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Adherence to HIV Therapy in Heroin Addicts

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ClinicalTrials.gov Identifier: NCT01101815
Recruitment Status : Recruiting
First Posted : April 12, 2010
Last Update Posted : August 19, 2016
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
University of Pennsylvania

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
HIV Substance Abuse HIV Infections Drug: Oral Naltrexone (ON) Drug: Implantable Naltrexone (IN) Phase 3

Detailed Description:
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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Adherence to HIV Therapy in Heroin Addicts: Oral vs. Extended Release Naltrexone
Study Start Date : June 2011
Estimated Primary Completion Date : January 2017
Estimated Study Completion Date : January 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Oral Naltrexone (ON)
Oral naltrexone for 48 weeks versus implantable naltrexone for 48 weeks
 Drug: Oral Naltrexone (ON)
48 weeks of oral naltrexone as compared to 48 weeks of implantable naltrexone
Active Comparator: Implantable Naltrexone (IN)
48 Weeks of implantable naltrexone as compared with 48 weeks of oral naltrexone
 Drug: Implantable Naltrexone (IN)
48 weeks of implantable naltrexone as compared with 48 weeks of oral naltrexone


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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): NCT01101815


Contacts
Contact: Evgeny Krupitsky, MD 78122969905 kru@ek3506.edu
Contact: Edwin Zvartau, MD 7184997023 zvartau@spmu.rssi.ru

Locations
Russian Federation
Leningrad Region Addiction Treatment Recruiting
Leningrad Region, Russian Federation, 188661
Principal Investigator: Evgeny Krupitsky, MD         
Leningrad Region AIDS Center Recruiting
St. Petersburg, Russian Federation, 197376
Principal Investigator: Evgeny Krupitsky, MD         
Sponsors and Collaborators
University of Pennsylvania
National Institute on Drug Abuse (NIDA)
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01101815     History of Changes
Other Study ID Numbers: DA026336
R01DA026336 ( U.S. NIH Grant/Contract )
First Posted: April 12, 2010    Key Record Dates
Last Update Posted: August 19, 2016
Last Verified: August 2016

Keywords provided by University of Pennsylvania:
Viral Loads
Naltrexone
HIV Risk
Substance Abuse

Additional relevant MeSH terms:
HIV Infections
Substance-Related Disorders
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Chemically-Induced Disorders
 Mental Disorders
Naltrexone
Heroin
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Analgesics