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

This study has been terminated.
(DSMB halted the study due to futility as a result of lower than anticipated HIV incidence rates)
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00270257
First received: December 22, 2005
Last updated: October 14, 2016
Last verified: October 2016
Results First Received: November 5, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Conditions: HIV Infections
Opioid-Related Disorders
Intervention: Drug: Buprenorphine/Naloxone

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations

The sites were selected based on prior HIV incidence rates among opiate injectors.

At the first scheduled interim analyses, when 25% of the participants had completed 104 weeks on study, the Data Safety Monitoring Board (DSMB) halted the study due to futility as a result of lower than anticipated HIV incidence rates.


Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The study represented the first use of buprenorphine-naloxone as a treatment for opiate dependence in each community, thus implementation of the study and recruitment of participants included a significant effort devoted to community engagement and education. Each site had an active community advisory board (CAB).

Reporting Groups
  Description
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

Buprenorphine/Naloxone: Oral tablet

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.

Buprenorphine/Naloxone: Oral tablet


Participant Flow:   Overall Study
    Long Term Medication Assisted Treatment (LT-MAT)   Short Term Medication Assisted Treatment (ST-MAT)
STARTED   623   628 [1] 
Week 8   510   443 
Week 26   460   440 
Week 52   362   340 
Week 78   283   285 
Visit 104   211   204 
COMPLETED   211   204 
NOT COMPLETED   412   424 
Data Safety Monitoring Board (DSMB) halt                412                424 
[1] 1 excluded from analysis (enrollment date exceeded eligibility window by 13 days)



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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

Buprenorphine/Naloxone: Oral tablet

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.

Buprenorphine/Naloxone: Oral tablet

Total Total of all reporting groups

Baseline Measures
   Long Term Medication Assisted Treatment (LT-MAT)   Short Term Medication Assisted Treatment (ST-MAT)   Total 
Overall Participants Analyzed 
[Units: Participants]
 623   627   1250 
Age, Customized 
[Units: Years]
Median (Inter-Quartile Range)
 33 
 (27 to 39) 
 34 
 (28 to 39) 
 34 
 (28 to 39) 
Gender 
[Units: Participants]
     
Female   49   50   99 
Male   574   577   1151 
Region of Enrollment 
[Units: Participants]
     
China   522   527   1049 
Thailand   101   100   201 
Years of Injection 
[Units: Years]
Median (Inter-Quartile Range)
 7 
 (3 to 12) 
 7 
 (3 to 12) 
 7 
 (3 to 12) 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Evidence of HIV-1 Infection or Death for Visits up to 104 Weeks   [ Time Frame: For visits up to week 104 ]

2.  Secondary:   Number of Participants With Urinalysis Results Positive for Opiates   [ Time Frame: Measured through Week 104 ]

3.  Secondary:   Self-report of Continued Injection Opiate Use in the Last 30 Days   [ Time Frame: Measured through Week 104 ]

4.  Secondary:   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 ]

5.  Secondary:   Self-reported Number of Injections in the Last Month   [ Time Frame: Measured through Week 104 ]

6.  Secondary:   Incident Hepatitis C Infections for Thailand and China   [ Time Frame: Measured through week 156 in Thailand and 104 weeks in China ]

7.  Secondary:   Incident Hepatitis B Infections   [ Time Frame: Measured through week 52 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Senior Statistical Analyst
Organization: Fred Hutchinson Cancer Research Center
phone: 206-667-6167
e-mail: geetha@scharp.org


Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00270257     History of Changes
Other Study ID Numbers: HPTN 058
10144 ( Registry Identifier: DAIDS ES )
Study First Received: December 22, 2005
Results First Received: November 5, 2015
Last Updated: October 14, 2016
Health Authority: United States: Food and Drug Administration