Adherence to HIV Therapy in Heroin Addicts

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01101815
Recruitment Status : Recruiting
First Posted : April 12, 2010
Last Update Posted : August 19, 2016
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
University of Pennsylvania

April 8, 2010
April 12, 2010
August 19, 2016
June 2011
January 2017   (Final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01101815 on Archive Site
Compare efficacy of the two treatments on: [ Time Frame: 48 weeks ]
  1. Adherence to ART;
  2. Time to relapse;
  3. Number of days relapsed;
  4. Decline in CD4 counts;
  5. HIV risk behavior;
  6. Opioid positive urine tests;
  7. Number of days kept scheduled appointments;
  8. Psychiatric symptoms, other drug use, overall adjustment
Same as current
Not Provided
Not Provided
Adherence to HIV Therapy in Heroin Addicts
Adherence to HIV Therapy in Heroin Addicts: Oral vs. Extended Release Naltrexone
This study will obtain pilot data on the impact oral naltrexone 50 mg/day vs. a sustained-release naltrexone implant on response to antiretroviral therapy (ART) in opioid addicted patients beginning ART in St. Petersburg, Russia.
The study will randomize, in a 1:1 ratio, 260 recently detoxified opioid addicts beginning ART to a 48-week course of biweekly drug counseling with either oral naltrexone 50 mg/day + placebo naltrexone implant, or placebo tablet + naltrexone implant. Approximate balanced randomization will be achieved by using an urn randomization design within each set of sites based in two baseline characteristics: (1) viral load >100,000 copies/<100,000 copies, and (2) CDF count >50/>50 copies. The primary outcome will be the response to ART as measured by reduction in viral load at 24 and 48 weeks.
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • HIV
  • Substance Abuse
  • HIV Infections
  • Drug: Oral Naltrexone (ON)
    48 weeks of oral naltrexone as compared to 48 weeks of implantable naltrexone
  • Drug: Implantable Naltrexone (IN)
    48 weeks of implantable naltrexone as compared with 48 weeks of oral naltrexone
  • Active Comparator: Oral Naltrexone (ON)
    Oral naltrexone for 48 weeks versus implantable naltrexone for 48 weeks
    Intervention: Drug: Oral Naltrexone (ON)
  • Active Comparator: Implantable Naltrexone (IN)
    48 Weeks of implantable naltrexone as compared with 48 weeks of oral naltrexone
    Intervention: Drug: Implantable Naltrexone (IN)
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
January 2017
January 2017   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • HIV+ men or women with no prior ART
  • Age 18 and above
  • CD4+ lymphocyte counts <350 cells/mm3
  • Viral load of 1,000 copies or more
  • Meet DSM-IV criteria for Opioid Dependence in Early Remission
  • Negative opiate urine toxicology and alcohol breath test
  • No evidence of physiologic dependence on physical examination and After naloxone challenge
  • Stable address in St. Petersburg or the Leningrad Region
  • Telephone number where subjects can be reached (most patients in prior Studies have mobile phones and all live with friends or relatives)
  • Negative pregnancy test & use adequate contraception if childbearing age
  • 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 (patients will be given three opportunities to retake and pass the quiz if they fail the first time)

Exclusion Criteria:

  • Currently psychotic as determined by psychiatric examination (schizophrenia, Paranoid disorder, mania)
  • Suicidal or homicidal ideation requiring immediate attention as determined at Baseline assessment
  • Uncontrolled seizure disorder;
  • Cognitive impairment with inability to read and understand the consent
  • Significant laboratory abnormality such as >2 grade anemia, hepatic transaminase Levels >3 times upper limit of normal, serum creatinine >1.5 times UNL
  • Legal charges with impending incarceration
  • Concurrent participation in another treatment study
  • Currently taking naltrexone.
Sexes Eligible for Study: All
18 Years to 64 Years   (Adult)
Contact: Evgeny Krupitsky, MD 78122969905
Contact: Edwin Zvartau, MD 7184997023
Russian Federation
R01DA026336 ( U.S. NIH Grant/Contract )
Not Provided
Not Provided
University of Pennsylvania
University of Pennsylvania
National Institute on Drug Abuse (NIDA)
Not Provided
University of Pennsylvania
August 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP