- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01101815
Adherence to HIV Therapy in Heroin Addicts: Oral vs XR-NTX
Adherence to HIV Therapy in Heroin Addicts: Oral vs. Extended Release Naltrexone
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This is a double blind, double-dummy, placebo controlled, randomized trial of a 48-week course of implant naltrexone vs. oral naltrexone, each arm with drug counseling every two weeks, for 200 HIV+ patients who are in early remission from opioid dependence, and who are interested in relapse prevention treatment medication, and starting their first episode of antiretroviral therapy at the Botkin Infectious Disease Hospital in St. Petersburg or the Leningrad Regional AIDS Center. Early remission was chosen because relapse risk is the highest at this point, thus maximizing the chances for detecting a naltrexone effect. The first antiretroviral therapy treatment episode was chosen because it is feasible (relatively few opioid addicted Russians have been treated with antiretroviral therapy), and because the virus is less likely to have developed secondary resistance.
Participants will be recruited from the AIDS and addiction programs and who meet study admission criteria will be stratified within each site according to baseline viral load (>100,000 copies/<100,000 copies) and cluster of differentiation 4 (CD4) count (>50/<50 copies). Participants will be randomized to a treatment condition, receive a naloxone challenge, and if pass be prescribed oral naltrexone or oral placebo and implant/implant placebo), and given a schedule for addiction counseling and HIV treatment appointments. A 2-week supply of oral medication will be provided at each bi-weekly counseling session, and will be re-implanted at weeks 12, 24, and 36. Only the research pharmacist will know the group assignments, however the blind can be broken in case of emergency.
The primary outcome measure will be to compare implanted naltrexone versus oral naltrexone on ability to achieve a viral load of <400 copies at weeks 24 and 48.
Secondary outcomes are to compare the efficacy of the two addiction treatments; to study the adherence to antiretroviral therapy; to evaluate time to relapse and the number of days to relapsed; to evaluate decline in CD4 counts; to evaluate HIV risk behavior; to evaluate opioid positive urine tests; and to evaluate the number of days that patients will keep their scheduled appointments. The Investigator will also monitor psychiatric symptoms, other drug use, and overall adjustment.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
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Leningrad, Russian Federation, 197376
- Botkin Infectious Disease Hospital
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Leningrad Region, Russian Federation, 188661
- Botkin Infectious Disease Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- must be HIV+ men/women starting their first episode of ART or starting a new ART treatment episode and was prescribed medications that suppressed the virus to <400 copies during their last treatment
- understand that they will be prescribed ART medications that they have never received and to which their virus is likely to be susceptible
- viral loads of 1,000 copies or more
- meet the Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition (DSM-IV) criteria for opioid dependence in early remission
- have a negative opiate urine toxicology and alcohol breath test
- show no evidence of physiologic dependence on physical exam and following a naltrexone challenge
- have a stable address in the St. Petersburg or Leningrad Region of Russia area
- have a valid telephone number where subject can be reached
- have a negative pregnancy test and use adequate contraception
- have the ability to give informed consent as judged by ability to read the consent and correctly answer 9 of 10 questions about the study on a quiz that will be administered after discussing the study and reading the consent
Exclusion Criteria:
- not be currently psychotic as determined by a psychiatric examination (i.e.; schizophrenia, paranoid disorder, mania)
- not have current suicidal or homicidal ideation requiring immediate attention as determined at baseline assessment
- not have an uncontrolled seizure disorder
- not have cognitive impairment with an inability to read and understand the consent
- not have significant laboratory abnormality such as >2 grade anemia
- not have hepatic transaminase levels >5 times the upper limit of normal
- not have serum creatinine >1.5 times the upper limit of normal
- not have pending legal charges with impending incarceration
- not be concurrently participating in another treatment study
- not currently taking naltrexone
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Oral Naltrexone + ART
Naltrexone (oral).
50 mg maintenance daily for 48 weeks, plus group drug counseling manual driven, N= 100
|
50 mg/day-oral
Other Names:
Given to both groups biweekly, weeks 2 - 48.
Counseling will consist of three components: 1) giving advice, support and clinical management aimed to maintain abstinence; 2) adherence enhancement to encourage keeping appointments, taking ART medications as prescribed and getting treatment for associated problems; and 3) reviewing behaviors that are likely to spread HIV and other infectious diseases, and counseling on how to stop them.
|
ACTIVE_COMPARATOR: Naltrexone Implant + ART
Naltrexone Implant + ART.
Monthly maintenance for 48 Weeks plus, group drug counseling manual driven, N=100
|
Given to both groups biweekly, weeks 2 - 48.
Counseling will consist of three components: 1) giving advice, support and clinical management aimed to maintain abstinence; 2) adherence enhancement to encourage keeping appointments, taking ART medications as prescribed and getting treatment for associated problems; and 3) reviewing behaviors that are likely to spread HIV and other infectious diseases, and counseling on how to stop them.
monthly-implant
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adherence Oral (ON) vs Implant (IN) naltrexone
Time Frame: 48 weeks
|
The primary aim is to compare the ability IN vs ON to achieve a viral load of <400 copies at weeks 24 and 48
|
48 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Compare efficacy of the two treatments
Time Frame: 48 weeks
|
|
48 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: George E Woody, University of Pennsylvania
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- R01DA-0263360-01
- R01DA026336 (NIH)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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