| 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)
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Purpose of This Trial:
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| To compare two treatments to prevent active TB in persons with HIV and latent TB
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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
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| Medications While On Study: |
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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
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| Length of Study: |
| About 4 years (208 weeks)
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Schedule of Study Appointments: |
Screening, entry, 2, 4, 8, 12, 16, 20, 24, 36, 48, and every 12 weeks starting at week 48
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| Reimbursement: |
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Clinical Exams, the Rifapentine, Isoniazid, Vitamin B6 and lab tests are provided at no cost. You will receive $20 per visit starting at Entry.
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Contact: |
The ACTU Screening Nurse at 206-744-3184.
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