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 : Active, not recruiting
First Posted : September 4, 2013
Last Update Posted : July 13, 2018
|Condition or disease||Intervention/treatment||Phase|
|HIV Infection Alcohol Use||Dietary Supplement: Zinc gluconate Dietary Supplement: Placebo||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||254 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|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 :||October 2018|
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
- 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, IFABP, LBP [ Time Frame: Participants will be followed for up to 18 months ]
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
|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|