Trial · NCT00524368
Outcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Virological Response at Week 48 (Number of Participants With Plasma Viral Load Less Than 50 Copies/mL) - as Defined by the Time to Loss of Virologic Response (TLOVR) Algorithm | 48 Weeks | Intention To Treat (ITT) population: Participants who permanently discontinued were considered nonresponders after discontinuation. Participants with intermittent missing viral load values were considered responders if preceeding and succeeding visits indicated response. Otherwise, intermittent values were imputed with nonresponse. | Participants | NUMBER |
| SECONDARY | Virologic Response at Week 48 (Viral Load Less Than 400 Copies/mL) | 48 weeks | Intention To Treat (ITT) population: Participants who permanently discontinued were considered nonresponders after discontinuation. Participants with intermittent missing viral load values were considered responders if preceeding and succeeding visits indicated response. Otherwise, intermittent values were imputed with nonresponse. | Participants | NUMBER |
| SECONDARY | Change in log10 Viral Load From Baseline at Week 48 | 48 weeks | Intention To Treat (ITT) population: Participants who permanently discontinued were considered nonresponders after discontinuation. Participants with intermittent missing viral load values were considered responders if preceeding and succeeding visits indicated response. Otherwise, intermittent values were imputed with nonresponse. | log10 copies/mL | MEDIAN |
| SECONDARY | Time to Reach First Virologic Response | 48 weeks | Intention To Treat (ITT) population: Participants who permanently discontinued were considered nonresponders after discontinuation. Participants with intermittent missing viral load values were considered responders if preceeding and succeeding visits indicated response. Otherwise, intermittent values were imputed with nonresponse. | Days | MEDIAN |
| SECONDARY | Time to Loss of Virologic Response | 48 weeks | Intention To Treat (ITT) population: Participants who permanently discontinued were considered nonresponders after discontinuation. Participants with intermittent missing viral load values were considered responders if preceeding and succeeding visits indicated response. Otherwise, intermittent values were imputed with nonresponse. | Days | MEAN |
| SECONDARY | Time-averaged Difference (DAVG) of log10 Plasma Viral Load Over 48 Weeks | 48 weeks | Intention To Treat (ITT) population: Observed cases | log10 copies/mL | LEAST_SQUARES_MEAN |
| SECONDARY | Change in CD4+ Cell Count From Baseline | 48 Weeks | Intention To Treat (ITT) population - last observation carried forward (LOCF): Intermittent missing values and missing values due to premature discontinuation were imputed with the last observation. | 10e6/l | MEDIAN |
| SECONDARY | Change From Baseline in Total Functional Assessment of HIV Infection (FAHI) Score | 48 weeks | Intention To Treat (ITT) population - last observation carried forward (LOCF): Intermittent missing values and missing values due to premature discontinuation were imputed with the last observation. | Scores on a scale | MEDIAN |
| SECONDARY | Percentage of Participants Adherent/Non-adherent to ARV as Determined by Modified Medication Adherence Self Report Inventory (M-MASRI) Questionnaire at Week 48 | 48 weeks | Intent-to-Treat (ITT) population: Participants who were randomized and who received at least 1 dose of study medication. | Percentage of participants | NUMBER |
| SECONDARY | Area Under the Curve From the Time of Study Medication Administration Upto 24 Hour Postdose (AUC24h) of DRV and Rtv | 0 hour predose and 1 hour post dose measured at Weeks 4 and 24. Any time point measured at Weeks 8 and 48. | Intent-to-Treat (ITT) population: Participants who were randomized and who received at least 1 dose of study medication. | ng*h/mL | MEDIAN |
| SECONDARY | Predose Plasma Concentration (C0h) of DRV and Rtv. | 0 hour predose and 1 hour post dose measured at Weeks 4 and 24. Any time point measured at Weeks 8 and 48 | Intent-to-Treat (ITT) population: Participants who were randomized and who received at least 1 dose of study medication. | ng/mL | MEDIAN |
| SECONDARY | Number of Participants Developing Mutations at Endpoint | 48 weeks | Intent-to-Treat (ITT) population: Participants who were randomized and who received at least 1 dose of study medication. | Participants | NUMBER |
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.
For software
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT00524368/outcomes