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Trial · NCT00552240

Registered outcomes48

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

ListOutcomeTime frameDescription
PrimaryNumber of Participants With Virologic Response (VR)baseline to week 48VR is defined as HIV viral load of \<50 copies/ml measured at two consecutive visits PRIOR TO Week 48 and without subsequent rebound or change of ARV therapy prior to Week 48.
SecondaryNumber of Participants With Virologic Response According to the Time to Loss of Virologic Response (TLOVR) Algorithmbaseline to week 48HIV viral load \<50 copies/ml measured at two consecutive visits UP TO Week 48 and without subsequent rebound or change of ARV therapy up to Week 48.
SecondaryNumber of Participants With HIV Viral Load < 50 Copies/ml at Week 48baseline to week 48HIV viral load \<50 copies/ml measured at Week 48 among observed cases on-treatment.
SecondaryNumber of Participants With Virologic Success (FDA Definition)baseline to week 48
HIV viral load \<50 copies/ml measured in the Week 48 window whereby patients withdrawing early and patients without a Week 48 assessment are considered failures. Includes all participants in full analysis set (FAS).
SecondaryTime to Virologic Response (First Confirmed Viral Load < 50 Copies/ml), All Participantsbaseline to week 48Time to response whereby patients withdrawing early were censored after their withdrawal
SecondaryTime to Virologic Response (First Confirmed Viral Load < 50 Copies/ml), Only Participants With Confirmed Viral Load < 50 Copies/mlbaseline to week 48
SecondaryNumber of Participants With Loss of Virologic Response Following Confirmed Virologic Responsebaseline to week 24 and week 48HIV viral load \> 50 copies/ml on two consecutive measurements separated by at least 2 weeks, after confirmed virologic response (2 consecutive HIV viral load values \< 50 copies/ml)
SecondaryNumber of Participants With HIV Viral Load < 50 Copies/ml at Week 2 of Treatmentbaseline to week 2Results within time windows, patients on-treatment
SecondaryNumber of Participants With HIV Viral Load < 50 Copies/ml at Week 4 of Treatmentbaseline to week 4Results within time windows, patients on-treatment
SecondaryNumber of Participants With HIV Viral Load < 50 Copies/ml at Week 6 of Treatmentbaseline to week 6Results within time windows, patients on-treatment
SecondaryNumber of Participants With HIV Viral Load < 50 Copies/ml at Week 8 of Treatmentbaseline to week 8Results within time windows, patients on-treatment
SecondaryNumber of Participants With HIV Viral Load < 50 Copies/ml at Week 12 of Treatmentbaseline to week 12Results within time windows, patients on-treatment
SecondaryNumber of Participants With HIV Viral Load < 50 Copies/ml at Week 24 of Treatmentbaseline to week 24Results within time windows, patients on-treatment
SecondaryNumber of Participants With HIV Viral Load < 50 Copies/ml at Week 36 of Treatmentbaseline to week 36Results within time windows, patients on-treatment
SecondaryNumber of Participants With HIV Viral Load < 50 Copies/ml at Week 48 of Treatmentbaseline to week 48Results within time windows, patients on-treatment
SecondaryNumber of Participants With HIV Viral Load < 400 Copies/ml at Week 2 of Treatmentbaseline to week 2Results within time windows, patients on-treatment
SecondaryNumber of Participants With HIV Viral Load < 400 Copies/ml at Week 4 of Treatmentbaseline to week 4Results within time windows, patients on-treatment
SecondaryNumber of Participants With HIV Viral Load < 400 Copies/ml at Week 6 of Treatmentbaseline to week 6Results within time windows, patients on-treatment
SecondaryNumber of Participants With HIV Viral Load < 400 Copies/ml at Week 8 of Treatmentbaseline to week 8Results within time windows, patients on-treatment
SecondaryNumber of Participants With HIV Viral Load < 400 Copies/ml at Week 12 of Treatmentbaseline to week 12Results within time windows, patients on-treatment

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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