ClinicalTrials.gov
ClinicalTrials.gov Menu

The Raltegravir and Ribavirin Pharmacokinetics (PK) Study

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: NCT00982553
Recruitment Status : Completed
First Posted : September 23, 2009
Results First Posted : June 13, 2011
Last Update Posted : November 7, 2011
Sponsor:
Information provided by (Responsible Party):
Imperial College London

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition HIV Infections
Interventions Drug: Ribavirin
Drug: Raltegravir
Enrollment 14
Recruitment Details
  • 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
  • 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.
Arm/Group Title All Subjects
Hide Arm/Group Description

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.

Period Title: Overall Study
Started 14
Completed 14
Not Completed 0
Arm/Group Title All Subjects
Hide Arm/Group Description

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.

Overall Number of Baseline Participants 14
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants
<=18 years
0
   0.0%
Between 18 and 65 years
14
 100.0%
>=65 years
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 14 participants
35  (10)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants
Female
4
  28.6%
Male
10
  71.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United Kingdom Number Analyzed 14 participants
14
1.Primary Outcome
Title Ribavirin Alone Maximum Plasma Concentration
Hide Description On day 1 participants were administered a single dose of Ribavirin 800mg and then intensive pharmacokinetic blood samples were collected at 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8 and 12 hours
Time Frame Day 1
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Per protocol
Arm/Group Title Raltegravir and Ribavirin
Hide Arm/Group Description:
Single dose ribavirin 800mg administered on day 1 followed by raltegravir 400 mg twice daily on day 15-19 then on day 20 single dose of both ribavirin and raltegravir administered together
Overall Number of Participants Analyzed 14
Geometric Mean (95% Confidence Interval)
Unit of Measure: ng/mL
630.09
(490.91 to 808.54)
2.Primary Outcome
Title Raltegravir Alone Maximum Plasma Concentration
Hide Description After a 14 day wash out participants took raltegravir 400 mg twice daily for 4 days. on day 19 they attended for intensive pharmacokinetic tests at 0 (pre-dose of raltegravir 400mg)then 0.5, 1, 2, 3, 4, 6, 8 and 12 hours
Time Frame Day 19
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Raltegravir and Ribavirin
Hide Arm/Group Description:
Single dose ribavirin 800mg administered on day 1 followed by raltegravir 400 mg twice daily on day 15-19 then on day 20 single dose of both ribavirin and raltegravir administered together
Overall Number of Participants Analyzed 14
Geometric Mean (95% Confidence Interval)
Unit of Measure: ng/mL
2227.41
(1489.36 to 3331.19)
3.Primary Outcome
Title Ribavirin Maximum Plasma Concentration When Co-administered
Hide Description On day 20 participants were administered raltegravir 400 mg and ribavirin 800 mg this was followed by intensive pharmacokinetic testing at 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, and 12 hours.
Time Frame Day 20
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Raltegravir and Ribavirin
Hide Arm/Group Description:
Single dose ribavirin 800mg administered on day 1 followed by raltegravir 400 mg twice daily on day 15-19 then on day 20 single dose of both ribavirin and raltegravir administered together
Overall Number of Participants Analyzed 14
Geometric Mean (95% Confidence Interval)
Unit of Measure: ng/mL
496.71
(407.38 to 605.76)
4.Primary Outcome
Title Raltegravir Maximum Plasma Concentrations When Co-administered
Hide Description On day 20 participants were administered raltegravir 400 mg and ribavirin 800 mg this was followed by intensive pharmacokinetic testing at 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, and 12 hours.
Time Frame Day 20
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Raltegravir and Ribavirin
Hide Arm/Group Description:
Single dose ribavirin 800mg administered on day 1 followed by raltegravir 400 mg twice daily on day 15-19 then on day 20 single dose of both ribavirin and raltegravir administered together
Overall Number of Participants Analyzed 14
Geometric Mean (95% Confidence Interval)
Unit of Measure: ng/mL
2591.19
(1778.28 to 3774.85)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title All Subjects
Hide Arm/Group Description

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.

All-Cause Mortality
All Subjects
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
All Subjects
Affected / at Risk (%)
Total   0/14 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
All Subjects
Affected / at Risk (%)
Total   0/14 (0.00%) 
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
Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT00982553     History of Changes
Other Study ID Numbers: 2009-010005-36
First Submitted: September 22, 2009
First Posted: September 23, 2009
Results First Submitted: February 28, 2011
Results First Posted: June 13, 2011
Last Update Posted: November 7, 2011