HIVPhase 4NCT01377168
Naltrexone for Medication Compliance Among HIV-infected Men With Alcohol Use Disorder
A Phase 4 study testing oral naltrexone in people with HIV and Alcohol Use Disorder, run by Fred Hutchinson Cancer Center at 1 site in Peru.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- HIV, Alcohol Use Disorder
- What is being tested?
- oral naltrexone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 159 participants
- Where
- 1 sitePeru
- Study dates
- May 2014to Jun 2017
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Oral Naltrexone for Improved Medication Compliance Among HIV-infected Men With Alcohol Use Disorder
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.
- Conditions
- HIV, Alcohol Use Disorder
- Being tested
- oral naltrexone, Placebo pill
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oral naltrexoneDrug
Also called Nalerona
Placebo pillDrug
| Study group | Role | What they receive |
|---|---|---|
| Placebo pill | Placebo comparator | Daily oral placebo. Receives: Drug: Placebo pill |
| NTX | Active comparator | Daily oral naltrexone. Receives: Drug: oral naltrexone |
What is being measured
The primary outcome is the main question the study is designed to answer.
HIV Viral Load Suppression
The primary outcome will be the proportion with a VL<400 copies/mL at 6 months.
Measured: 6 months
Secondary outcomes (1)
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2011 (estimated)
- Study startMay 2014
- Primary completionJun 2016
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by Fred Hutchinson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 159 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fred Hutchinson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Yale University, Asociación Civil Impacta Salud y Educación, Peru
- Responsible party
- Principal investigator, Ann C Duerr, Fred Hutchinson Cancer Center
- Investigators
- Ann Duerr, MD, PhD, MPH, Principal investigator, Fred Hutchinson Cancer CenterFrederick Altice, MD, Study director, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01377168
- Sponsor's protocol ID
- XR-NTX ETOH
- Status last verified
- Jun 2017
- First submitted
- 17 Jun 2011
- Last updated
- 16 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Naltrexone for Improved Medication Compliance Among HIV-infected Men With Alcohol Use Disorder
- ClinicalTrials.gov ID
- NCT01377168
- Acronym / sponsor ID
- XR-NTX ETOH
- Conditions
- HIV, Alcohol Use Disorder
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 159 participants (actual)
- Lead sponsor
- Fred Hutchinson Cancer CenterUniversity, hospital or other
- Collaborators
- Yale University, Asociación Civil Impacta Salud y Educación, Peru
- Study start
- May 2014
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 21 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo pill | Placebo comparator | Drug: Placebo pillDaily oral placebo. |
| NTX | Active comparator | Drug: oral naltrexoneDaily oral naltrexone. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| oral naltrexoneAlso: Nalerona | Drug | NTX |
| Placebo pill | Drug | Placebo pill |
Primary outcome
HIV Viral Load Suppression
Time frame: 6 months
The primary outcome will be the proportion with a VL<400 copies/mL at 6 months.
1 secondary outcome
ART Compliance and Alcohol Use Behavior
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ann Duerr, MD, PhD, MPH principal investigator
Fred Hutchinson Cancer Center
Frederick Altice, MD study director
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing oral naltrexone in people with HIV and Alcohol Use Disorder, run by Fred Hutchinson Cancer Center at 1 site in Peru.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Peru. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HIV Viral Load Suppression (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2017.