Alcohol Drinkers' Exposure to Preventive Therapy for TB (ADEPTT)

• Status: Completed
• Trial end date: 2021-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The Alcohol Drinkers' Exposure to Preventive Therapy for TB (ADEPTT) will examine the safety and tolerability of, and adherence to, 6 months of daily INH (6H) in 300 TB and HIV-infected persons (200 drinkers and 100 non-drinkers) in Uganda. The first aim is to evaluate the safety and tolerability of 6H overall and by level of alcohol use. The second aim is to estimate adherence and compare adherence by level of alcohol use and at 3 and 6 months. Self-reported measures of alcohol use will be augmented by phosphatidylethanol (PEth), an established biomarker of alcohol use. Objective measures of adherence will include electronic pill bottle monitoring and a novel measure of INH exposure, INH concentration in hair. The study will actively monitor for hepatotoxicity using the U.S. standard of care for TB preventive therapy for heavy drinkers and discontinue if any Grade 3/4 toxicities are detected. The investigators will use the safety, tolerability, and adherence results, together with the known efficacy and mortality benefit of TB preventive therapy in HIV-infected persons in SSA, and an established decision analytic model of TB preventive therapy to conduct the third aim: to determine whether the benefits of TB preventive therapy outweigh the toxicity risks for HIV-infected drinkers in resource limited settings. The study will additionally follow the cohort every 6 months after completing INH to monitor drinking and the development of active TB.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of California, San Francisco
• Collaborators: Boston Medical Center; Boston University; Mbarara University of Science and Technology
• Treatments: Isoniazid; Pyridoxal; Pyridoxine; Vitamin B 6; Vitamins

Criteria

Inclusion Criteria:

1. Age > 18 years old

2. Patient of the MRRH ISS Clinic

3. HIV-infected

4. Consume alcohol (self-reported consumption in the prior 3 months) (2/3) OR prior year non-drinker (1/3)

5. Live within 2 hours of travel time to the ISS Clinic

6. Fluent in either Runyankole or English

7. No ALT/AST elevations (< = 2X ULN) confirmed by testing

8. On ART for at least 6 months

9. No history of active TB, TB treatment, or TB preventive therapy

10. No probable current active TB as determined by symptom screening and followed by chest X-ray and Xpert MTB/RIF (if symptomatic)

11. Positive TST results confirmed by testing

Exclusion Criteria:

1. Plans to move out of the catchment area within 6 months

2. Probable TB via symptom screen and subsequent assessments

3. History or current or past active TB, TB treatment, or TB preventive therapy

4. ALT or AST >2x ULN

5. Pregnant women