Trial · NCT00561925
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Comparison of Proportion of Virologic Response at Week 48 Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population | week 48 | Primary endpoint was the number of patients with a sustained virologic response through week 48 using LLOQ = 50 copies/mL |
| Secondary | Kaplan-Meier Estimates of the Proportions of Patients Without Loss of Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population | week 0 to 144 | |
| Secondary | Proportion of Sustained Virologic Response at Week 144 Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population | week 144 | Endpoint was the number of patients with a sustained virologic response through week 144 using LLOQ = 50 copies/mL |
| Secondary | Kaplan-Meier Estimates for Time to New AIDS or AIDS-related Progression Event or Death, Full Analysis Set Population | week 0 to 144 | |
| Secondary | Comparison of HIV-1 Viral Load (log10 Copies/mL) Change From Baseline at Week 144, Full Analysis Set Population | baseline, week 144 | |
| Secondary | Comparison of CD4+ Cell Count (Cells/Cubic Millimeter) Change From Baseline at Week 144, Full Analysis Set Population | baseline, week 144 | |
| Secondary | Occurrence of Rashes | until last patient completed 144 weeks (up to 193 weeks) | Frequency of patients with drug related rash events by functional grouping |
| Secondary | Occurrence of Elevations in Laboratory Measurement by DAIDS Grade | until last patient completed 144 weeks (up to 193 weeks) | |
| Secondary | Kaplan -Meier Estimate of Cumulative Probability of Permanent Discontinuation of Study Medication | week 0 to 144 | |
| Secondary | Kaplan -Meier Estimate of Cumulative Probability of Grade 3 or 4 ALT/AST Abnormalities | week 0 to 72 | |
| Secondary | Kaplan -Meier Estimate of Cumulative Probability of Grade 3 or 4 Asymptotic Transaminases Abnormalities | week 0 to 72 | |
| Secondary | Kaplan -Meier Estimate of Cumulative Probability of Clinical Hepatic Events | week 0 to 72 | |
| Secondary | Kaplan -Meier Estimate of Cumulative Probability of Group III or IV Drug-related Rash | week 0 to 72 | |
| Secondary | Relative Bioavailability Trough C_pre,ss,1 | week 132 | Relative bioavailability measured of trough concentrations. Analysis based on adjusted by-treatment geometric means, the adjusted geometric mean ratio of NVP XR : NVP IR and it's 90% confidence interval with p-value and the inter-individual geometric coefficient of variation. |
| Secondary | Occurrence of Hepatic Events | until last patient completed 144 weeks (up to 193 weeks) | Frequency of patients with hepatitis symptoms |
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/NCT00561925/registered