Zinc for HIV Disease Among Alcohol Users - an RCT in the Russia ARCH Cohort (ZINC)
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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
:
Active, not recruiting
First Posted
: September 4, 2013
Last Update Posted
: November 6, 2017
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Condition or disease | Intervention/treatment | Phase |
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HIV Infection Alcohol Use | Dietary Supplement: Zinc gluconate Dietary Supplement: Placebo | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 250 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 |
Estimated Study Completion Date : | April 2018 |
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.
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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.
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Placebo Comparator: Placebo
Study participants will receive identically packaged placebo (sucrose) pills and will be instructed to take one pill daily for 18 months.
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Dietary Supplement: Placebo |
- Improved markers of mortality as measured by change in VACS index [ Time Frame: Participants will be followed for up to 18 months ]
- Slower HIV disease progression as measured by change in CD4 cell count [ Time Frame: Participants will be followed for up to 18 months ]
- Improved markers of AMI risk as measured by the Reynolds risk score [ Time Frame: 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, 16sRDNA [ Time Frame: Participants will be followed for up to 18 months ]

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Ages Eligible for Study: | 18 Years to 70 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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
Russian Federation | |
Pavlov State Medical University | |
St. Peterburg, Russian Federation |
Principal Investigator: | Jeffrey Samet, MD, MA, MPH | Boston Medical Center | |
Principal Investigator: | Matthew S. Freiberg, MD, MSc | Vanderbilt University |
Additional Information:
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: |
H-31901 U01AA021989 ( U.S. NIH Grant/Contract ) |
First Posted: | September 4, 2013 Key Record Dates |
Last Update Posted: | November 6, 2017 |
Last Verified: | November 2017 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
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:
HIV Infections Alcohol Drinking Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases |
Drinking Behavior Slow Virus Diseases Ethanol Zinc Anti-Infective Agents, Local Anti-Infective Agents Central Nervous System Depressants Physiological Effects of Drugs Trace Elements Micronutrients Growth Substances |