Zinc Therapy in HIV Infected Individuals Who Abuse Drugs
This study has been completed.
Sponsor:
Florida International University
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Marianna Baum, Florida International University
ClinicalTrials.gov Identifier:
NCT00149552
First received: September 6, 2005
Last updated: March 1, 2012
Last verified: March 2012
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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 |
Resource links provided by NLM:
Further study details as provided by Florida International University:
Primary Outcome Measures:
- Immune failure [ Time Frame: For at least 6 months ] [ Designated as safety issue: No ]CD4 cell count <200 cells/uL
Secondary Outcome Measures:
- 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 (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00149552
Please refer to this study by its ClinicalTrials.gov identifier: NCT00149552
Locations
| United States, Florida | |
| Camillus House | |
| Miami, Florida, United States, 33132 | |
Sponsors and Collaborators
Florida International University
National Institute on Drug Abuse (NIDA)
Investigators
| Principal Investigator: | Marianna K. Baum, PhD | Florida International University |
More Information
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 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 |
ClinicalTrials.gov processed this record on September 27, 2016