Trial · NCT00524368
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| 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 | The TLOVR algorithm was used to derive response, ie, response and loss of response needed to be confirmed at 2 consecutive visits and participants who permanently discontinued were considered nonresponders after discontinuation. Participants with intermittent missing viral load values were considered responders if the preceeding and succeeding visits indicated response. In all other cases, intermittent values were imputed with nonresponse. Resuppression after confirmed virologic failure was considered as failure in this algorithm. |
| Secondary | Virologic Response at Week 48 (Viral Load Less Than 400 Copies/mL) | 48 weeks | Number of participants with confirmed plasma viral load less than 400 copies/mL at Week 48. |
| Secondary | Change in log10 Viral Load From Baseline at Week 48 | 48 weeks | |
| Secondary | Time to Reach First Virologic Response | 48 weeks | Time (in weeks) to achieve viral load less than 50 copies/mL by the participants. |
| Secondary | Time to Loss of Virologic Response | 48 weeks | Time taken to lose the virologic response ie, plasma viral load less than 50 copies/mL by participants. |
| Secondary | Time-averaged Difference (DAVG) of log10 Plasma Viral Load Over 48 Weeks | 48 weeks | |
| Secondary | Change in CD4+ Cell Count From Baseline | 48 Weeks | CD4+ cell count was calculated using the Last Observation Carried Forward (LOCF) algorithm. |
| Secondary | Change From Baseline in Total Functional Assessment of HIV Infection (FAHI) Score | 48 weeks | The FAHI is a 44-item questionnaire and incorporates 5 functional scales (physical well-being, emotional well-being/living with HIV, functional and global well-being, social well-being, and cognitive functioning). Each scale included several questions (all 5 scales include total 44 questions). For each question, participants gave a score of either 0 (not at all), 1 (a little bit), 2 (somewhat), 3 (quite a bit) and 4 (very much). Total FAHI imputed score is calculated by adding scores for each question. The range of total FAHI score is 0 to 176. Higher scores indicate worsening. |
| 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 | Self-reported adherence to the ARV medications was measured. The M-MASRI asks participants to report the number of doses taken, as well as the number of doses taken during the last 30 days prior to the study visit by means of a horizontal visual analogue scale (VAS) that generates a self-rated percentage of doses of all the ARV medications taken during the past 30 days. |
| 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. | Pharmacokinetic parameter AUC24h was assessed from the time of study medication administration upto 24 hour postdose. Population Pharmacokinetic Estimates of DRV and rtv were evaluated. |
| 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 | Pharmacokinetic parameter C0h was assessed. Population Pharmacokinetic Estimates of DRV and rtv were evaluated. |
| Secondary | Number of Participants Developing Mutations at Endpoint | 48 weeks | Development of Mutations in Virologic Failures (Plasma Viral Load less than 50 Copies/mL) at endpoint. |
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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