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

NCT01934803 | Completed DMC

• 2 other identifiers: H-31901U01AA021989
• Study Type: interventional
• Target: 254
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV Infection; Alcohol Use

Keywords

Alcohol Use; Microbial Translocation; Inflammation; Altered Coagulation; Russia; Zinc; AMI; VACS index; Reynolds risk score

Outcome Measures

Primary Outcomes (1)

• Improved markers of mortality as measured by change in VACS index

  Participants will be followed for up to 18 months

Secondary Outcomes (3)

• Slower HIV disease progression as measured by change in CD4 cell count

  Participants will be followed for up to 18 months

• Improved markers of AMI risk as measured by the Reynolds risk score

  Participants will be followed for up to 18 months

• Lower biomarker levels of microbial translocation and inflammation as measured by sCD-14, IL-6, D-dimer, IFABP, LBP

  Participants will be followed for up to 18 months

Study Arms (2)

Zinc gluconate

ACTIVE COMPARATOR

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

Placebo

PLACEBO COMPARATOR

Study participants will receive identically packaged placebo (sucrose) pills and will be instructed to take one pill daily for 18 months.

Dietary Supplement: Placebo

Interventions

Zinc gluconate DIETARY_SUPPLEMENT

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.

Zinc gluconate

Placebo DIETARY_SUPPLEMENT

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Boston Medical Center: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

Pavlov State Medical University

Saint Peterburg, Russia

Location

Related Publications (3)

• Lodi S, Freiberg M, Gnatienko N, Blokhina E, Yaroslavtseva T, Krupitsky E, Murray E, Samet JH, Cheng DM. Per-protocol analysis of the ZINC trial for HIV disease among alcohol users. Trials. 2021 Mar 23;22(1):226. doi: 10.1186/s13063-021-05178-9.

  PMID: 33757560 DERIVED

• Freiberg MS, Cheng DM, Gnatienko N, Blokhina E, Coleman SM, Doyle MF, Yaroslavtseva T, Bridden C, So-Armah K, Tracy R, Bryant K, Lioznov D, Krupitsky E, Samet JH. Effect of Zinc Supplementation vs Placebo on Mortality Risk and HIV Disease Progression Among HIV-Positive Adults With Heavy Alcohol Use: A Randomized Clinical Trial. JAMA Netw Open. 2020 May 1;3(5):e204330. doi: 10.1001/jamanetworkopen.2020.4330.

  PMID: 32383748 DERIVED

• Gnatienko N, Freiberg MS, Blokhina E, Yaroslavtseva T, Bridden C, Cheng DM, Chaisson CE, Lioznov D, Bendiks S, Koerbel G, Coleman SM, Krupitsky E, Samet JH. Design of a randomized controlled trial of zinc supplementation to improve markers of mortality and HIV disease progression in HIV-positive drinkers in St. Petersburg, Russia. HIV Clin Trials. 2018 Jun;19(3):101-111. doi: 10.1080/15284336.2018.1459344. Epub 2018 Apr 17.

  PMID: 29663871 DERIVED

Related Links

• Website for the Uganda, Russia, Boston Alcohol Network for Alcohol Research Collaboration on HIV/AIDS

MeSH Terms

Conditions

HIV Infections; Alcohol Drinking; Inflammation

Interventions

gluconic acid

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Drinking Behavior; Behavior; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jeffrey Samet, MD, MA, MPH

  Boston Medical Center

  PRINCIPAL INVESTIGATOR

• Matthew S. Freiberg, MD, MSc

  Vanderbilt University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Section of General and Internal Medicine

Study Record Dates

• First Submitted: August 30, 2013
• First Posted: September 4, 2013
• Study Start: October 1, 2013
• Primary Completion: February 1, 2017
• Study Completion: November 8, 2018
• Last Updated: November 9, 2018

Record last verified: 2018-11

Locations

RU (1)