Featuring results from a phase 3, open-label, randomized controlled equivalence trial involving 1809 treatment-naive participants infected with HIV-1. The trial evaluated the virologic efficacy and tolerability of three nonnucleoside reverse transcriptase inhibitor-sparing antiretroviral regimens over at least 96 weeks of follow-up. It was conducted across 57 sites in the United States and Puerto Rico.
Use Cases
- Analyze the incidence of virologic failure, defined by confirmed HIV-1 RNA level thresholds, across different treatment regimens.
- Compare tolerability failure rates, defined by discontinuation of specific drugs like atazanavir, raltegravir, or darunavir for toxicity.
- Investigate the combined secondary endpoint of virologic efficacy and tolerability to assess regimen superiority.
- Examine the frequency of antiretroviral resistance at the time of virologic failure, noted as more frequent with the raltegravir regimen.
Strengths
- Dataset is based on a large-scale clinical trial with 1809 participants.
- Trial design includes a randomized, controlled equivalence study with follow-up for at least 96 weeks.
- Data collection was conducted across 57 clinical sites, providing a multi-center perspective.
Limitations
- The trial was open-label, which may introduce bias in participant or assessor behavior.
- The ritonavir component of the regimens was not provided by the trial, potentially affecting real-world adherence data.
- Specific column definitions, sample data, and dataset size are not provided in the input.
Provenance
- Source
- ACTG Statistical and Data Analysis Center, Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
- Collection Method
- Data collected from a phase 3, open-label, randomized controlled clinical trial (ClinicalTrials.gov: NCT00811954).
- Time Range
- Follow-up period of at least 96 weeks for participants.
- Freshness
- null
- Geography
- 57 sites in the United States and Puerto Rico.