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Trial record 2 of 3132 for:    HIV Infections | NIH

Drug Treatment Combined With Drug and Risk Reduction Counseling to Prevent of HIV Infection and Death Among Injection Drug Users

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ClinicalTrials.gov Identifier: NCT00270257
Recruitment Status : Terminated (DSMB halted the study due to futility as a result of lower than anticipated HIV incidence rates)
First Posted : December 26, 2005
Results First Posted : December 8, 2016
Last Update Posted : February 2, 2017
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

Tracking Information
First Submitted Date  ICMJE December 22, 2005
First Posted Date  ICMJE December 26, 2005
Results First Submitted Date  ICMJE November 5, 2015
Results First Posted Date  ICMJE December 8, 2016
Last Update Posted Date February 2, 2017
Study Start Date  ICMJE May 2008
Actual Primary Completion Date July 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 14, 2016)
Evidence of HIV-1 Infection or Death for Visits up to 104 Weeks [ Time Frame: For visits up to week 104 ]
The primary endpoint for the study was cumulative HIV infection or death after a second year of follow-up (i.e. at week 104), one year after completion of the treatment phase, designed to test a durable intervention effect.
Original Primary Outcome Measures  ICMJE
 (submitted: December 22, 2005)
HIV-1 infection at Week 104
Change History Complete list of historical versions of study NCT00270257 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 14, 2016)
  • Number of Participants With Urinalysis Results Positive for Opiates [ Time Frame: Measured through Week 104 ]
    Urine drug screen were assessed monthly and semiannually.
  • Self-report of Continued Injection Opiate Use in the Last 30 Days [ Time Frame: Measured through Week 104 ]
    All participants completed interviewer-administered assessments of injection and non-injection drug use at baseline and at semi-annual visits.
  • Number of Participants Reported Using Injection Equipment (Needles, Syringes, Cookers, Cottons, and Rinse Water) in the Prior 6 Months [ Time Frame: Measured through Week 104 ]
  • Self-reported Number of Injections in the Last Month [ Time Frame: Measured through Week 104 ]
  • Incident Hepatitis C Infections for Thailand and China [ Time Frame: Measured through week 156 in Thailand and 104 weeks in China ]
    HCV antibody using two different HCV EIA assays (Ortho HCV antibody version 3.0 and Wantai HCV antibody assay) at baseline and between 26-156 weeks later. If both HCV EIA antibody assays were nonreactive, then the participant was considered not to be HCV infected. If either assay was reactive, then the Ortho HCV assay was repeated in duplicate. If two of 3 Ortho HCV assays were reactive, then the participant was considered to be HCV infected. Samples that were repeatedly reactive for HCV antibody at a follow-up visit were tested for HCV RNA by the Roche COBAS® AmpliPrep/COBAS® TaqMan® HCV assay. Not all participants had follow-up testing performed in China due to early closure of the study by the Data Safety Monitoring Board on account of futility due to a low HIV incidence (the primary study endpoint). Analysis was done separately for both countries
  • Incident Hepatitis B Infections [ Time Frame: Measured through week 52 ]
    Serum samples were tested at baseline and between 26-52 weeks later for Hepatitis B surface antigen (HBsAg) using a commercial enzyme immunoassay (EIA) (Abbott Murex HBsAg version 3.0). If the HBsAg test was initially non-reactive, then the participant was considered to be negative for HBsAg. If the HBsAg test was initially reactive, then it was repeated in duplicate. If at least two of 3 tests were reactive, then the participant was considered to be positive for HBsAg.
Original Secondary Outcome Measures  ICMJE
 (submitted: December 22, 2005)
  • HIV-1 infection every 6 months at scheduled study follow-up visits
  • mortality
  • Continued opiate use as measured by self-report and urinalysis
  • Self-reported frequency of injection
  • Self-reported frequency of injection with previously used injection equipment (needles, syringes, cookers, cottons, and rinse water)
  • Self-reported frequency of unprotected sex or sex sold/traded for drugs
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Drug Treatment Combined With Drug and Risk Reduction Counseling to Prevent of HIV Infection and Death Among Injection Drug Users
Official Title  ICMJE A Phase III Randomized Controlled Trial to Evaluate the Efficacy of Drug Treatment in Prevention of HIV Infection and Death Among Opiate Dependent Injectors
Brief Summary Drug abuse and HIV/AIDS are serious global health problems. Injection drug use is currently the major mode of transmission of HIV in many countries. The purpose of this study is to determine the effectiveness of drug and risk reduction counseling combined with either substitution drug treatment with buprenorphine/naloxone (BUP/NX) or short-term detoxification with BUP/NX in preventing HIV transmission among injection drug users. Participants will be recruited for this study in China and Thailand.
Detailed Description

Effective HIV prevention among injection drug users (IDUs) requires educating the at-risk population about HIV transmission and risky behavior, and providing the means for behavior change. Current treatment for opiate dependence focuses on reducing the frequency of drug use. BUP/NX is a combination pill currently used to treat opiate-dependent individuals. This trial will evaluate the effectiveness of two therapies in preventing HIV transmission among IDUs. Drug and risk reduction counseling combined with either long term medication assisted treatment (LT-MAT) with BUP/NX or short term medication assisted treatment (ST-MAT) with BUP/NX will be compared in preventing the transmission of HIV among opiate-dependent individuals.

This study will last 4.5 years. Participants in this study will be randomly assigned to one of two treatment arms. Group 1 will receive LT-MAT with BUP/NX. Group 2 will receive ST-MAT with BUP/NX. An initial 4-week safety and feasibility phase will involve the first 50 participants at each site and will last approximately 30 weeks. Study visits will occur every week and will include a physical exam and blood and urine collection.

The main treatment phase of the study will last 52 weeks. Participants in Group 1 will receive BUP/NX under the tongue, at first daily and then three times a week for 52 weeks. Participants assigned to Group 1 will take part in a BUP/NX reduction phase, which will occur between Weeks 47 and 52. Participants in Group 2 will receive short-term BUP/NX; dosage and length of treatment will be determined by the investigator. Participants assigned to Group 2 will receive BUP/NX for a maximum of 18 days; detoxification may be repeated at Week 26 if the participant is still injecting opiates. After Week 4 of the safety phase and Weeks 26 and 52 of the overall study, participants will complete an intervention acceptability assessment.

In addition, participants in both groups will attend drug and risk reduction counseling weekly. After the first 12 weeks, participants will return every 4 weeks for 10 more counseling sessions. HIV testing, hepatitis C testing, risk assessment, and urine tests for opiates will occur at screening and at Weeks 26, 52, 78, 104, 130 and 156. Plasma from blood samples will be stored at each of these visits. Hepatitis B testing will occur at Week 26. Participants in China will attend study visits through approximately Week 104, and participants in Thailand will attend study visits through approximately Week 156.

Participants in China who have been incarcerated may participate in an optional substudy, which is examining the withdrawal effects from BUP/NX after incarceration. Participants who agree to take part in the substudy will attend one study visit and will complete a questionnaire.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • HIV Infections
  • Opioid-Related Disorders
Intervention  ICMJE Drug: Buprenorphine/Naloxone
Oral tablet
Other Name: BUP/NX
Study Arms  ICMJE
  • Experimental: Long term medication assisted treatment (LT-MAT)
    Participants will receive BUP/NX under the tongue daily for a maximum of three weeks(until dose stabilization) and then three times a week for 52 weeks in addition to weekly drug and risk reduction counseling for 12 weeks, and then every 4 weeks through Week 52
    Intervention: Drug: Buprenorphine/Naloxone
  • Experimental: Short term medication assisted treatment (ST-MAT)
    Participants will receive short-term BUP/NX; dosage and length of treatment will be determined by the investigator.Additionally, participants will undergo weekly drug and risk reduction counseling for 12 weeks, and then every 4 weeks through Week 52.
    Intervention: Drug: Buprenorphine/Naloxone
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: October 14, 2016)
1251
Original Enrollment  ICMJE
 (submitted: December 22, 2005)
1460
Actual Study Completion Date  ICMJE July 2012
Actual Primary Completion Date July 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • HIV-uninfected within 28 days of enrollment
  • Meets DSM-IV criteria for opiate dependence
  • Positive urine test for opiates
  • Injected opiates at least 12 times in the 28 days prior to enrollment, according to self-report
  • Willing to use acceptable forms of contraception for the first 12 months of the study
  • Able to provide contact information and willing to be contacted by study staff as necessary
  • Available for study visits for at least 2 years

Exclusion Criteria:

  • Current treatment with methadone, morphine, levo-alpha-acetyl-methadol (LAAM), naltrexone, or nalmefene
  • Currently enrolled in another HIV prevention or drug use intervention study
  • Known sensitivity to buprenorphine or naloxone
  • Requires immediate medical attention for dependence on alcohol, benzodiazepines, or other substances. People who are dependent on tobacco are not excluded.
  • Currently injecting drugs of abuse other than opiates, more than twice in the last 28 days, according to self-report
  • Psychological disturbance or cognitive impairment that may interfere with the study
  • Acute or chronic kidney failure
  • Certain abnormal laboratory values
  • Any other medical or psychiatric condition that, in the opinion of the investigator, would make participation in this study unsafe
  • Pregnant or breastfeeding

Inclusion Criteria for Substudy:

  • Current or former participant in HPTN 058 study in Xinjiang who was actively in the long-term treatment arm on stable maintenance dose of Suboxone when detained/arrested (last dose within 2 days of incarceration), resulting in immediate cessation of Suboxone without tapering
  • Currently released from detention
  • Willing to complete one-time questionnaire
  • Willing to sign informed consent

Exclusion Criteria for Substudy:

  • Any medical or psychiatric condition that, in the opinion of the investigator, would make participation in the study unsafe, or would otherwise interfere with the study objectives or interpretation
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China,   Thailand
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00270257
Other Study ID Numbers  ICMJE HPTN 058
10144 ( Registry Identifier: DAIDS ES )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party National Institute of Allergy and Infectious Diseases (NIAID)
Study Sponsor  ICMJE National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators  ICMJE National Institute on Drug Abuse (NIDA)
Investigators  ICMJE
Study Chair: David Metzger, PhD Center for Studies of Addiction, University of Pennsylvania
PRS Account National Institute of Allergy and Infectious Diseases (NIAID)
Verification Date December 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP