HIV InfectionPhase 4NCT00854230
Pharmacotherapy for HIV Infected Patients With Alcohol Problems
A Phase 4 study testing Naltrexone in people with HIV Infection and Heavy Alcoholic Consumption, run by VA Connecticut Healthcare System.
Trial 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 (25-100mg)and placebo. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infection, Heavy Alcoholic Consumption, HIV Infections
- What is being tested?
- Naltrexone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jan 2009to Jan 2010
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be HIV-positive.
- Report heavy drinking 4 or more times in the past 4 weeks. Heavy drinking is defined as 4 or more drinks for women and 5 or more drinks for men on any occasion.
- Not be abstinent from alcohol for greater than 30 days.
- Be at least 18 years old.
- Be able to understand English and provide informed consent
Who cannot join
- Be psychotic or severely psychiatrically disabled.
- Have medical conditions that would preclude completing or be of harm during the course of the study.
- Have laboratory or clinical evidence of significant liver dysfunction (alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than 3 times the upper limit of the normal range) or cirrhosis.
- Have a known contraindication to naltrexone therapy (e.g. taking opioid medication for pain).
- Be pregnant, nursing or unable to use an effective method of birth control (women).
- Subjects who are taking or use narcotics will not be included because naltrexone will precipitate withdrawal.
About this study
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 (25-100mg)and 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.
- Conditions
- HIV Infection, Heavy Alcoholic Consumption, HIV Infections
- Being tested
- Naltrexone
- Keywords
- HIV, alcohol, naltrexone, Treatment Experienced
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NaltrexoneDrug
Also called Revia
Naltrexone dose 25-100mg
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Naltrexone Receives: Drug: Naltrexone |
| 2 | Placebo comparator | Not described Receives: Drug: Naltrexone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of heavy drinking
Measured: 12 weeks
Secondary outcomes (3)
HIV biological markers
Measured: 12 weeks
Sexual risk behavior
Measured: 12 weeks
Tolerability and retention in alcohol treatment
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2009 (estimated)
- Study startJan 2009
- Primary completionJan 2010
- Study completionJan 2010
Why it stopped: We expanded to a bigger, multi-site study \& decided to close this study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionStudies of the same condition, open and under way.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Connecticut Healthcare System
- Sponsor type
- US federal agency
- Collaborators
- Yale University
- Responsible party
- Sponsor
- Investigators
- David A Fiellin, Md, Principal investigator, Yale UniversityAmy Justice, MD, PhD, Principal investigator, Yale University, West Haven VA hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00854230
- Sponsor's protocol ID
- AJ0007
- Other IDs
- 0901004647
- Status last verified
- Mar 2012
- First submitted
- 2 Mar 2009
- Last updated
- 28 Mar 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacotherapy for HIV Infected Patients With Alcohol Problems
- ClinicalTrials.gov ID
- NCT00854230
- Acronym / sponsor ID
- AJ0007
- Conditions
- HIV Infection, Heavy Alcoholic Consumption, HIV Infections
- Keywords
- HIV, alcohol, naltrexone, Treatment Experienced
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: We expanded to a bigger, multi-site study \& decided to close this study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- VA Connecticut Healthcare SystemUS federal agency
- Collaborators
- Yale University
- Study start
- Jan 2009
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 3 Mar 2009 (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 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 (25-100mg)and 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: NaltrexoneNaltrexone |
| 2 | Placebo comparator | Drug: Naltrexone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Be HIV-positive.
- Report heavy drinking 4 or more times in the past 4 weeks. Heavy drinking is defined as 4 or more drinks for women and 5 or more drinks for men on any occasion.
- Not be abstinent from alcohol for greater than 30 days.
- Be at least 18 years old.
- Be able to understand English and provide informed consent
Key exclusion criteria (6 listed)
- Be psychotic or severely psychiatrically disabled.
- Have medical conditions that would preclude completing or be of harm during the course of the study.
- Have laboratory or clinical evidence of significant liver dysfunction (alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than 3 times the upper limit of the normal range) or cirrhosis.
- Have a known contraindication to naltrexone therapy (e.g. taking opioid medication for pain).
- Be pregnant, nursing or unable to use an effective method of birth control (women).
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 |
|---|---|---|
| NaltrexoneAlso: ReviaNaltrexone dose 25-100mg | Drug | 1, 2 |
Primary outcome
Frequency of heavy drinking
Time frame: 12 weeks
3 secondary outcomes
HIV biological markers
Time frame: 12 weeks
Sexual risk behavior
Time frame: 12 weeks
Tolerability and retention in alcohol treatment
Time frame: 12 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2012.
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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.
David A Fiellin, Md principal investigator
Yale University
Amy Justice, MD, PhD principal investigator
Yale University, West Haven VA hospital
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Naltrexone in people with HIV Infection and Heavy Alcoholic Consumption, run by VA Connecticut Healthcare System.
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 6 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: withdrawn, as of the sponsor's last update on 28 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Frequency of heavy drinking (time frame: 12 weeks). 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 28 Mar 2012.