Trial · NCT00039741
Anti-HIV Drug Regimens and Treatment-Switching Guidelines in HIV Infected Children
NCT00039741, Phase 2, Phase 3, Completed, National Institute of Allergy and Infectious Diseases (NIAID); results first posted 2012-04-24
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ConductScience Library. Anti-HIV Drug Regimens and Treatment-Switching Guidelines in HIV Infected Children. Trials, record NCT00039741. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00039741
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Anti-HIV Drug Regimens and Treatment-Switching Guidelines in HIV Infected Children
- NCT number
- NCT00039741
- Status
- Completed
- Phases
- Phase 2, Phase 3
- Enrollment
- 266 participants, actual
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
- Conditions
- HIV Infections
- Interventions
- NRTIs (ABC, FTC, FTC/TDF, 3TC, 3TC/AZT, d4T, TDF, ddC, AZT), NNRTIs (EFV, NVP), PIs (AMP, IDV, LPV/r, NFV, SQV, RTV)
- First posted
- 2002-06-11
- Last updated
- 2021-11-05
- Results first posted
- 2012-04-24
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Viral Load Measured in log10 HIV-1 RNA Copies/ml | Baseline visit and 4 years after Study Entry | |
| Secondary | Rate of Grade 3 or Higher Signs, Symptoms, or Laboratory Abnormalities Experienced | Up to 6 yrs. (average 4.85 yrs.) | 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. |
| Secondary | Participants With Significant HIV-related Clinical Events, Defined as CDC Category C (AIDS Defining) Diagnoses (Except for Recurrent Bacterial Infections)or Death | Up to 6 yrs. (average 4.85 yrs.) | |
| Secondary | Time to Switching to an Alternative Class ART Regimen (Based on Initial Randomized Regimen) | Up to 6 yrs. (average 4.85 yrs.) | 25th Percentiles in weeks from randomization to starting an alternative class ART regimen (based on initial randomized regimen) |
| Secondary | Time to HIV-1 RNA of 400 Copies/ml or Greater During First-line Therapy or Permanent Discontinuation of First-line Therapy | Up to 6 yrs. (average 4.85 yrs.) | 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. |
| Secondary | Time to HIV-1 RNA of 30,000 Copies/ml or Greater During Second-line Therapy or Permanent Discontinuation of Second-line Therapy | Up to 6 yrs. (average 4.85 yrs.) | 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 |
| Secondary | Number of Children With an HIV-1 RNA Level Less Than 400 Copies/ml Regardless of Therapy at Week 204 | Week 204 | |
| Secondary | Change in CD4% From Randomization to 4 Years | Randomization to 4 years | |
| Secondary | Number of Children With HIV-1 RNA Less Than 400 Copies/ml and on Original Randomized Therapy at 24 Weeks | 24 weeks |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Viral Load Measured in log10 HIV-1 RNA Copies/ml | Baseline visit and 4 years after Study Entry | 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). | log10 HIV-1 RNA | MEAN |
| SECONDARY | Rate of Grade 3 or Higher Signs, Symptoms, or Laboratory Abnormalities Experienced | Up to 6 yrs. (average 4.85 yrs.) | Intent to treat | events/100 child-years | MEAN |
| SECONDARY | Participants With Significant HIV-related Clinical Events, Defined as CDC Category C (AIDS Defining) Diagnoses (Except for Recurrent Bacterial Infections)or Death | Up to 6 yrs. (average 4.85 yrs.) | Intent to treat | participants | NUMBER |
| SECONDARY | Time to Switching to an Alternative Class ART Regimen (Based on Initial Randomized Regimen) | Up to 6 yrs. (average 4.85 yrs.) | Intent to treat | Weeks (25th Percentile) | MEDIAN |
| SECONDARY | Time to HIV-1 RNA of 400 Copies/ml or Greater During First-line Therapy or Permanent Discontinuation of First-line Therapy | Up to 6 yrs. (average 4.85 yrs.) | Intent to treat | Weeks (25th Percentile) | NUMBER |
| SECONDARY | Time to HIV-1 RNA of 30,000 Copies/ml or Greater During Second-line Therapy or Permanent Discontinuation of Second-line Therapy | Up to 6 yrs. (average 4.85 yrs.) | Intent to treat | Weeks (25th Percentile) | NUMBER |
| SECONDARY | Number of Children With an HIV-1 RNA Level Less Than 400 Copies/ml Regardless of Therapy at Week 204 | Week 204 | Intent to treat. Numbers are reported among participants who had an HIV-1 RNA value and were in follow-up at week 204. | participants | NUMBER |
| SECONDARY | Change in CD4% From Randomization to 4 Years | Randomization to 4 years | Intent to treat, for participants who had CD4% values available at 4 years and at baseline. | CD4 percent (% of total lymphocytes) | MEAN |
| SECONDARY | Number of Children With HIV-1 RNA Less Than 400 Copies/ml and on Original Randomized Therapy at 24 Weeks | 24 weeks | Intent to treat - numbers are reported among participants who had an HIV-1 RNA value and were in follow-up at week 24. | participants | NUMBER |
Source ClinicalTrials.gov
Results by group36
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Viral Load Measured in log10 HIV-1 RNA Copies/ml | Drug Class/PI | -3.16 | Standard Error 0.09 | log10 HIV-1 RNA | |
| Change in Viral Load Measured in log10 HIV-1 RNA Copies/ml | Drug Class/NNRTI | -3.31 | Standard Error 0.09 | log10 HIV-1 RNA | |
| Change in Viral Load Measured in log10 HIV-1 RNA Copies/ml | Switch Point (1K) | -3.26 | Standard Error 0.09 | log10 HIV-1 RNA | |
| Change in Viral Load Measured in log10 HIV-1 RNA Copies/ml | Switch Point (30K) | -3.20 | Standard Error 0.09 | log10 HIV-1 RNA | |
| Rate of Grade 3 or Higher Signs, Symptoms, or Laboratory Abnormalities Experienced | Drug Class/PI | 0.16 | 95% Confidence Interval 0.08 to 0.31 | events/100 child-years | |
| Rate of Grade 3 or Higher Signs, Symptoms, or Laboratory Abnormalities Experienced | Drug Class/NNRTI | 0.17 | 95% Confidence Interval 0.09 to 0.31 | events/100 child-years | |
| Rate of Grade 3 or Higher Signs, Symptoms, or Laboratory Abnormalities Experienced | Switch Point (1K) | 0.16 | 95% Confidence Interval 0.08 to 0.31 | events/100 child-years | |
| Rate of Grade 3 or Higher Signs, Symptoms, or Laboratory Abnormalities Experienced | Switch Point (30K) | 0.17 | 95% Confidence Interval 0.09 to 0.31 | events/100 child-years | |
| Participants With Significant HIV-related Clinical Events, Defined as CDC Category C (AIDS Defining) Diagnoses (Except for Recurrent Bacterial Infections)or Death | Drug Class/PI | 6 | participants | ||
| Participants With Significant HIV-related Clinical Events, Defined as CDC Category C (AIDS Defining) Diagnoses (Except for Recurrent Bacterial Infections)or Death | Drug Class/NNRTI | 4 | participants |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 results by groupParticipant flow16
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | PI/1K | 66 | |
| Overall Study | STARTED | NNRTI/1K | 68 | |
| Overall Study | STARTED | PI/30K | 65 | |
| Overall Study | STARTED | NNRTI/30K | 64 | |
| Overall Study | Death | PI/1K | 0 | |
| Overall Study | Death | NNRTI/1K | 1 | |
| Overall Study | Death | PI/30K | 0 | |
| Overall Study | Death | NNRTI/30K | 0 | |
| Overall Study | COMPLETED | PI/1K | 51 | |
| Overall Study | COMPLETED | NNRTI/1K | 56 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 participant flowAdverse events260
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| serious | Anemia | Blood and lymphatic system disorders | PI/1K | 1 | 66 | 1 |
| serious | Anemia | Blood and lymphatic system disorders | NNRTI/1K | 0 | 68 | 0 |
| serious | Anemia | Blood and lymphatic system disorders | PI/30K | 0 | 65 | 0 |
| serious | Anemia | Blood and lymphatic system disorders | NNRTI/30K | 1 | 64 | 1 |
| serious | Anemia megaloblastic | Blood and lymphatic system disorders | PI/1K | 0 | 66 | 0 |
| serious | Anemia megaloblastic | Blood and lymphatic system disorders | NNRTI/1K | 0 | 68 | 0 |
| serious | Anemia megaloblastic | Blood and lymphatic system disorders | PI/30K | 1 | 65 | 1 |
| serious | Anemia megaloblastic | Blood and lymphatic system disorders | NNRTI/30K | 0 | 64 | 0 |
| serious | Aplastic anemia | Blood and lymphatic system disorders | PI/1K | 0 | 66 | 0 |
| serious | Aplastic anemia | Blood and lymphatic system disorders | NNRTI/1K | 0 | 68 | 0 |
1 to 10 of 260Source ClinicalTrials.gov
See all 260 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | PI/1K | ||
| Total, all-cause mortality | NNRTI/1K | ||
| Total, all-cause mortality | PI/30K | ||
| Total, all-cause mortality | NNRTI/30K | ||
| Total, other adverse events | PI/1K | 0 | 66 |
| Total, other adverse events | NNRTI/1K | 0 | 68 |
| Total, other adverse events | PI/30K | 0 | 65 |
| Total, other adverse events | NNRTI/30K | 0 | 64 |
| Total, serious adverse events | PI/1K | 9 | 66 |
| Total, serious adverse events | NNRTI/1K | 10 | 68 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers5
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00039741
GET https://conductscience.org/api/trials/v1/NCT00039741/results?page=2