Recruitment

Recruitment Status
Completed
Estimated Enrollment
250

Inclusion Criterias

Stable address within St. Petersburg or districts within 100 kilometers of St. Petersburg;
Heavy alcohol consumption [i.e., NIAAA at-risk drinking levels] in the past 30 days
Provision of contact information for two contacts to assist with follow-up;
...
Stable address within St. Petersburg or districts within 100 kilometers of St. Petersburg;
Heavy alcohol consumption [i.e., NIAAA at-risk drinking levels] in the past 30 days
Provision of contact information for two contacts to assist with follow-up;
Possession of a home or cellular telephone
HIV-infected
ART naïve
Age 18-70 years old

Exclusion Criterias

Cognitive impairment resulting in inability to provide informed consent based on assessor assessment
Pregnancy
Breastfeeding
...
Cognitive impairment resulting in inability to provide informed consent based on assessor assessment
Pregnancy
Breastfeeding
Not fluent in Russian

Summary

Conditions
  • Alcohol Use
  • HIV Infection
Type
Interventional
Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Triple (Participant, Investigator, Outcomes Assessor)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 70 years
Gender
Both males and females

Description

The combination of heavy alcohol consumption and HIV infection is associated with increased mortality, HIV disease progression, acute myocardial infarction (AMI) and a proinflammatory state characterized by increased biomarker levels of inflammation. Heavy alcohol use and HIV infection are both caus...

The combination of heavy alcohol consumption and HIV infection is associated with increased mortality, HIV disease progression, acute myocardial infarction (AMI) and a proinflammatory state characterized by increased biomarker levels of inflammation. Heavy alcohol use and HIV infection are both causes of microbial translocation, the process by which bacterial products from the gastrointestinal (GI) tract leak across the GI membrane to the portal circulation. Microbial translocation causes immune activation leading to end organ damage. Alcohol can cause microbial translocation via zinc deficiency. Zinc deficiency is common among HIV-infected heavy drinkers and linked to high mortality rates. Zinc supplementation is affordable, available, does not interfere with ART, and has minimal adverse drug reactions. In animal models zinc reduces ethanol associated microbial translocation. In human studies zinc slows HIV disease progression and reduces levels of inflammatory biomarkers which are strongly linked to mortality. Given zinc's potential efficacy we propose to conduct Zinc for INflammation and Chronic disease in HIV (ZINC HIV), a double-blinded randomized controlled trial to assess the efficacy of zinc supplementation vs. placebo among 250 HIV+ Russians, who are ART-naive at enrollment and have a recent history of heavy drinking. We will recruit most of our participants from the Russia cohort within the Uganda Russia Boston Alcohol Network for Alcohol Research Collaboration on HIV/AIDS (URBAN ARCH) Consortium study. Our specific aims will test the efficacy of zinc supplementation, compared to placebo to (1) improve markers of mortality as measured by the VACS index; (2) slow HIV disease progression as measured by CD4 cell count; (3) improve markers of AMI risk as measured by the Reynolds risk score; and (4) lower levels of microbial translocation and inflammation as measured by serum biomarkers. We hypothesize that as compared with placebo, patients receiving zinc supplementation will have significantly lower AMI and mortality risk as measured by the VACS index and Reynolds risk scores; higher CD4 cell counts; lower levels of biomarkers for microbial translocation and inflammation. Importantly, if our hypotheses are true, zinc supplementation could ultimately become a standard adjunctive therapy complementing alcohol interventions among HIV-infected persons even in resource limited environments. PUBLIC HEALTH RELEVANCE: The combination of heavy alcohol consumption and HIV infection results in serious health problems and an increased risk of death. Although it is not exactly clear how alcohol and HIV do this, inflammation appears to play an important role. Zinc supplementation has anti-inflammatory properties. This study is designed to see if giving zinc supplementation to HIV infected people who are heavy drinkers reduces the risk of serious health problems and death.

Inclusion Criterias

Stable address within St. Petersburg or districts within 100 kilometers of St. Petersburg;
Heavy alcohol consumption [i.e., NIAAA at-risk drinking levels] in the past 30 days
Provision of contact information for two contacts to assist with follow-up;
...
Stable address within St. Petersburg or districts within 100 kilometers of St. Petersburg;
Heavy alcohol consumption [i.e., NIAAA at-risk drinking levels] in the past 30 days
Provision of contact information for two contacts to assist with follow-up;
Possession of a home or cellular telephone
HIV-infected
ART naïve
Age 18-70 years old

Exclusion Criterias

Cognitive impairment resulting in inability to provide informed consent based on assessor assessment
Pregnancy
Breastfeeding
...
Cognitive impairment resulting in inability to provide informed consent based on assessor assessment
Pregnancy
Breastfeeding
Not fluent in Russian

Locations

St. Peterburg
St. Peterburg

Tracking Information

NCT #
NCT01934803
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Investigators
  • Principal Investigator: Jeffrey Samet, MD, MA, MPH Boston Medical Center Principal Investigator: Matthew S. Freiberg, MD, MSc Vanderbilt University
  • Jeffrey Samet, MD, MA, MPH Boston Medical Center Principal Investigator: Matthew S. Freiberg, MD, MSc Vanderbilt University