Trial · NCT00855413
Outcomes38
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 38
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Virologic Response | 24 weeks | All participants enrolled were included in analysis of virologic response | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Virologic Response | 48 weeks from enrollment | All participants retained on study through week 48 were included in the analysis of virologic efficacy at week 48 | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Median Change in CD4 Cell Count From Week 0 to Week 24. | week 0, week 24 | All participants enrolled were included in this analysis | cells/mm^3 | MEDIAN |
| SECONDARY | Median Change in CD4 Cell Count From Week 0 to Week 48. | 48 weeks from enrollment | 12 participants with a week 48 study visit were included in analysis | cells/mm^3 | MEDIAN |
| SECONDARY | HIV RNA Levels Immediately Prior to Initiating Study Treatment. | HIV RNA level at enrollment | copies/mL | MEDIAN | |
| SECONDARY | Median Time to HIV RNA Suppression to <200 Copies/mL | From enrollment to the date of HIV RNA suppression, assessed up to Week 48 | days | MEDIAN | |
| SECONDARY | HIV RNA Detection in Semen | From enrollment through 48 weeks | Study stopped prior to target enrollment by sponsor. Given insufficient semen samples, correlation of HIV viremia in semen with time to suppression was not performed due to inadequate power to analyze the outcome. | copies/mL | MEAN |
| SECONDARY | Number of Participants Who Stopped Study Treatment Due to Adverse Event or Intolerance | Enrollment to Week 48 | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Adverse Events Possibly or Definitely Related to Study Treatment Through Week 48 | Enrollment to week 48 | adverse events | NUMBER | |
| SECONDARY | Maximum Etravirine Exposure in Cerebrospinal Fluid Among Participants Who Consented to an Optional Lumbar Puncture | Week 4 and week 48 | 4 participants consented to 7 optional lumbar punctures to provide CSF samples for measurement of drug levels. | ng/mL | NUMBER |
| SECONDARY | Minimum Etravirine Exposure in Cerebrospinal Fluid Among Participants Who Consented to an Optional Lumbar Puncture | Week 4 and week 48 | 4 participants consented to 7 optional lumbar puncture to provide CSF sample for measurement of drug levels. | ng/mL | NUMBER |
| SECONDARY | Maximum Darunavir Exposure in Cerebrospinal Fluid Among Participants Who Consented to an Optional Lumbar Puncture | Week 4 and week 48 | Four participants consented to 7 optional lumbar puncture to provide CSF sample for measurement of drug levels. | ng/mL | NUMBER |
| SECONDARY | Minimum Darunavir Exposure in Cerebrospinal Fluid Among Participants Who Consented to an Optional Lumbar Puncture | Week 4 and week 48 | Four participants consented to 7 optional lumbar puncture to provide CSF sample for measurement of drug levels. | ng/mL | NUMBER |
| SECONDARY | Maximum Ritonavir Exposure in Cerebrospinal Fluid Among Participants Who Consented to an Optional Lumbar Puncture | Week 4 and Week 48 | Four participants consented to 7 optional lumbar puncture to provide CSF sample for measurement of drug levels. | ng/mL | NUMBER |
| SECONDARY | Minimum Ritonavir Exposure Range in Cerebrospinal Fluid Among Participants Who Consented to an Optional Lumbar Puncture | Week 4 and week 48 | Four participants consented to 7 optional lumbar puncture to provide CSF sample for measurement of drug levels. | ng/mL | NUMBER |
| SECONDARY | Maximum Etravirine Exposure in Semen Among Participants Who Consented to an Optional Collection of Semen | Weeks 0-4 and weeks 12, 48 | Four participants consented to provide a semen sample for measurement of drug levels. | ng/mL | NUMBER |
| SECONDARY | Minimum Etravirine Exposure in Semen Among Participants Who Consented to an Optional Collection of Semen | Weeks 0-4 and weeks 12, 48 | Four participants consented to provide a semen sample for measurement of drug levels. | ng/mL | NUMBER |
| SECONDARY | Maximum Darunavir Exposure in Semen Among Participants Who Consented to an Optional Collection of Semen | Weeks 0-4 and weeks 12, 48 | Four participants consented to provide a semen sample for measurement of drug levels. | ng/mL | NUMBER |
| SECONDARY | Minimum Darunavir Exposure Range in Semen Among Participants Who Consented to an Optional Collection of Semen | Weeks 0-4 and weeks 12, 48 | Four participants consented to provide a semen sample for measurement of drug levels. | ng/mL | NUMBER |
| SECONDARY | Maximum Ritonavir Exposure in Semen Among Participants Who Consented to an Optional Collection of Semen | Weeks 0-4 and Weeks 12, 48 | Four participants consented to provide a semen sample for measurement of drug levels. | ng/mL | 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/NCT00855413/outcomes