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

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
|
- 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
- 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

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

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