5279: TB Prevention Study
5279 FACT SHEET
A Phase III Clinical Trial of Ultra-Short-Course Rifapentine/Isoniazid for the Prevention of Active Tuberculosis in HIV-Infected Individuals with Latent Tuberculosis Infection(ACTG 5279)
Purpose of This Trial:
To compare two treatments to prevent active TB in persons with HIV and latent TB
You may be eligible if you are:
  • HIV positive man or woman, age 18 or older
  • Have a positive Tuberculin skin test ≥ 5mm or a positive interferon gamma release assay(IGRA) at any time prior to study entry
  • No history of treatment for Tuberculosis in last two years
  • No history of multi–drug-resistant or extensively drug resistant (XDR) TB
  • Not on Protease Inhibitor or Raltegravir based anti-retroviral regimen or planning to start one of these regimens within 4 weeks of entry
  • Not pregnant, breast feeding or planning pregnancy (if a woman)
  • Do not have cirrhosis or recent acute hepatitis

 

Medications While On Study:
Rifapentine, Isoniazid and vitamin B6 (pyridoxine) will be provided while on study. Subjects will take Rifapentine/Isoniazid plus B6 for 4 weeks or Isoniazid plus vitamin B6 for 9 months
Length of Study:

About 4 years (208 weeks)

 

Schedule of Study Appointments:
Screening, entry, 2, 4, 8, 12, 16, 20, 24, 36, 48, and every 12 weeks starting at week 48
Reimbursement:
Clinical Exams, the Rifapentine, Isoniazid, Vitamin B6 and lab tests are provided at no cost. You will receive $20 per visit starting at Entry.
Contact:
The ACTU Screening Nurse at 206-744-3184.