A5279: Phase III Clinical Trial of Ultra-Short-Course Rifapentine/Isoniazid for the Prevention of Active Tuberculosis in HIV-infected Individuals with Latent Tuberculosis Infection

This study ended April 27, 2015; it was conducted under the AIDS Clinical Trials Group (ACTG) and funded by the U.S. National Institutes of Health.

Dr. Amita Gupta was Protocol Co-Vice Chair for this multinational clinical trial being conducted in Botswana, Brazil, Haiti, Kenya, Malawi, Peru, Puerto Rico, South Africa, Tanzania, Thailand, Uganda, United States, Zambia, Zimbabwe, and India by the Baltimore-Washington-India Clinical Trials Unit, of which CCGHE is a member.

The World Health Organization (WHO) estimates that in 2009 there were 9.4 million new cases of TB, and 1.68 million people died as a result of TB. Among new TB cases, 1.1 million occurred in people who were HIV-coinfected, and 35% of TB deaths were among HIV-coinfected individuals. In Africa, TB is the leading AIDS-related opportunistic infection. Latent TB infection occurs when people are infected with the bacteria that cause TB, but they do not have any symptoms of TB infection. Latent TB can develop into active TB, and HIV-infected people have an increased risk of progressing from latent TB to active TB. INH is a medication that is prescribed for people with latent TB to help prevent active TB from developing. The standard INH treatment regimen is 6 to 9 months; a shorter treatment regimen may prove to be as effective and may improve adherence. The purpose of this study is to compare the safety and effectiveness of a 4-week daily regimen of RPT plus INH to a standard 9-month daily INH regimen for TB prevention in HIV-infected individuals.

This study will enroll HIV-infected people who do not have evidence of active TB but who are at high risk of developing active TB. Participants will be randomly assigned to receive RPT and INH once a day for 4 weeks or INH once a day for 9 months. All participants will receive pyridoxine (vitamin B6) with each dose of INH to help prevent possible side effects. Study visits will occur at baseline and Weeks 2, 4, 8, 12, 16, 20, 24, and 36. At select study visits, participants will undergo a physical exam, clinical assessment, blood collection, and a chest radiograph or chest computed tomography (CT) scan (if needed). Some participants will have their blood stored for future testing. Follow-up study visits will occur every 12 weeks starting at Week 48 and will continue for 3 years after the last participant is enrolled.