Zinc Therapy in HIV Infected Individuals Who Abuse Drugs
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ClinicalTrials.gov Identifier: NCT00149552 |
Recruitment Status
:
Completed
First Posted
: September 8, 2005
Last Update Posted
: March 5, 2012
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV Infections Substance-Related Disorders | Dietary Supplement: zinc | Not Applicable |
Low levels of zinc are associated with an increased risk of HIV-related death and opportunistic infections in HIV infected individuals. Drug users are especially susceptible to zinc deficiency. The purpose of this trial is to evaluate the effectiveness of zinc therapy in preventing immune failure in HIV infected individuals who abuse drugs.
This trial will last 30 months. Participants will be randomly assigned to receive either zinc supplements or placebo. Male participants will receive 15 mg of zinc and female participants will receive 12 mg of zinc. Clinical and laboratory study visits will occur at 3 or 6 month intervals throughout the study.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 231 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | Zinc Therapy in Zinc Deficient HIV Positive Drug Users |
Study Start Date : | June 2001 |
Actual Study Completion Date : | January 2007 |
Arm | Intervention/treatment |
---|---|
Active Comparator: Zinc gluconate
Zinc supplementation
|
Dietary Supplement: zinc
supplementation with zinc gluconate
|
Placebo Comparator: Placebo
Placebo
|
Dietary Supplement: zinc
supplementation with zinc gluconate
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- Immune failure [ Time Frame: For at least 6 months ]CD4 cell count <200 cells/uL
- Morbidity [ Time Frame: For at least 6 months ]AIDS related morbidity

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- HIV infected
- Drug User
- Blood zinc level greater than 0.35 mcg/mL and less than 0.75mcg/ml
Exclusion Criteria:
- Currently participating in an another clinical trial
- Blood selenium level less than 85 mcg/L
- Pregnant or intends to become pregnant

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): NCT00149552
United States, Florida | |
Camillus House | |
Miami, Florida, United States, 33132 |
Principal Investigator: | Marianna K. Baum, PhD | Florida International University |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Marianna Baum, Professor, Florida International University |
ClinicalTrials.gov Identifier: | NCT00149552 History of Changes |
Other Study ID Numbers: |
NIDA-14966-1 R01DA014966 ( U.S. NIH Grant/Contract ) |
First Posted: | September 8, 2005 Key Record Dates |
Last Update Posted: | March 5, 2012 |
Last Verified: | March 2012 |
Keywords provided by Marianna Baum, Florida International University:
Treatment Naive Treatment Experienced |
Additional relevant MeSH terms:
HIV Infections Substance-Related Disorders Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes |
Immune System Diseases Chemically-Induced Disorders Mental Disorders Zinc Trace Elements Micronutrients Growth Substances Physiological Effects of Drugs |