Ignite Creation Date:
2024-05-05 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00149552
Status:
COMPLETED
Last Update Posted:
2012-03-05
First Post:
2005-09-06
Brief Title:
Zinc Therapy in HIV Infected Individuals Who Abuse Drugs
Sponsor:
Florida International University
Organization:
Florida International University
Study Overview
Official Title:
Zinc Therapy in Zinc Deficient HIV Positive Drug Users
Status:
COMPLETED
Status Verified Date:
2012-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01DA014966 | NIH | None | httpsreporternihgovquickSearchR01DA014966 |