Adherence to HIV Therapy in Heroin Addicts: Oral vs XR-NTX
2 other identifiers
interventional
200
1 country
2
Brief Summary
Substance use, particularly the compulsive behaviors associated with addiction, lead to unhealthy behaviors including non-adherence to antiretroviral therapy (ART) and treatment failure. High on the list of disorders leading to non-adherence is heroin addiction as a wide range of impulsive, high-risk behaviors accompanies it. The science of adherence would be improved by developing new methods to prevent relapse to heroin addiction, especially methods that can be used in settings that are not limited by the aims to test such a method using an implantable naltrexone formulation (IN) that is approved in Russia and blocks opioid effects for 3 months. The efficacy of the IN should be better than oral naltrexone (ON) because it does not depend on daily behavior to take a tablet and maintains a constant plasma level for months, which should result in sustained blockade, less relapse, and better ART adherence and treatment response.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 hiv
Started Jun 2010
Longer than P75 for phase_2 hiv
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 8, 2010
CompletedFirst Posted
Study publicly available on registry
April 12, 2010
CompletedStudy Start
First participant enrolled
June 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedNovember 8, 2018
February 1, 2018
6.5 years
April 8, 2010
November 6, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Adherence Oral (ON) vs Implant (IN) naltrexone
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 Outcomes (1)
Compare efficacy of the two treatments
48 weeks
Study Arms (2)
Oral Naltrexone + ART
ACTIVE COMPARATORNaltrexone (oral). 50 mg maintenance daily for 48 weeks, plus group drug counseling manual driven, N= 100
Naltrexone Implant + ART
ACTIVE COMPARATORNaltrexone Implant + ART. Monthly maintenance for 48 Weeks plus, group drug counseling manual driven, N=100
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Botkin Infectious Disease Hospital
Saint Petersburg, Russian Federation, 197376, Russia
Botkin Infectious Disease Hospital
Leningrad Region, 188661, Russia
Related Publications (2)
Kornor H, Lobmaier PPK, Kunoe N. Sustained-release naltrexone for opioid dependence. Cochrane Database Syst Rev. 2025 May 9;5(5):CD006140. doi: 10.1002/14651858.CD006140.pub3.
PMID: 40342086DERIVEDKrupitsky E, Blokhina E, Zvartau E, Verbitskaya E, Lioznov D, Yaroslavtseva T, Palatkin V, Vetrova M, Bushara N, Burakov A, Masalov D, Mamontova O, Langleben D, Poole S, Gross R, Woody G. Slow-release naltrexone implant versus oral naltrexone for improving treatment outcomes in people with HIV who are addicted to opioids: a double-blind, placebo-controlled, randomised trial. Lancet HIV. 2019 Apr;6(4):e221-e229. doi: 10.1016/S2352-3018(18)30362-X. Epub 2019 Mar 14.
PMID: 30880163DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
George E Woody
University of Pennsylvania
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 8, 2010
First Posted
April 12, 2010
Study Start
June 1, 2010
Primary Completion
December 1, 2016
Study Completion
December 1, 2016
Last Updated
November 8, 2018
Record last verified: 2018-02