Zinc Therapy in HIV Infected Individuals Who Abuse Drugs
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Purpose
Zinc deficiency is prevalent in HIV infected individuals who abuse drugs. The purpose of this study is to determine if zinc therapy will prevent immune failure in HIV infected individuals who abuse drugs and have low plasma zinc levels.
| Condition | Intervention |
|---|---|
|
HIV Infections Substance-Related Disorders |
Dietary Supplement: zinc |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | Zinc Therapy in Zinc Deficient HIV Positive Drug Users |
- Immune failure [ Time Frame: For at least 6 months ] [ Designated as safety issue: No ]CD4 cell count <200 cells/uL
- Morbidity [ Time Frame: For at least 6 months ] [ Designated as safety issue: No ]AIDS related morbidity
| Enrollment: | 231 |
| Study Start Date: | June 2001 |
| Study Completion Date: | January 2007 |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Zinc gluconate
Zinc supplementation
|
Dietary Supplement: zinc
supplementation with zinc gluconate
|
|
Placebo Comparator: Placebo
Placebo
|
Dietary Supplement: zinc
supplementation with zinc gluconate
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| 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
Contacts and Locations| United States, Florida | |
| Camillus House | |
| Miami, Florida, United States, 33132 | |
| Principal Investigator: | Marianna K. Baum, PhD | Florida International University |
More Information
No publications provided by Florida International University
Additional 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 |
| Study First Received: | September 6, 2005 |
| Last Updated: | March 1, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by Florida International University:
|
Treatment Naive Treatment Experienced |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome 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 Slow Virus Diseases Mental Disorders Zinc Trace Elements Micronutrients Growth Substances Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 17, 2013