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Trial · NCT00035932

Registered outcomes45

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

ListOutcomeTime frameDescription
PrimaryMean Change From Baseline in HIV Ribonucleic Acid (RNA) at Week 24Baseline, Week 24
PrimaryMean Change From Baseline in HIV RNA at Week 48Baseline, Week 48
PrimaryMean Change From Baseline in HIV RNA at Week 96Baseline, Week 96
SecondaryMean Change From Baseline in HIV RNA at Week 2Baseline, Week 2
SecondaryParticipants Achieving Virologic Half Log Suppression (Limit of Quantification [LOQ] = 400 c/mL) at Week 24 (Overall and by Protease Inhibitor [PI] Sensitivity)Baseline, Week 24Number of participants with a \>=0.5 log10 decrease in HIV RNA from baseline or HIV RNA \< 400 c/mL at Week 24, by their baseline phenotypic sensitivity to their randomized PI.
SecondaryParticipants Achieving Virologic Half Log Suppression (LOQ = 400 c/mL) at Week 48, (Overall and by PI Sensitivity)Baseline, Week 48Number of participants with a \>=0.5 log10 decrease in HIV RNA from baseline or HIV RNA \< 400 c/mL at Week 48, by their baseline phenotypic sensitivity to their randomized PI.
SecondaryParticipants Achieving Virologic Half Log Suppression (LOQ = 400 c/mL) at Week 96Baseline, Week 96Number of participants with a \>=0.5 log10 decrease in HIV RNA from baseline or HIV RNA \< 400 c/mL at Week 96.
SecondaryParticipants Achieving Virologic Half Log Suppression (LOQ = 50 c/mL) at Week 24Week 24
SecondaryParticipants Achieving Virologic Half Log Suppression (LOQ = 50 c/mL) at Week 24, by PI SensitivityBaseline, Week 24Number of participants with a \>=0.5 log10 decrease in HIV RNA from baseline or HIV RNA \< 50 c/mL at Week 24, by their baseline phenotypic sensitivity to their randomized PI.
SecondaryParticipants Achieving Virologic Half Log Suppression (LOQ = 50 c/mL) at Week 48Week 48
SecondaryParticipants Achieving Virologic Half Log Suppression (LOQ = 50 c/mL) at Week 48, by PI SensitivityBaseline, Week 48Number of participants with a \>=0.5 log10 decrease in HIV RNA from baseline or HIV RNA \< 50 c/mL at Week 48, by their baseline phenotypic sensitivity to their randomized PI.
SecondaryParticipants Achieving Virologic Half Log Suppression (LOQ = 50 c/mL) at Week 96Week 96
SecondaryParticipants Achieving Treatment Response (LOQ = 400 c/mL) Without Prior Failure at Week 24Week 24
Treatment Response = confirmed suppression to LOQ (400 c/mL). The Algorithm for Treatment Response Without Prior Failure (TRPWF) = participants staying in response at the analysis timepoint without having an intervening, confirmed rebound.
SecondaryParticipants Achieving Treatment Response (LOQ = 400 c/mL) Without Prior Failure at Week 48Week 48
Treatment Response = confirmed suppression to LOQ (400 c/mL). The Algorithm for Treatment Response Without Prior Failure (TRPWF) = participants staying in response at the analysis timepoint without having an intervening, confirmed rebound.
SecondaryParticipants Achieving Treatment Response (LOQ = 400 c/mL) Without Prior Failure at Week 96Week 96
Treatment Response = confirmed suppression to LOQ (400 c/mL). The Algorithm for Treatment Response Without Prior Failure (TRPWF) = participants staying in response at the analysis timepoint without having an intervening, confirmed rebound.
SecondaryParticipants Achieving Treatment Response (LOQ = 50 c/mL) Without Prior Failure at Week 24Week 24
Treatment Response = confirmed suppression to LOQ (50 c/mL). The Algorithm for Treatment Response Without Prior Failure (TRPWF) = participants staying in response at the analysis timepoint without having an intervening, confirmed rebound.
SecondaryParticipants Achieving Treatment Response (LOQ = 50 c/mL) Without Prior Failure at Week 48Week 48
Treatment Response = confirmed suppression to LOQ (50 c/mL). The Algorithm for Treatment Response Without Prior Failure (TRPWF) = participants staying in response at the analysis timepoint without having an intervening, confirmed rebound.
SecondaryParticipants Achieving Treatment Response (LOQ = 50 c/mL) Without Prior Failure at Week 96Week 96
Treatment Response = confirmed suppression to LOQ (50 c/mL). The Algorithm for Treatment Response Without Prior Failure (TRPWF) = participants staying in response at the analysis timepoint without having an intervening, confirmed rebound.
SecondaryChange From Baseline in CD4 Cell Count at Week 24Baseline, Week 24
SecondaryChange From Baseline in CD4 Cell Count at Week 48Baseline, Week 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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