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

This study is currently recruiting participants. (see Contacts and Locations)
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
  Purpose

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.


Condition Intervention Phase
HIV Infection
Alcohol Use
Dietary Supplement: Zinc gluconate
Dietary Supplement: Placebo
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Zinc for HIV Disease Among Alcohol Users - an RCT in the Russia ARCH Cohort

Resource links provided by NLM:


Further study details as provided by Boston Medical Center:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 250
Study Start Date: October 2013
Estimated Study Completion Date: August 2017
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.
Placebo Comparator: Placebo
Study participants will receive identically packaged placebo (sucrose) pills and will be instructed to take one pill daily for 18 months.
Dietary Supplement: Placebo

Detailed 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 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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01934803

Contacts
Contact: Jeffrey Samet, MD, MA, MPH 617-414-7288 jsamet@bu.edu
Contact: Matthew Freiberg, MD, MSc 412-586-9847 freibergms@upmc.edu

Locations
Russian Federation
Pavlov State Medical University Recruiting
St. Peterburg, Russian Federation
Sponsors and Collaborators
Boston Medical Center
Investigators
Principal Investigator: Jeffrey Samet, MD, MA, MPH Boston Medical Center
Principal Investigator: Matthew S. Freiberg, MD, MSc University of Pittsburgh
  More Information

Additional Information:
No publications provided

Responsible Party: Jeffrey Samet, Chief, Section of General and Internal Medicine, Boston Medical Center
ClinicalTrials.gov Identifier: NCT01934803     History of Changes
Other Study ID Numbers: U01AA021989, U01AA021989
Study First Received: August 30, 2013
Last Updated: October 8, 2013
Health Authority: United States: Federal Government

Keywords provided by Boston Medical Center:
Alcohol Use
Microbial Translocation
Inflammation
Altered Coagulation
Russia
Zinc
AMI
VACS index
Reynolds risk score

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Alcohol Drinking
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Drinking Behavior
Zinc
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 18, 2014