Ignite Creation Date:
2025-12-24 @ 7:43 PM
Ignite Modification Date:
2025-12-26 @ 2:12 PM
Study NCT ID:
NCT01934803
Status:
COMPLETED
Last Update Posted:
2018-11-09
First Post:
2013-08-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Zinc for HIV Disease Among Alcohol Users - an RCT in the Russia ARCH Cohort
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D000428', 'term': 'Alcohol Drinking'}, {'id': 'D007249', 'term': 'Inflammation'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D016180', 'term': 'Lentivirus Infections'}, {'id': 'D012192', 'term': 'Retroviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D004327', 'term': 'Drinking Behavior'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C030691', 'term': 'gluconic acid'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 254}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2018-11-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-11-08', 'studyFirstSubmitDate': '2013-08-30', 'studyFirstSubmitQcDate': '2013-09-03', 'lastUpdatePostDateStruct': {'date': '2018-11-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-09-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Improved markers of mortality as measured by change in VACS index', 'timeFrame': 'Participants will be followed for up to 18 months'}], 'secondaryOutcomes': [{'measure': 'Slower HIV disease progression as measured by change in CD4 cell count', 'timeFrame': 'Participants will be followed for up to 18 months'}, {'measure': 'Improved markers of AMI risk as measured by the Reynolds risk score', 'timeFrame': 'Participants will be followed for up to 18 months'}, {'measure': 'Lower biomarker levels of microbial translocation and inflammation as measured by sCD-14, IL-6, D-dimer, IFABP, LBP', 'timeFrame': 'Participants will be followed for up to 18 months'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Alcohol Use', 'Microbial Translocation', 'Inflammation', 'Altered Coagulation', 'Russia', 'Zinc', 'AMI', 'VACS index', 'Reynolds risk score'], 'conditions': ['HIV Infection', 'Alcohol Use']}, 'referencesModule': {'references': [{'pmid': '33757560', 'type': 'DERIVED', 'citation': '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': '32383748', 'type': 'DERIVED', 'citation': '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': '29663871', 'type': 'DERIVED', 'citation': '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.'}], 'seeAlsoLinks': [{'url': 'http://www.urbanarch.org', 'label': 'Website for the Uganda, Russia, Boston Alcohol Network for Alcohol Research Collaboration on HIV/AIDS'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18-70 years old\n* HIV-infected\n* ART naïve\n* Heavy alcohol consumption \\[i.e., NIAAA at-risk drinking levels\\] in the past 30 days\n* Provision of contact information for two contacts to assist with follow-up;\n* Stable address within St. Petersburg or districts within 100 kilometers of St. Petersburg;\n* Possession of a home or cellular telephone\n\nExclusion Criteria:\n\n* Not fluent in Russian\n* Cognitive impairment resulting in inability to provide informed consent based on assessor assessment\n* Pregnancy\n* Breastfeeding'}, 'identificationModule': {'nctId': 'NCT01934803', 'acronym': 'ZINC', 'briefTitle': 'Zinc for HIV Disease Among Alcohol Users - an RCT in the Russia ARCH Cohort', 'organization': {'class': 'OTHER', 'fullName': 'Boston Medical Center'}, 'officialTitle': 'Zinc for HIV Disease Among Alcohol Users - an RCT in the Russia ARCH Cohort', 'orgStudyIdInfo': {'id': 'H-31901'}, 'secondaryIdInfos': [{'id': 'U01AA021989', 'link': 'https://reporter.nih.gov/quickSearch/U01AA021989', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Zinc gluconate', 'description': '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.', 'interventionNames': ['Dietary Supplement: Zinc gluconate']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Study participants will receive identically packaged placebo (sucrose) pills and will be instructed to take one pill daily for 18 months.', 'interventionNames': ['Dietary Supplement: Placebo']}], 'interventions': [{'name': 'Zinc gluconate', 'type': 'DIETARY_SUPPLEMENT', 'description': '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.', 'armGroupLabels': ['Zinc gluconate']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Saint Peterburg', 'country': 'Russia', 'facility': 'Pavlov State Medical University'}], 'overallOfficials': [{'name': 'Jeffrey Samet, MD, MA, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Boston Medical Center'}, {'name': 'Matthew S. Freiberg, MD, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Vanderbilt University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boston Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Alcohol Abuse and Alcoholism (NIAAA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief, Section of General and Internal Medicine', 'investigatorFullName': 'Jeffrey Samet', 'investigatorAffiliation': 'Boston Medical Center'}}}}