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Buprenorphine/Raltegravir Pharmacokinetic Interaction Study

This study has been completed.
Sponsor:
Collaborators:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
R. Douglas Bruce, MD, MA, Yale University
ClinicalTrials.gov Identifier:
NCT00858962
First received: March 6, 2009
Last updated: October 19, 2012
Last verified: October 2012
Results First Received: May 31, 2012  
Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics/Dynamics Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: HIV Infection
HIV Infections
Intervention: Drug: Raltegravir

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Raltegravir (400mg Twice Per Day) Subjects were maintained on Buprenorphine/Naloxone (BUP/NLX) for 3 weeks prior to Raltegravir administration to achieve steady state during baseline. Subsequently, subjects were co-administered raltegravir (400mg twice per day)and BUP/NLX. All subjects received 16/4 mg of BUP/NLX daily, except for 1 patient who received 32/8 mg daily.

Participant Flow:   Overall Study
    Raltegravir (400mg Twice Per Day)  
STARTED     12  
COMPLETED     12  
NOT COMPLETED     0  



  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
Raltegravir (400mg Twice Per Day) Subjects were maintained on Buprenorphine/Naloxone (BUP/NLX) for 3 weeks prior to Raltegravir administration to achieve steady state during baseline. Subsequently, subjects were co-administered raltegravir (400mg twice per day)and BUP/NLX. All subjects received 16/4 mg of BUP/NLX daily, except for 1 patient who received 32/8 mg daily.

Baseline Measures
    Raltegravir (400mg Twice Per Day)  
Number of Participants  
[units: participants]
  12  
Age  
[units: years]
Mean ( Full Range )
  44  
  ( 30 to 57 )  
Gender  
[units: participants]
 
Female     4  
Male     8  
Region of Enrollment  
[units: participants]
 
United States     12  



  Outcome Measures

1.  Primary:   Area Under the Curve (AUC) of BUP/NLX With Raltegravir (hr*ng/mL)   [ Time Frame: 6-14 days after beginning co-administration of drugs ]


  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
The sample size was small, though within the range of similar drug-drug interaction studies. This study utilized a within-subject design with patients acting as their own controls (thereby resulting in less intra-patient variability).


  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 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.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: R. Douglas Bruce, MD, MA
Organization: Yale University AIDS Program
phone: (203) 737-6133
e-mail: robert.bruce@yale.edu


No publications provided


Responsible Party: R. Douglas Bruce, MD, MA, Yale University
ClinicalTrials.gov Identifier: NCT00858962     History of Changes
Other Study ID Numbers: 0811004456, R01DA025932
Study First Received: March 6, 2009
Results First Received: May 31, 2012
Last Updated: October 19, 2012
Health Authority: United States: Institutional Review Board