Adherence to HIV Therapy in Heroin Addicts: Oral vs. Extended Release Naltrexone
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ClinicalTrials.gov Identifier: NCT02046252 |
Recruitment Status
:
Completed
First Posted
: January 27, 2014
Last Update Posted
: February 26, 2018
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Human Immunodeficiency Virus | Drug: Oral naltrexone Drug: Naltrexone implant | Phase 2 |
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 : | Interventional (Clinical Trial) |
Actual Enrollment : | 200 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Adherence to HIV Therapy in Heroin Addicts: Oral vs. Extended Release Naltrexone |
Actual Study Start Date : | June 2010 |
Actual Primary Completion Date : | December 2016 |
Actual Study Completion Date : | December 2016 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Naltrexone Implant + ART
Naltrexone implant maintenance 48 weeks plus psychotherapy N=100
|
Drug: Naltrexone implant
monthly
Other Name: Prodetoxon implant
|
Active Comparator: ON Oral Naltrexone
ON (oral) naltrexone maintenance 48 weeks plus psychotherapy N=100
|
Drug: Oral naltrexone
50 mg/day
Other Name: Revia
|
- Viral Load [ Time Frame: 1 year ]equal to or less than 400 copies
- Adherence to ART [ Time Frame: 1 year ]Medication Event Monitoring System (MEMS) cap measured at prescribed dosing per medication

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02046252
Russian Federation | |
Botkin Infectious Disease Hospital | |
Leningrad, Russian Federation |
Principal Investigator: | George E Woody, MD | University of Pennsylvania |
Responsible Party: | University of Pennsylvania |
ClinicalTrials.gov Identifier: | NCT02046252 History of Changes |
Other Study ID Numbers: |
R01-DA-0263360-01 5R01DA026336 ( U.S. NIH Grant/Contract ) |
First Posted: | January 27, 2014 Key Record Dates |
Last Update Posted: | February 26, 2018 |
Last Verified: | February 2018 |
Additional relevant MeSH terms:
Immunologic Deficiency Syndromes Acquired Immunodeficiency Syndrome HIV Infections Immune System Diseases Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Slow Virus Diseases |
Naltrexone Heroin Narcotic Antagonists Physiological Effects of Drugs Sensory System Agents Peripheral Nervous System Agents Analgesics, Opioid Narcotics Central Nervous System Depressants Analgesics |