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Adherence to HIV Therapy in Heroin Addicts

This study is currently recruiting participants.

See

Contacts and Locations

Verified August 2016 by University of Pennsylvania

Sponsor:

ClinicalTrials.gov Identifier:

NCT01101815

First Posted: April 12, 2010

Last Update Posted: August 19, 2016

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.

Collaborator:

National Institute on Drug Abuse (NIDA)

Information provided by (Responsible Party):

University of Pennsylvania

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: None (Open Label) Primary Purpose: Treatment
Official Title:	Adherence to HIV Therapy in Heroin Addicts: Oral vs. Extended Release Naltrexone

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS

Drug Information available for: Naltrexone Naltrexone hydrochloride

U.S. FDA Resources

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 ]
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:	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

Information from the National Library of Medicine

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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

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


Responsible Party:	University of Pennsylvania
ClinicalTrials.gov Identifier:	NCT01101815 History of Changes
Other Study ID Numbers:	DA026336 R01DA026336 ( U.S. NIH Grant/Contract )
First Submitted:	April 8, 2010
First Posted:	April 12, 2010
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

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