Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Adherence to HIV Therapy in Heroin Addicts: Oral vs XR-NTX

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01101815
Recruitment Status : Completed
First Posted : April 12, 2010
Last Update Posted : November 8, 2018
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
University of Pennsylvania

Brief Summary:
Substance use, particularly the compulsive behaviors associated with addiction, lead to unhealthy behaviors including non-adherence to antiretroviral therapy (ART) and treatment failure. High on the list of disorders leading to non-adherence is heroin addiction as a wide range of impulsive, high-risk behaviors accompanies it. The science of adherence would be improved by developing new methods to prevent relapse to heroin addiction, especially methods that can be used in settings that are not limited by the aims to test such a method using an implantable naltrexone formulation (IN) that is approved in Russia and blocks opioid effects for 3 months. The efficacy of the IN should be better than oral naltrexone (ON) because it does not depend on daily behavior to take a tablet and maintains a constant plasma level for months, which should result in sustained blockade, less relapse, and better ART adherence and treatment response.

Condition or disease Intervention/treatment Phase
HIV Substance Abuse HIV Infections Drug: Oral Naltrexone Drug: Naltrexone Implant Behavioral: Group Drug Counseling Manual Driven Phase 2

Detailed Description:

This is a double blind, double-dummy, placebo controlled, randomized trial of a 48-week course of implant naltrexone vs. oral naltrexone, each arm with drug counseling every two weeks, for 200 HIV+ patients who are in early remission from opioid dependence, and who are interested in relapse prevention treatment medication, and starting their first episode of antiretroviral therapy at the Botkin Infectious Disease Hospital in St. Petersburg or the Leningrad Regional AIDS Center. Early remission was chosen because relapse risk is the highest at this point, thus maximizing the chances for detecting a naltrexone effect. The first antiretroviral therapy treatment episode was chosen because it is feasible (relatively few opioid addicted Russians have been treated with antiretroviral therapy), and because the virus is less likely to have developed secondary resistance.

Participants will be recruited from the AIDS and addiction programs and who meet study admission criteria will be stratified within each site according to baseline viral load (>100,000 copies/<100,000 copies) and cluster of differentiation 4 (CD4) count (>50/<50 copies). Participants will be randomized to a treatment condition, receive a naloxone challenge, and if pass be prescribed oral naltrexone or oral placebo and implant/implant placebo), and given a schedule for addiction counseling and HIV treatment appointments. A 2-week supply of oral medication will be provided at each bi-weekly counseling session, and will be re-implanted at weeks 12, 24, and 36. Only the research pharmacist will know the group assignments, however the blind can be broken in case of emergency.

The primary outcome measure will be to compare implanted naltrexone versus oral naltrexone on ability to achieve a viral load of <400 copies at weeks 24 and 48.

Secondary outcomes are to compare the efficacy of the two addiction treatments; to study the adherence to antiretroviral therapy; to evaluate time to relapse and the number of days to relapsed; to evaluate decline in CD4 counts; to evaluate HIV risk behavior; to evaluate opioid positive urine tests; and to evaluate the number of days that patients will keep their scheduled appointments. The Investigator will also monitor psychiatric symptoms, other drug use, and overall adjustment.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Adherence to HIV Therapy in Heroin Addicts: Oral vs. Extended Release Naltrexone
Actual Study Start Date : June 2010
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Active Comparator: Oral Naltrexone + ART
Naltrexone (oral). 50 mg maintenance daily for 48 weeks, plus group drug counseling manual driven, N= 100
Drug: Oral Naltrexone
50 mg/day-oral
Other Name: Revia

Behavioral: Group Drug Counseling Manual Driven
Given to both groups biweekly, weeks 2 - 48. Counseling will consist of three components: 1) giving advice, support and clinical management aimed to maintain abstinence; 2) adherence enhancement to encourage keeping appointments, taking ART medications as prescribed and getting treatment for associated problems; and 3) reviewing behaviors that are likely to spread HIV and other infectious diseases, and counseling on how to stop them.

Active Comparator: Naltrexone Implant + ART
Naltrexone Implant + ART. Monthly maintenance for 48 Weeks plus, group drug counseling manual driven, N=100
Drug: Naltrexone Implant
monthly-implant
Other Name: Prodetoxon

Behavioral: Group Drug Counseling Manual Driven
Given to both groups biweekly, weeks 2 - 48. Counseling will consist of three components: 1) giving advice, support and clinical management aimed to maintain abstinence; 2) adherence enhancement to encourage keeping appointments, taking ART medications as prescribed and getting treatment for associated problems; and 3) reviewing behaviors that are likely to spread HIV and other infectious diseases, and counseling on how to stop them.




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 [ 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



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • must be HIV+ men/women starting their first episode of ART or starting a new ART treatment episode and was prescribed medications that suppressed the virus to <400 copies during their last treatment
  • understand that they will be prescribed ART medications that they have never received and to which their virus is likely to be susceptible
  • viral loads of 1,000 copies or more
  • meet the Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition (DSM-IV) criteria for opioid dependence in early remission
  • have a negative opiate urine toxicology and alcohol breath test
  • show no evidence of physiologic dependence on physical exam and following a naltrexone challenge
  • have a stable address in the St. Petersburg or Leningrad Region of Russia area
  • have a valid telephone number where subject can be reached
  • have a negative pregnancy test and use adequate contraception
  • have the 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

Exclusion Criteria:

  • not be currently psychotic as determined by a psychiatric examination (i.e.; schizophrenia, paranoid disorder, mania)
  • not have current suicidal or homicidal ideation requiring immediate attention as determined at baseline assessment
  • not have an uncontrolled seizure disorder
  • not have cognitive impairment with an inability to read and understand the consent
  • not have significant laboratory abnormality such as >2 grade anemia
  • not have hepatic transaminase levels >5 times the upper limit of normal
  • not have serum creatinine >1.5 times the upper limit of normal
  • not have pending legal charges with impending incarceration
  • not be concurrently participating in another treatment study
  • not currently taking naltrexone

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


Locations
Layout table for location information
Russian Federation
Botkin Infectious Disease Hospital
Leningrad Region, Russian Federation, 188661
Botkin Infectious Disease Hospital
Leningrad, Russian Federation, 197376
Sponsors and Collaborators
University of Pennsylvania
National Institute on Drug Abuse (NIDA)
Investigators
Layout table for investigator information
Principal Investigator: George E Woody University of Pennsylvania
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01101815    
Obsolete Identifiers: NCT02046252
Other Study ID Numbers: R01DA-0263360-01
R01DA026336 ( U.S. NIH Grant/Contract )
First Posted: April 12, 2010    Key Record Dates
Last Update Posted: November 8, 2018
Last Verified: February 2018
Keywords provided by University of Pennsylvania:
Viral Loads
Naltrexone
HIV Risk
Substance Abuse
Additional relevant MeSH terms:
Layout table for MeSH terms
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Naltrexone
Alcohol Deterrents
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents