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Trial record 18 of 3101 for:    HIV Infections | NIH

Anti-HIV Drug Regimens and Treatment-Switching Guidelines in HIV Infected Children

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: NCT00039741
Recruitment Status : Completed
First Posted : June 11, 2002
Results First Posted : April 24, 2012
Last Update Posted : February 7, 2019
Sponsor:
Collaborators:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
PENTA Foundation
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Factorial Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition HIV Infections
Interventions Drug: NRTIs (ABC, FTC, FTC/TDF, 3TC, 3TC/AZT, d4T, TDF, ddC, AZT)
Drug: NNRTIs (EFV, NVP)
Drug: PIs (AMP, IDV, LPV/r, NFV, SQV, RTV)
Enrollment 266
Recruitment Details Recruited at Pediatric AIDS Clinical Trials Group (PACTG) units in the U.S. and Puerto Rico, and Paediatric European Network for Treatment of AIDS (PENTA) units in Argentina, Austria, the Bahamas, Brazil, France, Germany, Italy, Romania, Spain, the United Kingdom and Ireland. Enrollment started 9/25/02 and ended 9/7/05.
Pre-assignment Details Participants were stratified by age (<3 years versus 3+ years), origin (PACTG site or PENTA site), and exposure versus no exposure to antiretroviral therapy perinatally. 266 children were randomized, of whom 3 are excluded from all analyses (2 had consent withdrawn by parents after randomization, 1 was ineligible).
Arm/Group Title PI/1K NNRTI/1K PI/30K NNRTI/30K
Hide Arm/Group Description Two nucleoside reverse transcriptase inhibitors (NRTI) plus a protease inhibitor (PI)with a regimen change recommended when viral load is 1000 copies/ml or higher 2 NRTIs plus a nonnucleoside reverse transcriptase inhibitor (NNRTI) with a regimen change recommended when viral load reaches 1,000 copies/ml or higher Two NRTIs plus a PIwith a regimen change recommended when viral load is 30,000 copies/ml or higher 2 NRTIs plus an NNRTI with a regimen change recommended when viral load reaches 30,000 copies/ml or higher
Period Title: Overall Study
Started 66 68 65 64
Death 0 1 0 0
Completed 51 56 54 50
Not Completed 15 12 11 14
Reason Not Completed
Death             0             1             0             0
Lost to Follow-up             3             1             5             2
Confounding medical condition             1             0             0             0
Not able to get to clinic             5             2             0             3
Moved             3             2             3             6
Non-compliance with protocol             1             0             1             0
Withdrew consent             0             5             0             1
Missed final visit             2             1             2             2
Arm/Group Title PI/1K NNRTI/1K PI/30K NNRTI/30K Total
Hide Arm/Group Description Two nucleoside reverse transcriptase inhibitors (NRTI) plus a protease inhibitor (PI)with a regimen change recommended when viral load is 1000 copies/ml or higher 2 NRTIs plus a nonnucleoside reverse transcriptase inhibitor (NNRTI) with a regimen change recommended when viral load reaches 1,000 copies/ml or higher Two NRTIs plus a PIwith a regimen change recommended when viral load is 30,000 copies/ml or higher 2 NRTIs plus an NNRTI with a regimen change recommended when viral load reaches 30,000 copies/ml or higher Total of all reporting groups
Overall Number of Baseline Participants 66 68 65 64 263
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 66 participants 68 participants 65 participants 64 participants 263 participants
8.0  (5.7) 7.0  (5.4) 7.9  (5.4) 6.9  (5.0) 7.5  (5.4)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 66 participants 68 participants 65 participants 64 participants 263 participants
>30 days to <=12 months 10 12 7 11 40
>12 months to <=3 years 8 7 8 5 28
>3 to <=9 years 19 27 24 29 99
>9 to <=14 years 14 13 13 10 50
>14 years to <18 years 15 9 13 9 46
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 66 participants 68 participants 65 participants 64 participants 263 participants
Female
30
  45.5%
33
  48.5%
32
  49.2%
32
  50.0%
127
  48.3%
Male
36
  54.5%
35
  51.5%
33
  50.8%
32
  50.0%
136
  51.7%
Region of Enrollment   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 66 participants 68 participants 65 participants 64 participants 263 participants
United States 18 20 16 18 72
Puerto Rico 1 1 1 0 3
Argentina 1 4 3 3 11
Austria 1 0 0 1 2
Bahamas 2 0 2 0 4
Brazil 12 11 9 9 41
France 3 3 5 6 17
Germany 5 6 3 7 21
Italy 7 4 5 6 22
Romania 8 7 9 7 31
Spain 1 0 1 0 2
United Kingdom 7 11 9 6 33
Ireland 0 1 2 1 4
[1]
Measure Description: Sites in the US and Puerto Rico were enrolled through PACTG, and other sites were enrolled through PENTA
Viral Load   [1] 
Mean (Standard Deviation)
Unit of measure:  Log10 copies/ml
Number Analyzed 66 participants 68 participants 65 participants 64 participants 263 participants
5.2  (0.8) 5.0  (0.8) 5.0  (0.8) 5.1  (0.8) 5.1  (0.8)
[1]
Measure Description: Log10 HIV-1 RNA (copies/ml)
PENTA/PACTG site  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 66 participants 68 participants 65 participants 64 participants 263 participants
PENTA 47 47 48 46 188
PACTG 19 21 17 18 75
CD4 percent (percentage of total lymphocytes that are CD4 cells)  
Mean (Standard Deviation)
Unit of measure:  CD4%
Number Analyzed 66 participants 68 participants 65 participants 64 participants 263 participants
18  (12) 18  (10) 18  (11) 17  (12) 18  (11)
1.Primary Outcome
Title Change in Viral Load Measured in log10 HIV-1 RNA Copies/ml
Hide Description [Not Specified]
Time Frame Baseline visit and 4 years after Study Entry
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat analyses for those subjects who had data at baseline and 4 years. Analyses were done by collapsing groups to examine drug class (regardless of switch point) and switch point (regardless of drug class).
Arm/Group Title Drug Class/PI Drug Class/NNRTI Switch Point (1K) Switch Point (30K)
Hide Arm/Group Description:
Participants randomized to receive a PI-based regimen, regardless of switch point.
Participants randomized to receive an NNRTI-based regimen, regardless of switch point.
Participants randomized to switch to second-line therapy when HIV-1 RNA is >=1,000 copies/mL, regardless of drug class.
Participants randomized to switch to second-line therapy when HIV-1 RNA is >=30,000 copies/mL, regardless of drug class.
Overall Number of Participants Analyzed 118 116 117 117
Mean (Standard Error)
Unit of Measure: log10 HIV-1 RNA
-3.16  (0.09) -3.31  (0.09) -3.26  (0.09) -3.20  (0.09)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Drug Class/PI, Drug Class/NNRTI
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.26
Comments [Not Specified]
Method Interval regression
Comments Adjusted for baseline HIV-1 RNA, age (<3 years vs 3 years), origin (PACTG vs PENTA sites), and perinatal ART exposure versus no exposure.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.15
Confidence Interval (2-Sided) 95%
-0.41 to 0.11
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.13
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Switch Point (1K), Switch Point (30K)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.56
Comments [Not Specified]
Method Interval regression
Comments Adjusted for baseline HIV-1 RNA, age (<3 years vs 3 years), origin (PACTG vs PENTA sites), and perinatal ART exposure versus no exposure.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.06
Confidence Interval (2-Sided) 95%
-0.20 to 0.32
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.13
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Rate of Grade 3 or Higher Signs, Symptoms, or Laboratory Abnormalities Experienced
Hide Description

Adverse events were graded according to the following guidelines:

PACTG: “The Manual for Expedited Reporting of Adverse Events to DAIDS” (DAIDS EAE Manual) dated May 6, 2004.

PENTA: International Conference for Harmonization (ICH) requirements and the EU Clinical Trials Directive 2001/20/EC (20).

A rating of Grade 3 is severe and Grade 4 is life-threatening. The rate of serious (Grade 3 or above)events is reported as the number of events per 100 child/years.

Time Frame Up to 6 yrs. (average 4.85 yrs.)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat
Arm/Group Title Drug Class/PI Drug Class/NNRTI Switch Point (1K) Switch Point (30K)
Hide Arm/Group Description:
Participants randomized to receive a PI-based regimen, regardless of switch point.
Participants randomized to receive an NNRTI-based regimen, regardless of switch point.
Participants randomized to switch to second-line therapy when HIV-1 RNA is >=1,000 copies/mL, regardless of drug class.
Participants randomized to switch to second-line therapy when HIV-1 RNA is >=30,000 copies/mL, regardless of drug class.
Overall Number of Participants Analyzed 131 132 134 129
Mean (95% Confidence Interval)
Unit of Measure: events/100 child-years
0.16
(0.08 to 0.31)
0.17
(0.09 to 0.31)
0.16
(0.08 to 0.31)
0.17
(0.09 to 0.31)
3.Secondary Outcome
Title Participants With Significant HIV-related Clinical Events, Defined as CDC Category C (AIDS Defining) Diagnoses (Except for Recurrent Bacterial Infections)or Death
Hide Description [Not Specified]
Time Frame Up to 6 yrs. (average 4.85 yrs.)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat
Arm/Group Title Drug Class/PI Drug Class/NNRTI Switch Point (1K) Switch Point (30K)
Hide Arm/Group Description:
Participants randomized to receive a PI-based regimen, regardless of switch point.
Participants randomized to receive an NNRTI-based regimen, regardless of switch point.
Participants randomized to switch to second-line therapy when HIV-1 RNA is >=1,000 copies/mL, regardless of drug class.
Participants randomized to switch to second-line therapy when HIV-1 RNA is >=30,000 copies/mL, regardless of drug class.
Overall Number of Participants Analyzed 131 132 134 129
Measure Type: Number
Unit of Measure: participants
6 4 5 5
4.Secondary Outcome
Title Time to Switching to an Alternative Class ART Regimen (Based on Initial Randomized Regimen)
Hide Description 25th Percentiles in weeks from randomization to starting an alternative class ART regimen (based on initial randomized regimen)
Time Frame Up to 6 yrs. (average 4.85 yrs.)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat
Arm/Group Title Drug Class/PI Drug Class/NNRTI Switch Point (1K) Switch Point (30K)
Hide Arm/Group Description:
Participants randomized to receive a PI-based regimen, regardless of switch point.
Participants randomized to receive an NNRTI-based regimen, regardless of switch point.
Participants randomized to switch to second-line therapy when HIV-1 RNA is >=1,000 copies/mL, regardless of drug class.
Participants randomized to switch to second-line therapy when HIV-1 RNA is >=30,000 copies/mL, regardless of drug class.
Overall Number of Participants Analyzed 131 132 134 129
Median (Inter-Quartile Range)
Unit of Measure: Weeks (25th Percentile)
NA [1] 
(295 to NA)
NA [1] 
(142 to NA)
NA [1] 
(142 to NA)
NA [1] 
(240 to NA)
[1]
Fewer than 50% of participants reached the switching criteria, so the median and 75th percentile are undefined.
5.Secondary Outcome
Title Time to HIV-1 RNA of 400 Copies/ml or Greater During First-line Therapy or Permanent Discontinuation of First-line Therapy
Hide Description 25th Percentiles in weeks from randomization HIV-1 RNA of 400 copies/ml or greater during first-line therapy or permanent discontinuation of first-line therapy.
Time Frame Up to 6 yrs. (average 4.85 yrs.)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat
Arm/Group Title Drug Class/PI Drug Class/NNRTI Switch Point (1K) Switch Point (30K)
Hide Arm/Group Description:
Participants randomized to receive a PI-based regimen, regardless of switch point.
Participants randomized to receive an NNRTI-based regimen, regardless of switch point.
Participants randomized to switch to second-line therapy when HIV-1 RNA is >=1,000 copies/mL, regardless of drug class.
Participants randomized to switch to second-line therapy when HIV-1 RNA is >=30,000 copies/mL, regardless of drug class.
Overall Number of Participants Analyzed 131 132 134 129
Measure Type: Number
Unit of Measure: Weeks (25th Percentile)
36 68 41 72
6.Secondary Outcome
Title Time to HIV-1 RNA of 30,000 Copies/ml or Greater During Second-line Therapy or Permanent Discontinuation of Second-line Therapy
Hide Description 25th Percentiles in weeks from randomization to HIV-1 RNA of 30,000 copies/ml or greater during second-line therapy or permanent discontinuation of second-line therapy
Time Frame Up to 6 yrs. (average 4.85 yrs.)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat
Arm/Group Title Drug Class/PI Drug Class/NNRTI Switch Point (1K) Switch Point (30K)
Hide Arm/Group Description:
Participants randomized to receive a PI-based regimen, regardless of switch point.
Participants randomized to receive an NNRTI-based regimen, regardless of switch point.
Participants randomized to switch to second-line therapy when HIV-1 RNA is >=1,000 copies/mL, regardless of drug class.
Participants randomized to switch to second-line therapy when HIV-1 RNA is >=30,000 copies/mL, regardless of drug class.
Overall Number of Participants Analyzed 28 32 37 23
Measure Type: Number
Unit of Measure: Weeks (25th Percentile)
126 267 267 228
7.Secondary Outcome
Title Number of Children With an HIV-1 RNA Level Less Than 400 Copies/ml Regardless of Therapy at Week 204
Hide Description [Not Specified]
Time Frame Week 204
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat. Numbers are reported among participants who had an HIV-1 RNA value and were in follow-up at week 204.
Arm/Group Title Drug Class/PI Drug Class/NNRTI Switch Point (1K) Switch Point (30K)
Hide Arm/Group Description:
Participants randomized to receive a PI-based regimen, regardless of switch point.
Participants randomized to receive an NNRTI-based regimen, regardless of switch point.
Participants randomized to switch to second-line therapy when HIV-1 RNA is >=1,000 copies/mL, regardless of drug class.
Participants randomized to switch to second-line therapy when HIV-1 RNA is >=30,000 copies/mL, regardless of drug class.
Overall Number of Participants Analyzed 112 114 114 112
Measure Type: Number
Unit of Measure: participants
92 93 95 90
8.Secondary Outcome
Title Change in CD4% From Randomization to 4 Years
Hide Description [Not Specified]
Time Frame Randomization to 4 years
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat, for participants who had CD4% values available at 4 years and at baseline.
Arm/Group Title Drug Class/PI Drug Class/NNRTI Switch Point (1K) Switch Point (30K)
Hide Arm/Group Description:
Participants randomized to receive a PI-based regimen, regardless of switch point.
Participants randomized to receive an NNRTI-based regimen, regardless of switch point.
Participants randomized to switch to second-line therapy when HIV-1 RNA is >=1,000 copies/mL, regardless of drug class.
Participants randomized to switch to second-line therapy when HIV-1 RNA is >=30,000 copies/mL, regardless of drug class.
Overall Number of Participants Analyzed 131 132 134 129
Mean (Standard Deviation)
Unit of Measure: CD4 percent (% of total lymphocytes)
13.7  (0.8) 15.2  (0.8) 15.1  (0.8) 13.9  (0.8)
9.Secondary Outcome
Title Number of Children With HIV-1 RNA Less Than 400 Copies/ml and on Original Randomized Therapy at 24 Weeks
Hide Description [Not Specified]
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat - numbers are reported among participants who had an HIV-1 RNA value and were in follow-up at week 24.
Arm/Group Title Drug Class/PI Drug Class/NNRTI Switch Point (1K) Switch Point (30K)
Hide Arm/Group Description:
Participants randomized to receive a PI-based regimen, regardless of switch point.
Participants randomized to receive an NNRTI-based regimen, regardless of switch point.
Participants randomized to switch to second-line therapy when HIV-1 RNA is >=1,000 copies/mL, regardless of drug class.
Participants randomized to switch to second-line therapy when HIV-1 RNA is >=30,000 copies/mL, regardless of drug class.
Overall Number of Participants Analyzed 130 129 132 127
Measure Type: Number
Unit of Measure: participants
92 98 99 91
Time Frame Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events.
Adverse Event Reporting Description Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.
 
Arm/Group Title PI/1K NNRTI/1K PI/30K NNRTI/30K
Hide Arm/Group Description Two nucleoside reverse transcriptase inhibitors (NRTI) plus a protease inhibitor (PI)with a regimen change recommended when viral load is 1000 copies/ml or higher 2 NRTIs plus a nonnucleoside reverse transcriptase inhibitor (NNRTI) with a regimen change recommended when viral load reaches 1,000 copies/ml or higher Two NRTIs plus a PIwith a regimen change recommended when viral load is 30,000 copies/ml or higher 2 NRTIs plus an NNRTI with a regimen change recommended when viral load reaches 30,000 copies/ml or higher
All-Cause Mortality
PI/1K NNRTI/1K PI/30K NNRTI/30K
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
PI/1K NNRTI/1K PI/30K NNRTI/30K
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   9/66 (13.64%)      10/68 (14.71%)      14/65 (21.54%)      15/64 (23.44%)    
Blood and lymphatic system disorders         
Anemia  1  1/66 (1.52%)  1 0/68 (0.00%)  0 0/65 (0.00%)  0 1/64 (1.56%)  1
Anemia megaloblastic  1  0/66 (0.00%)  0 0/68 (0.00%)  0 1/65 (1.54%)  1 0/64 (0.00%)  0
Aplastic anemia  1  0/66 (0.00%)  0 0/68 (0.00%)  0 0/65 (0.00%)  0 1/64 (1.56%)  1
Lymphadenitis  1  0/66 (0.00%)  0 0/68 (0.00%)  0 0/65 (0.00%)  0 1/64 (1.56%)  1
Thrombocytopenia  1  0/66 (0.00%)  0 0/68 (0.00%)  0 1/65 (1.54%)  1 0/64 (0.00%)  0
Ear and labyrinth disorders         
Vertigo  1  1/66 (1.52%)  1 0/68 (0.00%)  0 0/65 (0.00%)  0 0/64 (0.00%)  0
Eye disorders         
Retinal detachment  1  0/66 (0.00%)  0 0/68 (0.00%)  0 0/65 (0.00%)  0 1/64 (1.56%)  1
Uveitis  1  0/66 (0.00%)  0 0/68 (0.00%)  0 0/65 (0.00%)  0 1/64 (1.56%)  1
Progressive external ophthalmoplegia  1  0/66 (0.00%)  0 0/68 (0.00%)  0 0/65 (0.00%)  0 1/64 (1.56%)  1
Gastrointestinal disorders         
Abdominal pain  1  1/66 (1.52%)  1 0/68 (0.00%)  0 0/65 (0.00%)  0 1/64 (1.56%)  1
Constipation  1  0/66 (0.00%)  0 1/68 (1.47%)  1 0/65 (0.00%)  0 0/64 (0.00%)  0
Diarrhea  1  0/66 (0.00%)  0 0/68 (0.00%)  0 1/65 (1.54%)  1 1/64 (1.56%)  1
Diarrhea, viral  1  0/66 (0.00%)  0 0/68 (0.00%)  0 0/65 (0.00%)  0 1/64 (1.56%)  1
Food poisoning  1  0/66 (0.00%)  0 0/68 (0.00%)  0 0/65 (0.00%)  0 1/64 (1.56%)  1
Gastointestinal disorder  1  0/66 (0.00%)  0 0/68 (0.00%)  0 1/65 (1.54%)  1 0/64 (0.00%)  0
Pancreatitis  1  1/66 (1.52%)  1 0/68 (0.00%)  0 0/65 (0.00%)  0 0/64 (0.00%)  0
Vomiting  1  1/66 (1.52%)  1 0/68 (0.00%)  0 1/65 (1.54%)  1 2/64 (3.13%)  2
General disorders         
Drug intolerance  1  0/66 (0.00%)  0 0/68 (0.00%)  0 0/65 (0.00%)  0 1/64 (1.56%)  1
Pyrexia  1  0/66 (0.00%)  0 1/68 (1.47%)  1 0/65 (0.00%)  0 0/64 (0.00%)  0
Systemic inflammatory response syndrome  1  0/66 (0.00%)  0 0/68 (0.00%)  0 1/65 (1.54%)  1 0/64 (0.00%)  0
Hepatobiliary disorders         
Biliary dyskinesia  1  0/66 (0.00%)  0 0/68 (0.00%)  0 0/65 (0.00%)  0 1/64 (1.56%)  1
Immune system disorders         
Drug hypersensitivity  1  0/66 (0.00%)  0 0/68 (0.00%)  0 1/65 (1.54%)  1 0/64 (0.00%)  0
Erythema nodosum  1  0/66 (0.00%)  0 0/68 (0.00%)  0 0/65 (0.00%)  0 1/64 (1.56%)  1
Hypersensitivity  1  1/66 (1.52%)  1 0/68 (0.00%)  0 1/65 (1.54%)  1 0/64 (0.00%)  0
Infections and infestations         
Appendicitis, perforated  1  0/66 (0.00%)  0 1/68 (1.47%)  1 0/65 (0.00%)  0 0/64 (0.00%)  0
Arthritis, viral  1  0/66 (0.00%)  0 0/68 (0.00%)  0 0/65 (0.00%)  0 1/64 (1.56%)  1
Bacterial pyelonephritis  1  0/66 (0.00%)  0 1/68 (1.47%)  1 0/65 (0.00%)  0 0/64 (0.00%)  0
Dengue fever  1  0/66 (0.00%)  0 0/68 (0.00%)  0 1/65 (1.54%)  1 1/64 (1.56%)  1
Escherichia  1  0/66 (0.00%)  0 0/68 (0.00%)  0 1/65 (1.54%)  1 0/64 (0.00%)  0
Gastroenteritis rotavirus  1  1/66 (1.52%)  1 0/68 (0.00%)  0 0/65 (0.00%)  0 0/64 (0.00%)  0
Implant site cellulitis  1  0/66 (0.00%)  0 0/68 (0.00%)  0 0/65 (0.00%)  0 1/64 (1.56%)  1
Laryngitis, viral  1  1/66 (1.52%)  1 0/68 (0.00%)  0 0/65 (0.00%)  0 0/64 (0.00%)  0
Mastoiditis  1  0/66 (0.00%)  0 0/68 (0.00%)  0 1/65 (1.54%)  1 0/64 (0.00%)  0
Esophageal candidiasis  1  0/66 (0.00%)  0 0/68 (0.00%)  0 1/65 (1.54%)  1 0/64 (0.00%)  0
Pelvic inflammatory disease  1  1/66 (1.52%)  1 0/68 (0.00%)  0 0/65 (0.00%)  0 0/64 (0.00%)  0
Pneumonia  1  0/66 (0.00%)  0 1/68 (1.47%)  1 0/65 (0.00%)  0 1/64 (1.56%)  1
Respiratory syncytial virus bronchiolitis  1  0/66 (0.00%)  0 0/68 (0.00%)  0 1/65 (1.54%)  1 0/64 (0.00%)  0
Tonsilitis  1  0/66 (0.00%)  0 0/68 (0.00%)  0 0/65 (0.00%)  0 1/64 (1.56%)  1
Urinary tract infection  1  1/66 (1.52%)  1 0/68 (0.00%)  0 1/65 (1.54%)  1 2/64 (3.13%)  2
Injury, poisoning and procedural complications         
Concussion  1  0/66 (0.00%)  0 0/68 (0.00%)  0 1/65 (1.54%)  1 0/64 (0.00%)  0
Joint sprain  1  0/66 (0.00%)  0 0/68 (0.00%)  0 0/65 (0.00%)  0 1/64 (1.56%)  1
Investigations         
Alanine aminotransferase increased  1  1/66 (1.52%)  1 1/68 (1.47%)  1 1/65 (1.54%)  1 0/64 (0.00%)  0
Aspartate aminotransferase increased  1  1/66 (1.52%)  1 0/68 (0.00%)  0 1/65 (1.54%)  1 0/64 (0.00%)  0
Blood creatine phosphkinase increased  1  0/66 (0.00%)  0 0/68 (0.00%)  0 1/65 (1.54%)  1 0/64 (0.00%)  0
Musculoskeletal and connective tissue disorders         
Myopathy  1  0/66 (0.00%)  0 0/68 (0.00%)  0 0/65 (0.00%)  0 1/64 (1.56%)  1
Myositis  1  0/66 (0.00%)  0 0/68 (0.00%)  0 1/65 (1.54%)  1 0/64 (0.00%)  0
Nervous system disorders         
Epilepsy  1  0/66 (0.00%)  0 1/68 (1.47%)  1 0/65 (0.00%)  0 0/64 (0.00%)  0
Hypotonia  1  0/66 (0.00%)  0 1/68 (1.47%)  1 0/65 (0.00%)  0 0/64 (0.00%)  0
Myasthenia gravis  1  0/66 (0.00%)  0 1/68 (1.47%)  1 0/65 (0.00%)  0 0/64 (0.00%)  0
Pregnancy, puerperium and perinatal conditions         
Pre-eclampsia  1  1/66 (1.52%)  1 0/68 (0.00%)  0 0/65 (0.00%)  0 0/64 (0.00%)  0
Psychiatric disorders         
Generalized anxiety disorder  1  0/66 (0.00%)  0 0/68 (0.00%)  0 0/65 (0.00%)  0 1/64 (1.56%)  1
Major depression  1  0/66 (0.00%)  0 1/68 (1.47%)  1 0/65 (0.00%)  0 0/64 (0.00%)  0
Panic disorder  1  0/66 (0.00%)  0 0/68 (0.00%)  0 0/65 (0.00%)  0 1/64 (1.56%)  1
Psychotic disorder  1  0/66 (0.00%)  0 0/68 (0.00%)  0 0/65 (0.00%)  0 1/64 (1.56%)  1
Schizophrenia  1  0/66 (0.00%)  0 0/68 (0.00%)  0 0/65 (0.00%)  0 1/64 (1.56%)  1
Suicide attempt  1  0/66 (0.00%)  0 1/68 (1.47%)  1 0/65 (0.00%)  0 0/64 (0.00%)  0
Renal and urinary disorders         
Acute renal failure  1  0/66 (0.00%)  0 0/68 (0.00%)  0 1/65 (1.54%)  1 0/64 (0.00%)  0
Reproductive system and breast disorders         
Ovarian cyst  1  0/66 (0.00%)  0 0/68 (0.00%)  0 1/65 (1.54%)  1 0/64 (0.00%)  0
Respiratory, thoracic and mediastinal disorders         
Acute sinusitis  1  0/66 (0.00%)  0 0/68 (0.00%)  0 1/65 (1.54%)  1 0/64 (0.00%)  0
Bronchial hyperreactivity  1  0/66 (0.00%)  0 0/68 (0.00%)  0 0/65 (0.00%)  0 1/64 (1.56%)  1
Croup, infectious  1  0/66 (0.00%)  0 0/68 (0.00%)  0 1/65 (1.54%)  1 0/64 (0.00%)  0
Dyspnea  1  0/66 (0.00%)  0 2/68 (2.94%)  2 0/65 (0.00%)  0 0/64 (0.00%)  0
Skin and subcutaneous tissue disorders         
Drug eruption  1  0/66 (0.00%)  0 0/68 (0.00%)  0 0/65 (0.00%)  0 1/64 (1.56%)  1
Rash, maculo-papular  1  0/66 (0.00%)  0 1/68 (1.47%)  1 0/65 (0.00%)  0 1/64 (1.56%)  1
Vascular disorders         
Vasculitis  1  0/66 (0.00%)  0 0/68 (0.00%)  0 0/65 (0.00%)  0 1/64 (1.56%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (12.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
PI/1K NNRTI/1K PI/30K NNRTI/30K
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/66 (0.00%)      0/68 (0.00%)      0/65 (0.00%)      0/64 (0.00%)    
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.
Results Point of Contact
Name/Title: Melissa Allen, Director, IMPAACT Operations Center
Organization: Family Health International (FHI 360)
Phone: (919) 405-1429
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00039741     History of Changes
Other Study ID Numbers: P390
PENPACT-1B
10106 ( Registry Identifier: DAIDS ES )
PENTA 9/PACTG 390
First Submitted: June 7, 2002
First Posted: June 11, 2002
Results First Submitted: December 19, 2011
Results First Posted: April 24, 2012
Last Update Posted: February 7, 2019