The Raltegravir and Ribavirin Pharmacokinetics (PK) Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Imperial College London
ClinicalTrials.gov Identifier:
NCT00982553
First received: September 22, 2009
Last updated: November 4, 2011
Last verified: November 2011
Results First Received: February 28, 2011  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: HIV Infections
Interventions: Drug: Ribavirin
Drug: Raltegravir

  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
  • Recruitment was between 24/09/2009 and 29/10/2009.
  • 14 subjects were enrolled.
  • The study took place at a specialist research unit at an National Health Service (NHS) hospital.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
  • Subjects were healthy volunteers.
  • There was a 21 day washout for any prescribed and 7 days for over the counter medication before enrolment.
  • The subjects were permitted to take paracetamol during the study but all others were excluded for the duration of the trial.

Reporting Groups
  Description
All Subjects

All subjects received the same study therapy as follows:

Day 1 Ribavirin single dose 800 mg oral followed by intensive PK monitoring. Day 2 - 14 washout phase Day 15 - 18 raltegravir 400 mg twice daily followed by by intensive PK monitoring on day 18.

Day 19 raltegravir 400 mg plus ribavirin 800 mg by intensive PK monitoring.


Participant Flow:   Overall Study
    All Subjects  
STARTED     14  
COMPLETED     14  
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
All Subjects

All subjects received the same study therapy as follows:

Day 1 Ribavirin single dose 800 mg oral followed by intensive PK monitoring. Day 2 - 14 washout phase Day 15 - 18 raltegravir 400 mg twice daily followed by by intensive PK monitoring on day 18.

Day 19 raltegravir 400 mg plus ribavirin 800 mg by intensive PK monitoring.


Baseline Measures
    All Subjects  
Number of Participants  
[units: participants]
  14  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     14  
>=65 years     0  
Age  
[units: years]
Mean ± Standard Deviation
  35  ± 10  
Gender  
[units: participants]
 
Female     4  
Male     10  
Region of Enrollment  
[units: participants]
 
United Kingdom     14  



  Outcome Measures
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1.  Primary:   Ribavirin Alone Maximum Plasma Concentration   [ Time Frame: Day 1 ]

2.  Primary:   Raltegravir Alone Maximum Plasma Concentration   [ Time Frame: Day 19 ]

3.  Primary:   Ribavirin Maximum Plasma Concentration When Co-administered   [ Time Frame: Day 20 ]

4.  Primary:   Raltegravir Maximum Plasma Concentrations When Co-administered   [ Time Frame: Day 20 ]


  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:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr Alan Winston
Organization: Imperial College
phone: +44 (0)20 3312 1603
e-mail: a.winston@imperial.ac.uk


No publications provided


Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT00982553     History of Changes
Other Study ID Numbers: 2009-010005-36
Study First Received: September 22, 2009
Results First Received: February 28, 2011
Last Updated: November 4, 2011
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency