A5279: Phase III Trial of TB Prevention in 3,000 HIV-Infected Adults

3,000 HIV-infected patients participated in this Phase III clinical trial conducted by the ACTG Statistical and Data Analysis Center to compare short-course and long-course tuberculosis preventive therapies. The study followed participants for a median of 3.3 years to track tuberculosis incidence, treatment completion rates, and safety outcomes.

Use Cases

• Modeling the impact of CD4+ counts on tuberculosis incidence rates
• Statistical comparison of treatment completion percentages between the 1-month and 9-month groups
• Safety analysis of serious adverse events relative to antiretroviral therapy status

Strengths

• 3,000 enrolled patients
• Median follow-up period of 3.3 years
• Phase III clinical trial standards from ACTG

Limitations

• Geographic bias toward high tuberculosis prevalence areas
• Open-label trial design may affect reporting of non-objective outcomes
• Restricted to HIV-infected adult population

Provenance

Source

ACTG Statistical and Data Analysis Center

Collection Method

Phase III randomized, open-label, noninferiority clinical trial

Time Range

Median 3.3 years follow-up

Freshness

Last updated March 2026; data reflects a completed Phase III trial.

Geography

Areas of high tuberculosis prevalence