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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01934803
Recruitment Status : Completed
First Posted : September 4, 2013
Last Update Posted : November 9, 2018
Sponsor:
Collaborator:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
Jeffrey Samet, Boston Medical Center

Brief 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.

Condition or disease Intervention/treatment Phase
HIV Infection Alcohol Use Dietary Supplement: Zinc gluconate Dietary Supplement: Placebo Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 254 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Zinc for HIV Disease Among Alcohol Users - an RCT in the Russia ARCH Cohort
Actual Study Start Date : October 2013
Actual Primary Completion Date : February 2017
Actual Study Completion Date : November 8, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Alcohol HIV/AIDS

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Improved markers of mortality as measured by change in VACS index [ Time Frame: Participants will be followed for up to 18 months ]

Secondary Outcome Measures :
  1. Slower HIV disease progression as measured by change in CD4 cell count [ Time Frame: Participants will be followed for up to 18 months ]
  2. Improved markers of AMI risk as measured by the Reynolds risk score [ Time Frame: Participants will be followed for up to 18 months ]
  3. Lower biomarker levels of microbial translocation and inflammation as measured by sCD-14, IL-6, D-dimer, IFABP, LBP [ Time Frame: Participants will be followed for up to 18 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01934803


Locations
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Russian Federation
Pavlov State Medical University
St. Peterburg, Russian Federation
Sponsors and Collaborators
Boston Medical Center
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Investigators
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Principal Investigator: Jeffrey Samet, MD, MA, MPH Boston Medical Center
Principal Investigator: Matthew S. Freiberg, MD, MSc Vanderbilt University
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jeffrey Samet, Chief, Section of General and Internal Medicine, Boston Medical Center
ClinicalTrials.gov Identifier: NCT01934803    
Other Study ID Numbers: H-31901
U01AA021989 ( U.S. NIH Grant/Contract )
First Posted: September 4, 2013    Key Record Dates
Last Update Posted: November 9, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jeffrey Samet, Boston Medical Center:
Alcohol Use
Microbial Translocation
Inflammation
Altered Coagulation
Russia
Zinc
AMI
VACS index
Reynolds risk score
Additional relevant MeSH terms:
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Alcohol Drinking
Drinking Behavior