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Trial · NCT00855413

Registered outcomes38

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryNumber of Participants With Virologic Response24 weeksVirologic response defined as plasma HIV RNA measurement \<200 copies/mL at week 24
SecondaryNumber of Participants With Virologic Response48 weeks from enrollmentVirologic response to study treatment defined as plasma HIV RNA measurement \<50 copies/mL at week 48
SecondaryMedian Change in CD4 Cell Count From Week 0 to Week 24.week 0, week 24
SecondaryMedian Change in CD4 Cell Count From Week 0 to Week 48.48 weeks from enrollment
SecondaryHIV RNA Levels Immediately Prior to Initiating Study Treatment.HIV RNA level at enrollment
SecondaryMedian Time to HIV RNA Suppression to <200 Copies/mLFrom enrollment to the date of HIV RNA suppression, assessed up to Week 48
SecondaryHIV RNA Detection in SemenFrom enrollment through 48 weeksTotal cumulative levels of HIV RNA detected in the semen of participants from enrollment through week 48.
SecondaryNumber of Participants Who Stopped Study Treatment Due to Adverse Event or IntoleranceEnrollment to Week 48
SecondaryAdverse Events Possibly or Definitely Related to Study Treatment Through Week 48Enrollment to week 48Total number of adverse events observed that were possibly or definitely related to study treatment through week 48
SecondaryMaximum Etravirine Exposure in Cerebrospinal Fluid Among Participants Who Consented to an Optional Lumbar PunctureWeek 4 and week 48
SecondaryMinimum Etravirine Exposure in Cerebrospinal Fluid Among Participants Who Consented to an Optional Lumbar PunctureWeek 4 and week 48
SecondaryMaximum Darunavir Exposure in Cerebrospinal Fluid Among Participants Who Consented to an Optional Lumbar PunctureWeek 4 and week 48
SecondaryMinimum Darunavir Exposure in Cerebrospinal Fluid Among Participants Who Consented to an Optional Lumbar PunctureWeek 4 and week 48
SecondaryMaximum Ritonavir Exposure in Cerebrospinal Fluid Among Participants Who Consented to an Optional Lumbar PunctureWeek 4 and Week 48
SecondaryMinimum Ritonavir Exposure Range in Cerebrospinal Fluid Among Participants Who Consented to an Optional Lumbar PunctureWeek 4 and week 48
SecondaryMaximum Etravirine Exposure in Semen Among Participants Who Consented to an Optional Collection of SemenWeeks 0-4 and weeks 12, 48
SecondaryMinimum Etravirine Exposure in Semen Among Participants Who Consented to an Optional Collection of SemenWeeks 0-4 and weeks 12, 48
SecondaryMaximum Darunavir Exposure in Semen Among Participants Who Consented to an Optional Collection of SemenWeeks 0-4 and weeks 12, 48
SecondaryMinimum Darunavir Exposure Range in Semen Among Participants Who Consented to an Optional Collection of SemenWeeks 0-4 and weeks 12, 48
SecondaryMaximum Ritonavir Exposure in Semen Among Participants Who Consented to an Optional Collection of SemenWeeks 0-4 and Weeks 12, 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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