HIV Clinical Trial
Official title:
Oral Naltrexone for Improved Medication Compliance Among HIV-infected Men With Alcohol Use Disorder
Verified date | June 2017 |
Source | Fred Hutchinson Cancer Research Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study will recruit 159 HIV-infected men with alcohol use disorders (AUDs). Men will be randomized to receive either oral naltrexone for the treatment of alcohol use disorder or placebo. Men with acute, recent or established HIV infection will receive antiretroviral treatment (ART) and be randomized to oral naltrexone or placebo. The purpose of this study is to see whether use of oral naltrexone improves medication compliance, and therefore HIV viral load suppression, among men with alcohol use disorder. The study will also assess the impact of oral naltrexone on alcohol use behaviors in this population.
Status | Completed |
Enrollment | 159 |
Est. completion date | June 2017 |
Est. primary completion date | June 2016 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Meets DSM-IV criteria for alcohol dependence or problem drinking. - Age 18 years and older - Confirmed HIV infection, either through positive HIV antibody or detectable HIV-1 RNA level. - No participation in pharmacotherapy trial in the previous 30 days - Not pregnant Exclusion Criteria: - Unable to provide informed consent - Verbally or physically threatening to research staff - Unable to communicate in Spanish - Pending trials for a felony - Childs-Pugh Class C Cirrhosis - Grade 3 Hepatitis (LFTs > 5X normal) - Receiving opioid prescription narcotics or has pain syndrome necessitating future use of opioid prescription narcotics. |
Country | Name | City | State |
---|---|---|---|
Peru | Asociación Civil Impacta Salud y Educación | Lima |
Lead Sponsor | Collaborator |
---|---|
Fred Hutchinson Cancer Research Center | Asociación Civil Impacta Salud y Educación, Peru, Yale University |
Peru,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | HIV Viral Load Suppression | The primary outcome will be the proportion with a VL<400 copies/mL at 6 months. | 6 months | |
Secondary | ART Compliance and Alcohol Use Behavior | Secondary HIV outcomes will include time to ART initiation, retention on ART over 6 months, and HIV sexual risk behaviors. Alcohol use outcomes include the following: 1) Time to relapse to heavy drinking (for men defined as >5 drinks/drinking day); 2) percent of days drinking (PDD) over the six-month examination period; 3) percent of days abstinent (PDA) over the six month examination period; and 4) alcohol craving using the Obsessive Compulsive Drinking Scale where a mean change in total score will be assessed and compared between treatment groups. | 6 months |
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