Trial · NCT00084136
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 18 of 18
Download this page as JSON| 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). |
| Secondary | Time to Immunologic Failure (NRTI Comparison) | At or after Week 48 (including all follow-up through study closure - May 31,2010) | 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 (NRTI Comparison) | weeks 24, 48 and 96 (including all follow-up through to study closure on May 31, 2010) | 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 | Plasma HIV-1 Viral Load Fewer Than 400 Copies/ml (NRTI Comparison) | At Weeks 24 and 48 (including follow-up through to study closure on May 31, 2010) | 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 at Week 48 (Defined by FDA TLOVR Algorithm - Excluding Study Allowed ARV Substitutions)(NRTI Comparison) | Week 48 (using follow-up through study closure on May 31,2010) | 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 96 (Defined by FDA TLOVR Algorithm - Excluding Study Allowed ARV Substitutions)(NRTI Comparison) | Week 96 (using follow-up through to study closure on May 31,2010) | Time from randomization to any of the following events occurring prior to week 96: 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)(NRTI Comparison) | Week 48 using follow-up through study closure on May 31,2010 | 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 Loss of Virologic Response at Week 96 (Defined by FDA TLOVR Algorithm - Including All ARV Substitutions)(NRTI Comparison) | Week 96 using follow-up through study closure on May 31,2010 | Time to any of the following events occurring prior to week 96: 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 First Dose Modification or Grade 3 or 4 Adverse Event (NRTI Comparison) | Throughout study follow-up until study closure (May 31, 2010) | 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. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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.
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