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

Tuberculosis Clinical Trial

— ADEPTT  

Official title:

URBAN ARCH (3/5) Uganda Cohort TB Preventive Therapy for HIV-infected Alcohol Users in Uganda: an Evaluation of Safety Tolerability and Adherence

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03302299
• Other study ID #: 2U01AA020776-06
• Status: Completed
• Phase: Phase 4
• Start date: April 7, 2017
• Est. completion date: April 1, 2021

Study information

• Verified date: September 2023
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 preventive therapy decreases both all-cause mortality and active TB in persons with HIV by 30-50% above and beyond the benefits of antiretroviral therapy (ART) alone. Based on these findings, the World Health Organization (WHO) recommends isoniazid (INH) preventive therapy (IPT) for all persons with HIV in resource constrained settings. However, the WHO warns against the use of IPT in persons with "regular and heavy alcohol use." This exclusion stems from concern for increased hepatotoxicity in heavy drinkers in settings where liver enzymes are not routinely monitored. Heavy drinking in persons with HIV is very common, approximately 25%, in sub-Saharan Africa (SSA). Heavy drinking increases the risk for active TB at least threefold; thus, HIV-infected alcohol users should be prioritized for TB prevention. However, no studies have systematically assessed the safety of TB preventive therapy in heavy drinkers with or without HIV infection. It is critical to examine the safety and tolerability of TB preventive therapy for HIV-infected drinkers, given the high rates of HIV, TB infection, and alcohol comorbidities worldwide. While the risk of toxicity exists, the risk of TB disease could outweigh the toxicity harms. Thus, it is also crucial to determine whether the mortality benefits outweigh the toxicity risks for this significant portion of the HIV-infected population. In addition, TB preventive therapy is only effective if taken consistently for the full course. Alcohol use is an established risk factor for decreased ART pill taking and active TB treatment discontinuation. Whether HIV-infected drinkers on ART can be adherent to TB preventive therapy is not known. Therefore it is essential to determine the level of adherence to TB preventive therapy by HIV-infected drinkers on ART, thus this study aims to examine adherence to TB preventative therapy as well. This is a study to examine 6 months of daily INH (6H) among N=300 persons co-infected with HIV and TB. The aims of the study are: Aim 1: To examine the safety and tolerability of 6H in HIV/TB co-infected drinkers, measured by hepatotoxicity and treatment discontinuation rates. The main aim is to estimate safety and tolerability overall among drinkers (primary) and by level of drinking (secondary). Aim 2: To determine the level of TB preventive therapy adherence overall among drinkers and by level of drinking, and at 3 and 6 months. The main goal of this aim is to estimate adherence overall among drinkers (primary). Secondarily the investigators will estimate adherence by level of drinking (heavy, current but not heavy drinkers, and non-drinkers) and compare adherence across drinking levels. The investigators hypothesize that adherence will be highest among the non-drinkers. Aim 3: To determine whether the benefits of providing TB preventive therapy to HIV-infected drinkers in resource-limited settings outweigh the risks compared to no treatment. The investigators hypothesize that providing TB preventive therapy will result in longer life expectancy and quality-adjusted life expectancy than not providing TB preventive therapy (current standard of care).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 302
• Est. completion date: April 1, 2021
• Est. primary completion date: April 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alcohol Abuse
• Alcoholism
• HIV/AIDS
• Tuberculosis

Intervention

Drug:
• Isoniazid 300 Mg ORAL TABLET
The study intervention will include a single arm given (1) 6H: 300 mg INH daily by mouth for 6 months.
• Pyridoxine 25 Mg Oral Tablet
All participants will also receive 25 mg pyridoxine (vitamin B-6) daily by mouth for 6 months for the treatment duration to reduce the risk of INH-induced peripheral neuropathy.

Locations

Country	Name	City	State
Uganda	Mbarara University of Science and Technology/Mbarara Regional Referral Hospital	Mbarara

Sponsors (4)

Lead Sponsor	Collaborator
University of California, San Francisco	Boston Medical Center, Boston University, Mbarara University of Science and Technology

Country where clinical trial is conducted

Uganda, 

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* Note: There are 116 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	INH Concentration in Hair: (INH Pmol + Acetyl INH Pmol) Per mg of Hair	INH concentration in hair (pmol/mg) will be measured at 3- and 6- months during INH therapy.	Measured at 3- and 6- months after INH initiation
Other	Number of Participants With Alanine Transaminase (ALT) or Aspartate Transaminase (AST) Elevations at Study Screening	Alanine transaminase (ALT) or aspartate transaminase (AST) elevations (>2x the upper limit of normal) at study screening	Study screening visit
Other	Number of Participants With Latent Tuberculosis at Study Screening.	Latent tuberculosis assessed at screening via tuberculin skin testing (TST). A TST induration >=5mm was considered positive for latent tuberculosis.	Study screening visit
Primary	Cumulative Incidence of Participants Experiencing a Grade 3/4 Hepatotoxicity	Safety will be assessed by the occurrence of a Grade 3/4 hepatotoxicity at any time during the assigned treatment period.	Hepatotoxicity occurring during the six month course (180 pills) of isoniazid (INH), which may be taken over a maximum of 9 months.
Secondary	Number of Participants Who Discontinued Treatment	Lack of tolerability will be defined as any isoniazid (INH) treatment discontinuation prior to completion of the prescribed course (6 months of INH taken over a maximum period of 9 months) due to side effects or alanine transaminase (ALT)/aspartate transaminase (AST) elevations.	Six month course (180 pills) of isoniazid (INH), which may be taken over a maximum of 9 months.
Secondary	Percentage of Participants With Suboptimal INH Medication Adherence	Suboptimal INH adherence was defined as <90% of days with at least 1 electronic medication management (EMM) pill cap opening in the previous 90 days, at 3- and 6-months.	Adherence will be measured over the 6 months on INH or until INH discontinuation (whichever is shorter)
Secondary	Self-reported INH Medication Adherence: Number of Days Taking INH in the Past 30 Days	Participants were asked "In the past 30 days, how many days in total have you not taken your pill?" and were presented with a visual analog scale (VAS) to indicate the percentage of INH taken in the past 30 days. We converted the VAS percentage into number of days out of 30 to match the first question. Our final self-report measure was the minimum number of the 2 self-reported measurements.	Self-reported INH medication adherence via VAS will be measured 3- and 6- months after starting INH
Secondary	Self-reported INH Medication Adherence by the Self Rating Single Item (SRSI) Scale	The Self Rating Single Item (SRSI) adherence scale asks participants to rate their ability to take their medications as prescribed over the past 30 days. Participants reporting INH use in the prior 30 days at the 3- or 6-month interview are included here, and reported their INH adherence in the prior 30 days as excellent, very good, good, fair, poor, or very poor.	Self-reported INH medication adherence via SRSI will be measured 3- and 6- months after starting INH

External Links

•   Global Status Report on Alcohol and Health. Geneva: World Health Organization;2014
•   Guidelines for intensified tuberculosis case-finding and isoniazid preventive therapy for people living with HIV in resource-constrained settings.
•   How AIDS Changed Everything: 2014 Global Statistics. UNAIDS;2015.
•   UNAIDS Country Report, Uganda. 2014