
(12 to 24)
36
(24 to 108)
[1]
Not estimable as upper limit for survival function at all weeks is above 75%
3.Secondary Outcome
Title Percent of Participants Experiencing Virologic Failure
Hide Description Virologic failure is defined as a confirmed plasma HIV-1 RNA level that is <1 log10 copies/mL below the study entry value at 12 to 24 weeks after treatment is initiated OR a confirmed plasma HIV-1 RNA level >400 copies/mL at 24 weeks OR death on or before 24 weeks. Results report percent of participants reaching a virologic failure endpoint by week 24 calculated using the Kaplan-Meier method.
Time Frame Earlier of 24 weeks or date of DSMB decision to unblind Cohort results (Coh I: April 20, 2009; Coh II: October 27, 2010)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis uses intent to treat population.
Arm/Group Title Coh I: NVP Coh I: LPV/r Coh II: NVP Coh II: LPV/r
Hide Arm/Group Description:
Cohort I: Previously received single dose nevirapine (SD NVP). Randomly assigned to receive an NNRTI-based regimen.
Cohort I: Previously received SD NVP. Randomly assigned to receive a PI-based regimen.
Cohort II: Did not previously receive SD NVP. Randomly assigned to receive an NNRTI-based regimen
Cohort II: Did not previously receive SD NVP. Randomly assigned to receive a PI-based regimen
Overall Number of Participants Analyzed 82 82 147 140
Measure Type: Number
Unit of Measure: Percent of participants
27.4 10.4 28.6 12.9
4.Secondary Outcome
Title Time From Randomization to Virologic Failure
Hide Description Virologic failure is defined as the earlier of a confirmed plasma HIV-1 RNA level that is <1 log10 copies/mL below the study entry value at 12 to 24 weeks after treatment is initiated OR a confirmed plasma HIV-1 RNA level >400 copies/mL at 24 weeks OR a confirmed viral rebound >4000 copies/mL after week 24 OR death.
Time Frame Until date of DSMB decision to unblind Cohort results (Coh I: April 20, 2009 - median follow-up 48 weeks and range 0 - 125 weeks; Coh II: October 27, 2010 - median follow-up 72 weeks and range from 0 to 204 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis uses intent to treat population
Arm/Group Title Coh I: NVP Coh I: LPV/r Coh II: NVP Coh II: LPV/r
Hide Arm/Group Description:
Cohort I: Previously received single dose nevirapine (SD NVP). Randomly assigned to receive an NNRTI-based regimen.
Cohort I: Previously received SD NVP. Randomly assigned to receive a PI-based regimen.
Cohort II: Did not previously receive SD NVP. Randomly assigned to receive an NNRTI-based regimen
Cohort II: Did not previously receive SD NVP. Randomly assigned to receive a PI-based regimen
Overall Number of Participants Analyzed 82 82 147 140
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Weeks
5th percentile
12
(4 to 12)
16
(2 to 24)
12
(2 to 16)
16
(12 to 24)
10th percentile
12
(12 to 24)
24 [1] 
(12 to NA)
16
(12 to 24)
24
(16 to 36)
[1]
Not estimable as upper limit for survival function at all weeks above 90%
5.Secondary Outcome
Title Time From Start of Study Treatment to First New Grade >=3 Lab Abnormality, Sign or Symptom Occurring on Study Treatment
Hide Description Safety events include lab abnormalities, signs or symptoms of grade 3 or higher. Events were graded according to the Division of AIDS Table for Grading Severity of Adult and Pediatric Adverse Events, Version 1.0. Events defined as new if first occurrence was after initiation of study treatment or if severity increased from entry and while on the NNRTI or PI component of study treatment.
Time Frame On randomized NNRTI or PI component of study treatment and until date of DSMB decision to unblind Cohort results (Coh I: April 20, 2009; Coh II: October 27, 2010)
Hide Outcome Measure Data
Hide Analysis Population Description
Uses follow-up from start of NVP or LPV/r component of study treatment until component switched or date of DSMB decision to unblind results, whichever occurred first
Arm/Group Title Coh I: NVP Coh I: LPV/r Coh II: NVP Coh II: LPV/r
Hide Arm/Group Description:
Cohort I: Previously received single dose nevirapine (SD NVP). Randomly assigned to receive an NNRTI-based regimen.
Cohort I: Previously received SD NVP. Randomly assigned to receive a PI-based regimen.
Cohort II: Did not previously receive SD NVP. Randomly assigned to receive an NNRTI-based regimen
Cohort II: Did not previously receive SD NVP. Randomly assigned to receive a PI-based regimen
Overall Number of Participants Analyzed 82 82 147 140
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Weeks
10th percentile
4
(2 to 12)
8
(2 to 25)
3
(1 to 4)
4
(2 to 5)
25th percentile
24 [1] 
(12 to NA)
36
(14 to 86)
4
(4 to 6)
12
(7 to 24)
[1]
Not estimable as upper limit for survival function at all weeks above 75%
6.Secondary Outcome
Title Number of Participants Developing New NRTI, NNRTI or PI-resistant Virus
Hide Description Numbers of participants developing new NRTI, NNRTI or PI-resistant virus after reaching a virologic failure endpoint
Time Frame Until date of DSMB decision to unblind Cohort results (Coh I: April 20, 2009 - median follow-up 48 weeks and range 0 - 125 weeks; Coh II: October 27, 2010 - median follow-up 72 weeks and range from 0 to 204 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Results included for any participant who was a virologic failure as defined in secondary outcome 4 and who had results available at study entry and virologic failure.
Arm/Group Title Coh I: NVP Coh I: LPV/r Coh II: NVP Coh II: LPV/r
Hide Arm/Group Description:
Cohort I: Previously received single dose nevirapine (SD NVP). Randomly assigned to receive an NNRTI-based regimen.
Cohort I: Previously received SD NVP. Randomly assigned to receive a PI-based regimen.
Cohort II: Did not previously receive SD NVP. Randomly assigned to receive an NNRTI-based regimen
Cohort II: Did not previously receive SD NVP. Randomly assigned to receive a PI-based regimen
Overall Number of Participants Analyzed 19 5 18 7
Measure Type: Number
Unit of Measure: participants
16 1 10 4
7.Secondary Outcome
Title Change in CD4 Percent From Entry to Week 48
Hide Description Change was calculated as CD4 percent at week 48 minus entry CD4 percent (last CD4 percent before randomization date). Only subjects who reached 48 weeks of follow-up before DSMB decisions to unblind each Cohort were included in summary.
Time Frame 48 weeks if before date of DSMB decision to unblind Cohort results (Coh I: April 20, 2009; Coh II: October 27, 2010)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis uses intent to treat population. Change reported if subject followed at least 48 weeks before DSMB unblinding of results for each Cohort
Arm/Group Title Coh I: NVP Coh I: LPV/r Coh II: NVP Coh II: LPV/r
Hide Arm/Group Description:
Cohort I: Previously received single dose nevirapine (SD NVP). Randomly assigned to receive an NNRTI-based regimen.
Cohort I: Previously received SD NVP. Randomly assigned to receive a PI-based regimen.
Cohort II: Did not previously receive SD NVP. Randomly assigned to receive an NNRTI-based regimen
Cohort II: Did not previously receive SD NVP. Randomly assigned to receive a PI-based regimen
Overall Number of Participants Analyzed 63 70 109 119
Mean (95% Confidence Interval)
Unit of Measure: Percent of CD4
13.9
(11.6 to 16.2)
12.0
(10.3 to 13.7)
15.2
(13.6 to 16.9)
14.3
(13.0 to 15.7)
8.Secondary Outcome
Title Time From Randomization to HIV-related Disease Progression or Death
Hide Description HIV-related disease progression was defined as progression in WHO clinical stage from stage at entry or death. For subjects in WHO Stage IV at entry, disease progression was defined as death.
Time Frame Until date of DSMB decision to unblind Cohort results (Coh I: April 20, 2009 - median follow-up 48 weeks and range 0 - 125 weeks; Coh II: October 27, 2010 - median follow-up 72 weeks and range from 0 to 204 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis uses intent to treat population
Arm/Group Title Coh I: NVP Coh I: LPV/r Coh II: NVP Coh II: LPV/r
Hide Arm/Group Description:
Cohort I: Previously received single dose nevirapine (SD NVP). Randomly assigned to receive an NNRTI-based regimen.
Cohort I: Previously received SD NVP. Randomly assigned to receive a PI-based regimen.
Cohort II: Did not previously receive SD NVP. Randomly assigned to receive an NNRTI-based regimen
Cohort II: Did not previously receive SD NVP. Randomly assigned to receive a PI-based regimen
Overall Number of Participants Analyzed 82 82 147 140
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Weeks
5th percentile
11
(2 to 24)
2
(2 to 4)
8
(2 to 24)
35
(2 to 132)
10th percentile
17 [1] 
(5 to NA)
4
(2 to 24)
35 [2] 
(8 to NA)
132 [2] 
(35 to NA)
[1]
Not estimable as upper limit of survival function at all weeks above 90%
[2]
Not estimable as upper limit of survival function at all weeks above 98%
9.Secondary Outcome
Title Time From Randomization to Death
Hide Description Results report 2nd percentile of time from randomization to death
Time Frame Until date of DSMB decision to unblind Cohort results (Coh I: April 20, 2009 - median follow-up 48 weeks and range 0 - 125 weeks; Coh II: October 27, 2010 - median follow-up 72 weeks and range from 0 to 204 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis uses intent to treat population
Arm/Group Title Coh I: NVP Coh I: LPV/r Coh II: NVP Coh II: LPV/r
Hide Arm/Group Description:
Cohort I: Previously received single dose nevirapine (SD NVP). Randomly assigned to receive an NNRTI-based regimen.
Cohort I: Previously received SD NVP. Randomly assigned to receive a PI-based regimen.
Cohort II: Did not previously receive SD NVP. Randomly assigned to receive an NNRTI-based regimen
Cohort II: Did not previously receive SD NVP. Randomly assigned to receive a PI-based regimen
Overall Number of Participants Analyzed 82 82 147 140
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Weeks
11
(3 to 68)
3 [1] 
(2 to NA)
2
(2 to 12)
83 [1] 
(3 to NA)
[1]
Not estimable as upper limit for survival function at all weeks above 98%
Time Frame From study enrollment until study completion
Adverse Event Reporting Description Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and >=grade 3 AEs defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric AEs", V1.0, 12/2004.
 
Arm/Group Title Coh I: NVP Coh I: LPV/r Coh II: NVP Coh II: LPV/r
Hide Arm/Group Description Cohort II: Previously received single dose nevirapine (SD NVP). Randomly assigned to receive an NNRTI-based regimen. Cohort II: Previously received SD NVP. Randomly assigned to receive a PI-based regimen. Cohort II: Did not previously receive SD NVP. Randomly assigned to receive an NNRTI-based regimen. Cohort II: Did not previously receive SD NVP. Randomly assigned to receive a PI-based regimen.
All-Cause Mortality
Coh I: NVP Coh I: LPV/r Coh II: NVP Coh II: LPV/r
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   6/82 (7.32%)   3/82 (3.66%)   10/147 (6.80%)   6/140 (4.29%) 
Hide Serious Adverse Events
Coh I: NVP Coh I: LPV/r Coh II: NVP Coh II: LPV/r
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   23/82 (28.05%)   19/82 (23.17%)   65/147 (44.22%)   47/140 (33.57%) 
Blood and lymphatic system disorders         
Anaemia  1  1/82 (1.22%)  1/82 (1.22%)  3/147 (2.04%)  5/140 (3.57%) 
Neutropenia  1  12/82 (14.63%)  11/82 (13.41%)  24/147 (16.33%)  23/140 (16.43%) 
Thrombocytopenia  1  0/82 (0.00%)  0/82 (0.00%)  1/147 (0.68%)  2/140 (1.43%) 
Gastrointestinal disorders         
Diarrhoea  1  1/82 (1.22%)  1/82 (1.22%)  3/147 (2.04%)  1/140 (0.71%) 
Vomiting  1  0/82 (0.00%)  0/82 (0.00%)  0/147 (0.00%)  1/140 (0.71%) 
General disorders         
Death  1  2/82 (2.44%)  2/82 (2.44%)  2/147 (1.36%)  1/140 (0.71%) 
Pyrexia  1  0/82 (0.00%)  0/82 (0.00%)  1/147 (0.68%)  0/140 (0.00%) 
Immune system disorders         
Immunosuppression  1  0/82 (0.00%)  0/82 (0.00%)  2/147 (1.36%)  0/140 (0.00%) 
Infections and infestations         
Gastroenteritis  1  2/82 (2.44%)  0/82 (0.00%)  2/147 (1.36%)  3/140 (2.14%) 
Hepatitis A  1  0/82 (0.00%)  0/82 (0.00%)  1/147 (0.68%)  0/140 (0.00%) 
Malaria  1  0/82 (0.00%)  0/82 (0.00%)  6/147 (4.08%)  6/140 (4.29%) 
Measles  1  0/82 (0.00%)  0/82 (0.00%)  1/147 (0.68%)  1/140 (0.71%) 
Meningitis  1  0/82 (0.00%)  0/82 (0.00%)  1/147 (0.68%)  0/140 (0.00%) 
Pneumonia  1  3/82 (3.66%)  1/82 (1.22%)  10/147 (6.80%)  6/140 (4.29%) 
Sepsis  1  2/82 (2.44%)  0/82 (0.00%)  1/147 (0.68%)  0/140 (0.00%) 
Injury, poisoning and procedural complications         
Injury  1  1/82 (1.22%)  0/82 (0.00%)  0/147 (0.00%)  0/140 (0.00%) 
Investigations         
Alanine aminotransferase abnormal  1  0/82 (0.00%)  0/82 (0.00%)  1/147 (0.68%)  0/140 (0.00%) 
Alanine aminotransferase increased  1  1/82 (1.22%)  1/82 (1.22%)  4/147 (2.72%)  0/140 (0.00%) 
Blood cholesterol increased  1  0/82 (0.00%)  1/82 (1.22%)  0/147 (0.00%)  0/140 (0.00%) 
Haemoglobin decreased  1  1/82 (1.22%)  0/82 (0.00%)  1/147 (0.68%)  2/140 (1.43%) 
Hepatic enzyme increased  1  0/82 (0.00%)  0/82 (0.00%)  1/147 (0.68%)  1/140 (0.71%) 
Neutrophil count  1  1/82 (1.22%)  1/82 (1.22%)  2/147 (1.36%)  1/140 (0.71%) 
Neutrophil count decreased  1  1/82 (1.22%)  1/82 (1.22%)  9/147 (6.12%)  3/140 (2.14%) 
Transaminases increased  1  1/82 (1.22%)  0/82 (0.00%)  4/147 (2.72%)  0/140 (0.00%) 
Metabolism and nutrition disorders         
Hypokalaemia  1  0/82 (0.00%)  0/82 (0.00%)  2/147 (1.36%)  0/140 (0.00%) 
Lactic acidosis  1  0/82 (0.00%)  0/82 (0.00%)  1/147 (0.68%)  0/140 (0.00%) 
Nervous system disorders         
Headache  1  0/82 (0.00%)  0/82 (0.00%)  0/147 (0.00%)  1/140 (0.71%) 
Hypocalcaemic seizure  1  0/82 (0.00%)  0/82 (0.00%)  1/147 (0.68%)  0/140 (0.00%) 
Psychiatric disorders         
Breath holding  1  0/82 (0.00%)  0/82 (0.00%)  1/147 (0.68%)  0/140 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Bronchospasm  1  0/82 (0.00%)  1/82 (1.22%)  0/147 (0.00%)  0/140 (0.00%) 
Skin and subcutaneous tissue disorders         
Dermatitis  1  0/82 (0.00%)  0/82 (0.00%)  1/147 (0.68%)  0/140 (0.00%) 
Rash  1  0/82 (0.00%)  0/82 (0.00%)  1/147 (0.68%)  0/140 (0.00%) 
1
Term from vocabulary, MedDRA 19.1
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Coh I: NVP Coh I: LPV/r Coh II: NVP Coh II: LPV/r
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   81/82 (98.78%)   82/82 (100.00%)   146/147 (99.32%)   140/140 (100.00%) 
Blood and lymphatic system disorders         
Anaemia  1  0/82 (0.00%)  1/82 (1.22%)  9/147 (6.12%)  1/140 (0.71%) 
Iron deficiency anaemia  1  1/82 (1.22%)  3/82 (3.66%)  17/147 (11.56%)  13/140 (9.29%) 
Lymphadenopathy  1  2/82 (2.44%)  2/82 (2.44%)  19/147 (12.93%)  16/140 (11.43%) 
Neutropenia  1  3/82 (3.66%)  3/82 (3.66%)  18/147 (12.24%)  16/140 (11.43%) 
Ear and labyrinth disorders         
Otorrhoea  1  3/82 (3.66%)  0/82 (0.00%)  12/147 (8.16%)  4/140 (2.86%) 
Eye disorders         
Eye discharge  1  2/82 (2.44%)  3/82 (3.66%)  19/147 (12.93%)  13/140 (9.29%) 
Eye pruritus  1  0/82 (0.00%)  0/82 (0.00%)  8/147 (5.44%)  3/140 (2.14%) 
Ocular hyperaemia  1  1/82 (1.22%)  3/82 (3.66%)  19/147 (12.93%)  20/140 (14.29%) 
Gastrointestinal disorders         
Abdominal pain  1  1/82 (1.22%)  3/82 (3.66%)  16/147 (10.88%)  13/140 (9.29%) 
Aphthous ulcer  1  1/82 (1.22%)  4/82 (4.88%)  7/147 (4.76%)  12/140 (8.57%) 
Diarrhoea  1  13/82 (15.85%)  16/82 (19.51%)  50/147 (34.01%)  47/140 (33.57%) 
Stomatitis  1  1/82 (1.22%)  3/82 (3.66%)  8/147 (5.44%)  12/140 (8.57%) 
Vomiting  1  7/82 (8.54%)  6/82 (7.32%)  46/147 (31.29%)  33/140 (23.57%) 
General disorders         
Peripheral swelling  1  2/82 (2.44%)  1/82 (1.22%)  5/147 (3.40%)  8/140 (5.71%) 
Pyrexia  1  13/82 (15.85%)  17/82 (20.73%)  68/147 (46.26%)  68/140 (48.57%) 
Infections and infestations         
Acarodermatitis  1  16/82 (19.51%)  16/82 (19.51%)  14/147 (9.52%)  13/140 (9.29%) 
Body tinea  1  12/82 (14.63%)  10/82 (12.20%)  33/147 (22.45%)  31/140 (22.14%) 
Bronchiolitis  1  4/82 (4.88%)  5/82 (6.10%)  12/147 (8.16%)  8/140 (5.71%) 
Bronchitis  1  9/82 (10.98%)  11/82 (13.41%)  11/147 (7.48%)  10/140 (7.14%) 
Cellulitis  1  5/82 (6.10%)  3/82 (3.66%)  6/147 (4.08%)  6/140 (4.29%) 
Conjunctivitis  1  7/82 (8.54%)  13/82 (15.85%)  50/147 (34.01%)  42/140 (30.00%) 
Gastroenteritis  1  20/82 (24.39%)  23/82 (28.05%)  31/147 (21.09%)  24/140 (17.14%) 
Impetigo  1  17/82 (20.73%)  21/82 (25.61%)  26/147 (17.69%)  20/140 (14.29%) 
Malaria  1  5/82 (6.10%)  5/82 (6.10%)  33/147 (22.45%)  45/140 (32.14%) 
Measles  1  0/82 (0.00%)  4/82 (4.88%)  11/147 (7.48%)  2/140 (1.43%) 
Molluscum contagiosum  1  4/82 (4.88%)  5/82 (6.10%)  4/147 (2.72%)  5/140 (3.57%) 
Oral candidiasis  1  21/82 (25.61%)  20/82 (24.39%)  32/147 (21.77%)  22/140 (15.71%) 
Oral herpes  1  7/82 (8.54%)  2/82 (2.44%)  18/147 (12.24%)  11/140 (7.86%) 
Otitis externa  1  5/82 (6.10%)  0/82 (0.00%)  12/147 (8.16%)  11/140 (7.86%) 
Otitis media  1  15/82 (18.29%)  17/82 (20.73%)  38/147 (25.85%)  27/140 (19.29%) 
Otitis media acute  1  14/82 (17.07%)  9/82 (10.98%)  25/147 (17.01%)  10/140 (7.14%) 
Parotitis  1  2/82 (2.44%)  0/82 (0.00%)  5/147 (3.40%)  8/140 (5.71%) 
Persistent generalised lymphadenopathy  1  1/82 (1.22%)  3/82 (3.66%)  15/147 (10.20%)  16/140 (11.43%) 
Pharyngitis  1  17/82 (20.73%)  14/82 (17.07%)  32/147 (21.77%)  25/140 (17.86%) 
Plasmodium falciparum infection  1  3/82 (3.66%)  3/82 (3.66%)  34/147 (23.13%)  39/140 (27.86%) 
Pneumonia  1  18/82 (21.95%)  19/82 (23.17%)  42/147 (28.57%)  34/140 (24.29%) 
Pneumonia bacterial  1  2/82 (2.44%)  11/82 (13.41%)  27/147 (18.37%)  22/140 (15.71%) 
Pulmonary tuberculosis  1  12/82 (14.63%)  15/82 (18.29%)  15/147 (10.20%)  5/140 (3.57%) 
Purulent discharge  1  1/82 (1.22%)  1/82 (1.22%)  7/147 (4.76%)  8/140 (5.71%) 
Subcutaneous abscess  1  2/82 (2.44%)  5/82 (6.10%)  3/147 (2.04%)  6/140 (4.29%) 
Tinea capitis  1  19/82 (23.17%)  33/82 (40.24%)  55/147 (37.41%)  54/140 (38.57%) 
Tinea faciei  1  8/82 (9.76%)  1/82 (1.22%)  8/147 (5.44%)  6/140 (4.29%) 
Tinea infection  1  12/82 (14.63%)  11/82 (13.41%)  29/147 (19.73%)  20/140 (14.29%) 
Tonsillitis  1  19/82 (23.17%)  19/82 (23.17%)  27/147 (18.37%)  27/140 (19.29%) 
Varicella  1  7/82 (8.54%)  9/82 (10.98%)  13/147 (8.84%)  9/140 (6.43%) 
Investigations         
Alanine aminotransferase  1  9/82 (10.98%)  4/82 (4.88%)  21/147 (14.29%)  8/140 (5.71%) 
Alanine aminotransferase increased  1  44/82 (53.66%)  34/82 (41.46%)  62/147 (42.18%)  43/140 (30.71%) 
Aspartate aminotransferase  1  7/82 (8.54%)  5/82 (6.10%)  13/147 (8.84%)  6/140 (4.29%) 
Aspartate aminotransferase increased  1  51/82 (62.20%)  39/82 (47.56%)  58/147 (39.46%)  54/140 (38.57%) 
Blood cholesterol increased  1  3/82 (3.66%)  11/82 (13.41%)  11/147 (7.48%)  14/140 (10.00%) 
Blood triglycerides increased  1  1/82 (1.22%)  6/82 (7.32%)  8/147 (5.44%)  4/140 (2.86%) 
Haemoglobin decreased  1  57/82 (69.51%)  60/82 (73.17%)  126/147 (85.71%)  113/140 (80.71%) 
Neutrophil count decreased  1  54/82 (65.85%)  54/82 (65.85%)  105/147 (71.43%)  113/140 (80.71%) 
Platelet count decreased  1  3/82 (3.66%)  8/82 (9.76%)  19/147 (12.93%)  23/140 (16.43%) 
Weight decreased  1  2/82 (2.44%)  5/82 (6.10%)  18/147 (12.24%)  21/140 (15.00%) 
Metabolism and nutrition disorders         
Decreased appetite  1  2/82 (2.44%)  9/82 (10.98%)  32/147 (21.77%)  36/140 (25.71%) 
Failure to thrive  1  7/82 (8.54%)  11/82 (13.41%)  13/147 (8.84%)  8/140 (5.71%) 
Kwashiorkor  1  5/82 (6.10%)  0/82 (0.00%)  5/147 (3.40%)  4/140 (2.86%) 
Malnutrition  1  0/82 (0.00%)  0/82 (0.00%)  1/147 (0.68%)  8/140 (5.71%) 
Musculoskeletal and connective tissue disorders         
Pain in extremity  1  0/82 (0.00%)  1/82 (1.22%)  8/147 (5.44%)  6/140 (4.29%) 
Nervous system disorders         
Headache  1  2/82 (2.44%)  0/82 (0.00%)  10/147 (6.80%)  10/140 (7.14%) 
Respiratory, thoracic and mediastinal disorders         
Bronchial hyperreactivity  1  0/82 (0.00%)  1/82 (1.22%)  8/147 (5.44%)  4/140 (2.86%) 
Cough  1  12/82 (14.63%)  14/82 (17.07%)  61/147 (41.50%)  60/140 (42.86%) 
Dyspnoea  1  4/82 (4.88%)  2/82 (2.44%)  13/147 (8.84%)  7/140 (5.00%) 
Pharyngeal erythema  1  1/82 (1.22%)  2/82 (2.44%)  9/147 (6.12%)  7/140 (5.00%) 
Pharyngeal inflammation  1  1/82 (1.22%)  4/82 (4.88%)  22/147 (14.97%)  20/140 (14.29%) 
Rhinorrhoea  1  4/82 (4.88%)  9/82 (10.98%)  52/147 (35.37%)  48/140 (34.29%) 
Tonsillar hypertrophy  1  0/82 (0.00%)  2/82 (2.44%)  10/147 (6.80%)  9/140 (6.43%) 
Wheezing  1  1/82 (1.22%)  1/82 (1.22%)  6/147 (4.08%)  10/140 (7.14%) 
Skin and subcutaneous tissue disorders         
Dermatitis allergic  1  3/82 (3.66%)  2/82 (2.44%)  17/147 (11.56%)  6/140 (4.29%) 
Eczema  1  10/82 (12.20%)  10/82 (12.20%)  20/147 (13.61%)  15/140 (10.71%) 
Papule  1  1/82 (1.22%)  4/82 (4.88%)  17/147 (11.56%)  32/140 (22.86%) 
Pruritus  1  1/82 (1.22%)  3/82 (3.66%)  13/147 (8.84%)  15/140 (10.71%) 
Rash  1  24/82 (29.27%)  31/82 (37.80%)  86/147 (58.50%)  72/140 (51.43%) 
Rash generalised  1  11/82 (13.41%)  6/82 (7.32%)  28/147 (19.05%)  13/140 (9.29%) 
Rash papular  1  8/82 (9.76%)  8/82 (9.76%)  29/147 (19.73%)  42/140 (30.00%) 
Seborrhoeic dermatitis  1  11/82 (13.41%)  14/82 (17.07%)  7/147 (4.76%)  8/140 (5.71%) 
Skin lesion  1  5/82 (6.10%)  6/82 (7.32%)  18/147 (12.24%)  20/140 (14.29%) 
Skin plaque  1  0/82 (0.00%)  0/82 (0.00%)  5/147 (3.40%)  8/140 (5.71%) 
Skin reaction  1  4/82 (4.88%)  0/82 (0.00%)  8/147 (5.44%)  1/140 (0.71%) 
Skin ulcer  1  2/82 (2.44%)  5/82 (6.10%)  16/147 (10.88%)  19/140 (13.57%) 
Swelling face  1  5/82 (6.10%)  0/82 (0.00%)  0/147 (0.00%)  7/140 (5.00%) 
Urticaria  1  0/82 (0.00%)  1/82 (1.22%)  8/147 (5.44%)  1/140 (0.71%) 
Vascular disorders         
Pallor  1  1/82 (1.22%)  0/82 (0.00%)  8/147 (5.44%)  1/140 (0.71%) 
1
Term from vocabulary, MedDRA 19.1
Indicates events were collected by systematic assessment
Accrual to Cohort I was terminated early by the Data Safety Monitoring Committee after enrollment of 164 of the planned 288 subjects.
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 Trial 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 manuscript and five (5) business days for abstracts, to preserve U.S. or foreign patent or other intellectual property rights.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Melissa Allen, Director, IMPAACT Operations Center
Organization: Family Health International (FHI 360)
Phone: (919) 405-1429
EMail: mallen@fhi360.org
Publications of Results:
Palumbo P, Violari A, Lindsey J, Hughes M, Jean-Philippe P, Mofenson L, Purdue L, Eshleman S for the IMPAACT P1060 Study Team. Nevirapine vs Lopinavir-ritonavir-based antiretroviral therapy in single dose Nevirapine-exposed HIV-infected infants: preliminary results from the IMPAACT P1060 Trial. 5th IAS Conference on HIV Pathogenesis, Treatment and Prevention, Capetown, July, 2009.
Palumbo P, Violari A, Lindsey J, Hughes M, Jean-Philippe P, Mofenson L, Bwakura-Dangarembizi M, Kamthunzi P, Eshleman S and Prudue L for the IMPAACT P1060 Team. Nevirapine (NVP)-vs. Lopinavir-Ritonavir (LPV/r)-based antiretroviral therapy (ART) among HIV-infected infants in resource-limited settings: The IMPAACT P1060 Trial. 18th Conference on Retroviruses and Opportunistic Infections, Boston, February, 2011.
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: International Maternal Pediatric Adolescent AIDS Clinical Trials Group
ClinicalTrials.gov Identifier: NCT00307151    
Other Study ID Numbers: IMPAACT P1060
U01AI068632 ( U.S. NIH Grant/Contract )
First Submitted: March 24, 2006
First Posted: March 27, 2006
Results First Submitted: July 5, 2011
Results First Posted: August 3, 2011
Last Update Posted: April 13, 2017