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

This study is currently recruiting participants.
Verified October 2013 by Boston Medical Center
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Jeffrey Samet, Boston Medical Center
ClinicalTrials.gov Identifier:
NCT01934803
First received: August 30, 2013
Last updated: October 8, 2013
Last verified: October 2013

August 30, 2013
October 8, 2013
October 2013
September 2015   (final data collection date for primary outcome measure)
Improved markers of mortality as measured by change in VACS index [ Time Frame: Participants will be followed for up to 18 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01934803 on ClinicalTrials.gov Archive Site
  • Slower HIV disease progression as measured by change in CD4 cell count [ Time Frame: Participants will be followed for up to 18 months ] [ Designated as safety issue: No ]
  • Improved markers of AMI risk as measured by the Reynolds risk score [ Time Frame: Participants will be followed for up to 18 months ] [ Designated as safety issue: No ]
  • Lower biomarker levels of microbial translocation and inflammation as measured by sCD-14, IL-6, D-dimer, 16sRDNA [ Time Frame: Participants will be followed for up to 18 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Zinc for HIV Disease Among Alcohol Users - an RCT in the Russia ARCH Cohort
Zinc for HIV Disease Among Alcohol Users - an RCT in the Russia ARCH Cohort

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.

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.

Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • HIV Infection
  • Alcohol Use
  • 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
  • Active Comparator: Zinc gluconate
    Study participants will receive zinc gluconate supplements (15 mg for men and 12 mg for women) and will be instructed to take one pill daily for 18 months.
    Intervention: Dietary Supplement: Zinc gluconate
  • Placebo Comparator: Placebo
    Study participants will receive identically packaged placebo (sucrose) pills and will be instructed to take one pill daily for 18 months.
    Intervention: Dietary Supplement: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
250
August 2017
September 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age 18-70 years old
  • HIV-infected
  • ART naïve
  • 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;
  • Possession of a home or cellular telephone

Exclusion Criteria:

  • Not fluent in Russian
  • Cognitive impairment resulting in inability to provide informed consent based on assessor assessment
  • Pregnancy
  • Breastfeeding
Both
18 Years to 70 Years
No
Contact: Jeffrey Samet, MD, MA, MPH 617-414-7288 jsamet@bu.edu
Contact: Matthew Freiberg, MD, MSc 412-586-9847 freibergms@upmc.edu
Russian Federation
 
NCT01934803
U01AA021989, U01AA021989
Yes
Jeffrey Samet, Boston Medical Center
Boston Medical Center
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Principal Investigator: Jeffrey Samet, MD, MA, MPH Boston Medical Center
Principal Investigator: Matthew S. Freiberg, MD, MSc University of Pittsburgh
Boston Medical Center
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP