Ignite Creation Date:
2024-05-05 @ 9:18 PM
Last Modification Date:
2024-10-26 @ 10:02 AM
Study NCT ID:
NCT00854230
Status:
WITHDRAWN
Last Update Posted:
2012-03-28
First Post:
2009-03-02
Brief Title:
Pharmacotherapy for HIV Infected Patients With Alcohol Problems
Sponsor:
VA Connecticut Healthcare System
Organization:
VA Connecticut Healthcare System
Study Overview
Official Title:
Pharmacotherapy for HIV Infected Patients With Alcohol Problems
Status:
WITHDRAWN
Status Verified Date:
2012-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
We expanded to a bigger multi-site study decided to close this study
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a randomized double blind clinical trial to test the effect of Naltrexone on HIV infected heavy drinkers The study will select 40 HIV positive patients who meet criteria for heavy drinking Treatments include Naltrexone 25-100mgand placebo Patients will be treated followed up and assessed for a duration of 12 weeks
The investigators associated hypotheses Hypothesis 1 Naltrexone will reduce the frequency of heavy drinking Hypothesis 2 Naltrexone will lead to maintenance or improvement in CD4 lymphocyte count and decreased HIV RNA levels
Hypothesis 3 Naltrexone will lead to a reduction in sexual risk behaviors Hypothesis 4 Naltrexone will lead to improved adherence to HAART Hypothesis 5 Exploratory Naltrexone will be well-tolerated with minimal side effects and patients will exhibit good treatment retention
The investigators associated hypotheses Hypothesis 1 Naltrexone will reduce the frequency of heavy drinking Hypothesis 2 Naltrexone will lead to maintenance or improvement in CD4 lymphocyte count and decreased HIV RNA levels
Hypothesis 3 Naltrexone will lead to a reduction in sexual risk behaviors Hypothesis 4 Naltrexone will lead to improved adherence to HAART Hypothesis 5 Exploratory Naltrexone will be well-tolerated with minimal side effects and patients will exhibit good treatment retention
Detailed Description:
None
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 |
|---|---|---|---|
| 0901004647 | None | None | None |