Trial · NCT00855413
Registered outcomes38
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
21 to 38 of 38
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Secondary | Minimum Ritonavir Exposure in Semen Among Participants Who Consented to an Optional Collection of Semen | Weeks 0-4 and Weeks 12, 48 | |
| Secondary | Maximum Etravirine Exposure in Ileal Tissue Among Participants Who Consented to an Optional Gut Biopsy Procedure | between Week 4-12 and between Weeks 36-48 | |
| Secondary | Minimum Etravirine Exposure Range in Ileal Tissue Among Participants Who Consented to an Optional Gut Biopsy Procedure | between Week 4-12 and between Weeks 36-48 | |
| Secondary | Maximum Darunavir Exposure Range in Ileal Tissue Among Participants Who Consented to an Optional Gut Biopsy Procedure | between Week 4-12 and between Weeks 36-48 | |
| Secondary | Minimum Darunavir Exposure Range in Ileal Tissue Among Participants Who Consented to an Optional Gut Biopsy Procedure | between week 4-12 and between weeks 36-48 | |
| Secondary | Maximum Ritonavir Exposure Range in Ileal Tissue Among Participants Who Consented to an Optional Gut Biopsy Procedure | between week 4-12 and between Weeks 36-48 | |
| Secondary | Minimum Ritonavir Exposure Range in Ileal Tissue Among Participants Who Consented to an Optional Gut Biopsy Procedure | between week 4-12 and between weeks 36-48 | |
| Secondary | Number of Participants With HIV RNA Measurement Above the Limits of Detection in Cerebrospinal Fluid | Week 4 and Week 48 | |
| Secondary | Number of Participants With Neurocognitive Impairment at Baseline | Week 2 or 4 | |
| Secondary | Number of Participants With Neurocognitive Impairment at Week 24 | Week 24 | |
| Secondary | Number of Participants With Neurocognitive Impairment at Week 48 | Week 48 | |
| Secondary | Overall Neurocognitive Impairment Score at Week 2 or 4 | Week 2 or 4 | Neuropsychological performance was assessed at Week 2 or 4, Week 24 and Week 48 in the following measures: Premorbid/language (Wide Range Achievement Test 4 -Reading Subtest), Learning (HVLT-R, Hopkins Verbal Learning Test-Revised), Memory (HVLT-R), Speed of Processing (Trailmaking A (Army Individual Test Battery, 1944), 1974, Stroop color, Attention (WAIS-III Symbol Search; Stroop word, Fine motor, Executive (Trailmaking B, Stroop interference, Letter, Category Fluency. An overall summary score was created by averaging all tests. Participants also completed the self-reported functional status Patient's Assessment of Own Functioning Inventory (PAOFI) and the Activities of Daily Living Scale (ADLS). Best available demographically corrected normative data were utilized to create z scores. A negative z score denotes below-average performance relative to a US normative comparison population. A higher z score is a better outcome. |
| Secondary | Overall Neurocognitive Impairment at Week 24 | Week 24 | Neuropsychological performance was assessed at week 2 or 4, week 24 and week 48 in the following measures: Premorbid/language (Wide Range Achievement Test 4 -Reading Subtest), Learning (Hopkins Verbal Learning Test - Revised), Memory (HVLT-R), Speed of Processing (Trailmaking A (Army Individual Test Battery, 1944), 1974, Stroop color, Attention (WAIS-III Symbol Search; Stroop word, Fine motor, Executive (Trailmaking B, Stroop interference, Letter, Category Fluency. An overall summary score of neurocognitive functioning was created by averaging all tests. Participants also completed Patient's Assessment of Own Functioning Inventory (PAOFI) and the Activities of Daily Living Scale (ADLS). Best available demographically corrected normative data were utilized to create z scores. A negative z score denotes below-average performance relative to a US normative comparison population. A higher z score is a better outcome. |
| Secondary | Overall Neurocognitive Impairment at Week 48 | Week 48 | Neuropsychological performance was assessed at baseline (week 2 or 4), week 24 and week 48 in the following domain (measures): Premorbid/language (Wide Range Achievement Test (WRAT) 4 - Reading Subtest), Learning (HVLT-R, Hopkins Verbal Learning Test - Revised), Memory (HVLT-R), Speed of Processing (Trailmaking A (Army Individual Test Battery, 1944), 1974, Stroop color, Attention (WAIS-III Symbol Search; Stroop word, Fine motor, Executive (Trailmaking B, Stroop interference, Letter, Category Fluency. An overall summary score of neurocognitive functioning was created by averaging all tests. Participants also completed the self-reported functional status Patient's Assessment of Own Functioning Inventory (PAOFI) and the Activities of Daily Living Scale (ADLS). Best available demographically corrected normative data were utilized to create z scores. A negative z score denotes below-average performance relative to a US normative comparison population. A higher z score is a better outcome. |
| Secondary | Change in Overall Neurocognitive Impairment From Baseline to Week 24 or 48 | Baseline to Week 24 or 48 | Change in overall z score from baseline to week 24 or 48. A negative z score denotes below-average performance relative to a US normative comparison population. A higher z score is a better outcome. |
| Secondary | Correlation of HIV RNA Levels in CSF and Drug Levels With Neurocognitive Functioning | From enrollment through Week 48 | |
| Secondary | Correlation of Time to HIV RNA Levels <200 Copies/mL With Improvement in Neurocognitive Functioning From Baseline to Week 24 and 48 | Baseline to Week 24 and 48 | |
| Secondary | HIV RNA Detection in Ileal Biopsy Specimens | Weeks 4 and 48 | Average HIV RNA detected in the ileal biopsy specimens per participant over weeks 4 and 48. |
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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