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Adherence to HIV Therapy in Heroin Addicts
This study is currently recruiting participants.
Verified August 2016 by University of Pennsylvania
Sponsor:
University of Pennsylvania
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01101815
First received: April 8, 2010
Last updated: August 17, 2016
Last verified: August 2016
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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 ]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 ]
- Adherence to ART;
- Time to relapse;
- Number of days relapsed;
- Decline in CD4 counts;
- HIV risk behavior;
- Opioid positive urine tests;
- Number of days kept scheduled appointments;
- Psychiatric symptoms, other drug use, overall adjustment
| Estimated Enrollment: | 200 |
| Study Start Date: | June 2011 |
| Estimated Study Completion Date: | January 2017 |
| Estimated Primary Completion Date: | January 2017 (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 (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
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
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 | 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
| Responsible Party: | University of Pennsylvania |
| ClinicalTrials.gov Identifier: | NCT01101815 History of Changes |
| Other Study ID Numbers: |
DA026336 R01DA026336 ( U.S. NIH Grant/Contract ) |
| Study First Received: | April 8, 2010 |
| Last Updated: | August 17, 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 |
ClinicalTrials.gov processed this record on July 21, 2017