Trial record 2 of 24 for:    " March 31, 2010":" April 30, 2010"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]

Adherence to HIV Therapy in Heroin Addicts

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2012 by University of Pennsylvania.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Information provided by:
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01101815
First received: April 8, 2010
Last updated: January 10, 2012
Last verified: January 2012
  Purpose

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 Intervention Phase
HIV
Substance Abuse
HIV Infections
Drug: Oral Naltrexone (ON)
Drug: Implantable Naltrexone (IN)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Adherence to HIV Therapy in Heroin Addicts: Oral vs. Extended Release Naltrexone

Resource links provided by NLM:


Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • Adherence Oral (ON) vs Implant (IN) naltrexone [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
    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:
  • Compare efficacy of the two treatments on: [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 200
Study Start Date: July 2010
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 Not yet recruiting
Leningrad Region, Russian Federation, 188661
Principal Investigator: Evgeny Krupitsky, MD         
Leningrad Region AIDS Center Not yet recruiting
St. Petersburg, Russian Federation, 197376
Principal Investigator: Evgeny Krupitsky, MD         
Sponsors and Collaborators
University of Pennsylvania
  More Information

No publications provided

Responsible Party: Pam Caudill, Associate Vice Provost of Research Services, Trustees of the University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01101815     History of Changes
Other Study ID Numbers: DA026336, R01DA026336
Study First Received: April 8, 2010
Last Updated: January 10, 2012
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Naltrexone
Narcotic Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 18, 2014