Trial · NCT00084136
Prospective Evaluation of Anti-retroviral Combinations for Treatment Naive, HIV Infected Persons in Resource-limited Settings
NCT00084136, Phase 4, Completed, Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections; results first posted 2011-08-09
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Prospective Evaluation of Anti-retroviral Combinations for Treatment Naive, HIV Infected Persons in Resource-limited Settings. Trials, record NCT00084136. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00084136
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Prospective Evaluation of Anti-retroviral Combinations for Treatment Naive, HIV Infected Persons in Resource-limited Settings
- NCT number
- NCT00084136
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 1,571 participants, actual
- Lead sponsor
- Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
- Conditions
- HIV Infections
- Interventions
- Atazanavir, Didanosine (enteric-coated), Efavirenz, Emtricitabine, Emtricitabine/Tenofovir disoproxil fumarate, Lamivudine/Zidovudine
- First posted
- 2004-06-08
- Last updated
- 2018-10-10
- Results first posted
- 2011-08-09
Source ClinicalTrials.gov
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Time to Treatment Failure (PI Comparison) | Virologic failure starting 14 weeks following randomization; disease progression starting 12 weeks following randomization; and death occurring at any time following randomization. Follow-up until ddI+FTC+ATV arm closed (May 22, 2008). | Time from randomization to the earliest of: scheduled week of first plasma sample meeting virologic failure (two consecutive plasma HIV-1 RNA values 1,000 copies/mL or higher, regardless of whether ARV medications being taken at the time); scheduled week of first AIDS defining diagnosis (WHO Stage 4 (2005), plus microsporidiosis, cyclospora gastroenteritis and Chaga's disease), not attributed to Immune Reconstitution Inflammatory Syndrome (reviewed by chairs); date of death (due to any cause). Plasma drawn every 8 weeks (except confirmation samples could be drawn earlier). |
| Primary | Time to Treatment Failure (NRTI Comparison) | Virologic failure starting 14 weeks following randomization; disease progression starting 12 weeks following randomization; and death occurring at any time following randomization. Follow-up through study closure (May 31, 2010). | Time from randomization to the earliest of: scheduled week of first plasma sample meeting virologic failure (two consecutive plasma HIV-1 RNA values 1,000 copies/mL or higher, regardless of whether ARV medications being taken at the time); scheduled week of first AIDS defining diagnosis (WHO Stage 4 (2005) plus microsporidiosis, cyclospora gastroenteritis and Chaga's disease), not attributed to Immune Reconstitution Inflammatory Syndrome (reviewed by chairs); date of death (due to any cause). Plasma drawn every 8 weeks (except confirmation samples could be drawn earlier). |
| Secondary | Time to Discontinuation of Initial Antiretroviral (ARV) Therapy (PI Comparison) | Throughout follow-up until ddI+FTC+ATV arm closed (May 22,2008) | Time is measured from date of treatment initiation to earliest of the following: date of last participant contact (premature discontinuation of study follow-up); date all ARV medications were held (if all medications held for at least 8 weeks, for any reason); date that any ARV medication was changed (excluding the following single ARV substitutions: stavudine or tenofovir for zidovudine, nevirapine for efavirenz, or didanosine for tenofovir). |
| Secondary | Time to Immunologic Failure (PI Comparison) | At or after Week 48 (including only follow-up until ddI+FTV+ATV arm closed - May 22,2008) | Time from randomization to the first scheduled study visit (week 48 or later) with a CD4+ cell count fewer than 100 cells/mm3. |
| Secondary | Change in CD4 Count From Screening to Weeks 24, 48, 96 (PI Comparison) | weeks 24, 48 and 96 (including follow-up until ddI+FTC+ARV arm closed - May 22, 2008) | Available pre-randomization CD4 cell counts were limited to the single CD4 cell count used for study eligibility (and therefore must have been fewer than 300 cells/mm3). |
| Secondary | Time to First Dose Modification or Grade 3 or 4 Adverse Event (PI Comparison) | Throughout study follow-up until ddI+FTC+ATV arm closed (May 22, 2008) | Time from treatment dispensation to the first occurring of the following: week of first ARV medication change; week of first grade 3 or higher sign/symptom or laboratory abnormality (total bilirubin was excluded) that was at least one grade higher than baseline. Grading used the Division of AIDS (DAIDS) 2004 Severity of Adverse Events Tables. |
| Secondary | Plasma HIV-1 Viral Load Fewer Than 400 Copies/ml (PI Comparison) | At Weeks 24 and 48 (including only follow-up until ddI+FTC+ARV arm closed - May 22, 2008) | Number of participants with plasma HIV-1 Viral load fewer than 400 copies/mL at study visit weeks 24 and 48. Closest observed result between 20 and up to 28 weeks (for week 24), and between 44 and up to 52 (for week 48) used if multiple results available. Missing values excluded, and both study treatment status and history ignored. |
| Secondary | Time to Loss of Virologic Response by Week 48 (Defined by FDA TLOVR Algorithm - Excluding Study Allowed ARV Substitutions)(PI Comparison) | Week 48 (using follow-up only until closing of ddI+FTV+ATV arm on May 22,2008) | Time from randomization to any of the following events occurring prior to week 48: discontinued ARV regimen (see time to discontinuation of initial ARV therapy above); discontinued study follow-up or died; absence of virologic suppression defined as 2 consecutive plasma HIV-1 RNA values \< 400 copies/mL; two consecutive plasma HIV-1 RNA values \> 400 copies/mL following virologic suppression. |
| Secondary | Time to Loss of Virologic Response at Week 48 (Defined by FDA TLOVR Algorithm - Including All ARV Substitutions)(PI Comparison) | Week 48 (using follow-up only until closing of ddI+FTV+ATV arm on May 22,2008) | Time from randomization to any of the following events occurring prior to week 48: changed any ARV medication (including permanent discontinuation of all medications); discontinued study follow-up or died; absence of virologic suppression defined as 2 consecutive plasma HIV-1 RNA values \< 400 copies/mL; two consecutive plasma HIV-1 RNA values \> 400 copies/mL following virologic suppression. |
| Secondary | Time to Discontinuation of Initial Antiretroviral (ARV) Therapy (NRTI Comparison) | Throughout follow-up until study closed (May 31,2010) | Time is measured from date of treatment initiation to earliest of the following: date of last participant contact (premature discontinuation of study follow-up); date all ARV medications were held (if all medications held for at least 8 weeks, for any reason); date that any ARV medication was changed (excluding the following single ARV substitutions: stavudine or tenofovir for zidovudine, nevirapine for efavirenz, or didanosine for tenofovir). |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 registered outcomesOutcomes18
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Time to Treatment Failure (PI Comparison) | Virologic failure starting 14 weeks following randomization; disease progression starting 12 weeks following randomization; and death occurring at any time following randomization. Follow-up until ddI+FTC+ATV arm closed (May 22, 2008). | ITT (study treatment status and history ignored); censoring time was latest study visit week where plasma HIV-1 RNA was measured. | weeks | NUMBER |
| PRIMARY | Time to Treatment Failure (NRTI Comparison) | Virologic failure starting 14 weeks following randomization; disease progression starting 12 weeks following randomization; and death occurring at any time following randomization. Follow-up through study closure (May 31, 2010). | ITT (study treatment status and history ignored); censoring time was latest study visit week where plasma HIV-1 RNA was measured. | weeks | NUMBER |
| SECONDARY | Time to Discontinuation of Initial Antiretroviral (ARV) Therapy (PI Comparison) | Throughout follow-up until ddI+FTC+ATV arm closed (May 22,2008) | Participants not starting study treatment excluded. | weeks | NUMBER |
| SECONDARY | Time to Immunologic Failure (PI Comparison) | At or after Week 48 (including only follow-up until ddI+FTV+ATV arm closed - May 22,2008) | ITT (ignoring current study treatment status or history) | weeks | NUMBER |
| SECONDARY | Change in CD4 Count From Screening to Weeks 24, 48, 96 (PI Comparison) | weeks 24, 48 and 96 (including follow-up until ddI+FTC+ARV arm closed - May 22, 2008) | ITT - ignoring both current treatment status and treatment history. | cells/mm^3 | MEDIAN |
| SECONDARY | Time to First Dose Modification or Grade 3 or 4 Adverse Event (PI Comparison) | Throughout study follow-up until ddI+FTC+ATV arm closed (May 22, 2008) | Participants never starting meds excluded. Censoring time is scheduled study week of last clinic visit. | weeks | NUMBER |
| SECONDARY | Plasma HIV-1 Viral Load Fewer Than 400 Copies/ml (PI Comparison) | At Weeks 24 and 48 (including only follow-up until ddI+FTC+ARV arm closed - May 22, 2008) | ITT (ignoring current treatment status or past treatment history); closest value to week 24 (48) used if multiple values available; missing values ignored. | participants | NUMBER |
| SECONDARY | Time to Loss of Virologic Response by Week 48 (Defined by FDA TLOVR Algorithm - Excluding Study Allowed ARV Substitutions)(PI Comparison) | Week 48 (using follow-up only until closing of ddI+FTV+ATV arm on May 22,2008) | Substitutions not triggering TLOVR event included the following: stavudine or tenofovir-DF for zidovudine; nevirapine for efavirenz; or didanosine for tenofovir-DF. | weeks | NUMBER |
| SECONDARY | Time to Loss of Virologic Response at Week 48 (Defined by FDA TLOVR Algorithm - Including All ARV Substitutions)(PI Comparison) | Week 48 (using follow-up only until closing of ddI+FTV+ATV arm on May 22,2008) | weeks | NUMBER | |
| SECONDARY | Time to Discontinuation of Initial Antiretroviral (ARV) Therapy (NRTI Comparison) | Throughout follow-up until study closed (May 31,2010) | Participants not starting study treatment excluded. | weeks | NUMBER |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 outcomesResults by group100
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Time to Treatment Failure (PI Comparison) | ZDV/3TC+EFV | 5th percentile | 16 | 95% Confidence Interval 16 to 24 | weeks |
| Time to Treatment Failure (PI Comparison) | ddI+FTC+ATV | 5th percentile | 16 | 95% Confidence Interval 16 to 16 | weeks |
| Time to Treatment Failure (PI Comparison) | ZDV/3TC+EFV | 10th percentile | 40 | 95% Confidence Interval 24 to 64 | weeks |
| Time to Treatment Failure (PI Comparison) | ddI+FTC+ATV | 10th percentile | 24 | 95% Confidence Interval 16 to 32 | weeks |
| Time to Treatment Failure (PI Comparison) | ZDV/3TC+EFV | 25th percentile | NA | 95% Confidence Interval 152 to NA | weeks |
| Time to Treatment Failure (PI Comparison) | ddI+FTC+ATV | 25th percentile | 120 | 95% Confidence Interval 96 to NA | weeks |
| Time to Treatment Failure (NRTI Comparison) | ZDV/3TC+EFV | 5th percentile | 16 | 95% Confidence Interval 16 to 24 | weeks |
| Time to Treatment Failure (NRTI Comparison) | TDF/FTC+EFV | 5th percentile | 16 | 95% Confidence Interval 16 to 24 | weeks |
| Time to Treatment Failure (NRTI Comparison) | ZDV/3TC+EFV | 10th percentile | 40 | 95% Confidence Interval 24 to 71 | weeks |
| Time to Treatment Failure (NRTI Comparison) | TDF/FTC+EFV | 10th percentile | 40 | 95% Confidence Interval 24 to 64 | weeks |
1 to 10 of 100Source ClinicalTrials.gov
See all 100 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| PI Comparison | STARTED | ZDV/3TC+EFV | 519 | |
| PI Comparison | STARTED | ddI+FTC+ATV | 526 | |
| PI Comparison | STARTED | TDF/FTC+EFV | 0 | |
| PI Comparison | COMPLETED | ZDV/3TC+EFV | 464 | |
| PI Comparison | COMPLETED | ddI+FTC+ATV | 479 | |
| PI Comparison | COMPLETED | TDF/FTC+EFV | 0 | |
| PI Comparison | NOT COMPLETED | ZDV/3TC+EFV | 55 | |
| PI Comparison | NOT COMPLETED | ddI+FTC+ATV | 47 | |
| PI Comparison | NOT COMPLETED | TDF/FTC+EFV | 0 | |
| NRTI Comparison | STARTED | ZDV/3TC+EFV | 519 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events513
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 |
|---|---|---|---|---|---|---|
| other | Lymphadenopathy | Blood and lymphatic system disorders | ZDV/3TC+EFV | 27 | 519 | |
| other | Lymphadenopathy | Blood and lymphatic system disorders | ddI+FTC+ATV | 24 | 526 | |
| other | Lymphadenopathy | Blood and lymphatic system disorders | TDF/FTC+EFV | 30 | 526 | |
| other | Ocular icterus | Eye disorders | ZDV/3TC+EFV | 7 | 519 | |
| other | Ocular icterus | Eye disorders | ddI+FTC+ATV | 49 | 526 | |
| other | Ocular icterus | Eye disorders | TDF/FTC+EFV | 12 | 526 | |
| other | Abdominal pain | Gastrointestinal disorders | ZDV/3TC+EFV | 39 | 519 | |
| other | Abdominal pain | Gastrointestinal disorders | ddI+FTC+ATV | 57 | 526 | |
| other | Abdominal pain | Gastrointestinal disorders | TDF/FTC+EFV | 52 | 526 | |
| other | Diarrhoea | Gastrointestinal disorders | ZDV/3TC+EFV | 43 | 519 |
1 to 10 of 513Source ClinicalTrials.gov
See all 513 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | ZDV/3TC+EFV | ||
| Total, all-cause mortality | ddI+FTC+ATV | ||
| Total, all-cause mortality | TDF/FTC+EFV | ||
| Total, other adverse events | ZDV/3TC+EFV | 481 | 519 |
| Total, other adverse events | ddI+FTC+ATV | 521 | 526 |
| Total, other adverse events | TDF/FTC+EFV | 489 | 526 |
| Total, serious adverse events | ZDV/3TC+EFV | 86 | 519 |
| Total, serious adverse events | ddI+FTC+ATV | 84 | 526 |
| Total, serious adverse events | TDF/FTC+EFV | 55 | 526 |
Source ClinicalTrials.gov
Papers11
The papers the trial lists on ClinicalTrials.gov.
Grants2
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|---|---|---|---|---|---|
| K24AI051966 | Antiretroviral Therapy for HIV-Infected Patients | GULICK, ROY M. | WEILL MEDICAL COLL OF CORNELL UNIV | NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES | 2003 to 2012 | NIH RePORTER |
| U01AI068636 | AIDS Clinical Trials Group Network | KURITZKES, DANIEL R. | SOCIAL AND SCIENTIFIC SYSTEMS, INC. | NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES | 2006 to 2010 | NIH RePORTER |
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/NCT00084136
GET https://conductscience.org/api/trials/v1/NCT00084136/results?page=2