Status:
COMPLETED
Alcohol Drinkers' Exposure to Preventive Therapy for TB (ADEPTT)
Lead Sponsor:
University of California, San Francisco
Collaborating Sponsors:
Boston University
Boston Medical Center
Conditions:
Tuberculosis
HIV/AIDS
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 d...
Detailed Description
Tuberculosis (TB) is the leading cause of mortality in persons with HIV worldwide, accounting for 20-33% of HIV-related deaths, and is a high-priority area of research in HIV/AIDS by the NIH. TB preve...
Eligibility Criteria
Inclusion
- 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) confirmed by testing
- On ART for at least 6 months
- No history of active TB, TB treatment, or TB preventive therapy
- No probable current active TB as determined by symptom screening and followed by chest X-ray and Xpert MTB/RIF (if symptomatic)
- Positive TST results confirmed by testing
Exclusion
- Plans to move out of the catchment area within 6 months
- Probable TB via symptom screen and subsequent assessments
- History or current or past active TB, TB treatment, or TB preventive therapy
- ALT or AST \>2x ULN
- Pregnant women
Key Trial Info
Start Date :
April 7 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2021
Estimated Enrollment :
302 Patients enrolled
Trial Details
Trial ID
NCT03302299
Start Date
April 7 2017
End Date
April 1 2021
Last Update
October 19 2023
Active Locations (1)
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1
Mbarara University of Science and Technology/Mbarara Regional Referral Hospital
Mbarara, Uganda