Phase 4
N=302
Alcohol Drinkers' Exposure to Preventive Therapy for TB (ADEPTT)
Tuberculosis · HIV/AIDS · Alcohol Abuse
Bottom Line
View on ClinicalTrials.gov: NCT03302299 ↗Enrolled (actual)
302
Serious AEs
3.7%
Results posted
Oct 2023
Primary outcome: Primary: Cumulative Incidence of Participants Experiencing a Grade 3/4 Hepatotoxicity — 8.3 percent
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Isoniazid 300 Mg ORAL TABLET (Drug); Pyridoxine 25 Mg Oral Tablet (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of California, San Francisco
- Primary completion
- Apr 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cumulative Incidence of Participants Experiencing a Grade 3/4 Hepatotoxicity |
8.3 | — |
| SECONDARY Number of Participants Who Discontinued Treatment |
32 | — |
| SECONDARY Percentage of Participants With Suboptimal INH Medication Adherence |
31.3; 43.9 | <0.01 sig |
| SECONDARY Self-reported INH Medication Adherence: Number of Days Taking INH in the Past 30 Days |
30; 30 | — |
| SECONDARY Self-reported INH Medication Adherence by the Self Rating Single Item (SRSI) Scale |
160; 79; 38; 0; 2; 0 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Age > 18 years old
- Patient of the MRRH ISS Clinic
- HIV-infected
- Consume alcohol (self-reported consumption in the prior 3 months) (2/3) OR prior year non-drinker (1/3)
- Live within 2 hours of travel time to the ISS Clinic
- Fluent in either Runyankole or English
- No ALT/AST elevations ( 2x ULN
- Pregnant women
Data sourced from ClinicalTrials.gov (NCT03302299). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.