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Zinc for HIV Disease Among Alcohol Users - an RCT in the Russia ARCH Cohort

NCT01934803 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 254

Last updated 2018-11-09

No results posted yet for this study

Summary

This study is a double-blinded randomized controlled trial (RCT) to assess the efficacy of zinc supplementation vs. placebo among 250 HIV-infected Russians from the Russia ARCH Cohort, who are ART-naive at enrollment and have a recent history of heavy drinking.

Conditions

  • HIV Infection
  • Alcohol Use

Interventions

DIETARY_SUPPLEMENT

Zinc gluconate

Study participants will be randomly assigned to a zinc gluconate or placebo group and will be instructed to take one pill of study medication orally daily for 18 months.

DIETARY_SUPPLEMENT

Placebo

Sponsors & Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

    collaborator NIH

  • Boston Medical Center

    lead OTHER

Principal Investigators

  • Jeffrey Samet, MD, MA, MPH · Boston Medical Center

  • Matthew S. Freiberg, MD, MSc · Vanderbilt University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-10-31
Primary Completion
2017-02-28
Completion
2018-11-08

Countries

  • Russia

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01934803 on ClinicalTrials.gov