Comprising results from a Phase III randomized clinical trial (ACTG 320) involving 1156 HIV-infected adults with ≤200 CD4 cells/mm³ and prior zidovudine exposure. The study compared treatment with the protease inhibitor indinavir plus zidovudine (or stavudine) and lamivudine against the two nucleosides alone. Primary endpoints included time to AIDS development or death, with clinical and biomarker outcomes reported.
Use Cases
- Analyze the hazard ratio for disease progression (AIDS or death) between the indinavir and control treatment arms.
- Compare mortality rates and CD4 cell count responses across the two CD4 cell strata (≤50 vs. 51-200 cells/mm³).
- Model the relationship between plasma HIV-1 RNA levels and clinical outcomes like disease progression.
- Assess the efficacy of substituting stavudine for zidovudine within the treatment regimens.
Strengths
- Data from a large, randomized Phase III trial with 1156 enrolled patients.
- Study design includes double-blinding and stratification by baseline CD4 cell count.
- Clinical results are supported by biomarker data (CD4 cell counts and plasma HIV-1 RNA).
Limitations
- Patient population is specific to those with ≤200 CD4 cells/mm³ and prior zidovudine exposure, limiting generalizability.
- Data reflects treatment protocols and outcomes from the mid-1990s, which may not represent current standards.
- The raw dataset structure, including available variables and file formats, is not described.
Provenance
- Source
- ACTG Statistical and Data Analysis Center, Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections.
- Collection Method
- Data collected from a randomized, double-blind Phase III clinical trial.
- Time Range
- Study published in 1997 (N Engl J Med 1997;337:725-33).
- Freshness
- null
- Geography
- null