Status:
COMPLETED
The Effect of Rifapentine on Raltegravir
Lead Sponsor:
The University of Texas Health Science Center at San Antonio
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Centers for Disease Control and Prevention
Conditions:
Healthy
Eligibility:
All Genders
18-99 years
Phase:
PHASE1
Brief Summary
The aim of this study is to study the effect of rifapentine on plasma concentrations of raltegravir.
Detailed Description
Primary Objective To compare the pharmacokinetics parameter values (geometric mean Cmin and AUC) of raltegravir at 400 mg q12h alone to raltegravir at 400 mg q12h co-administered in combination with ...
Eligibility Criteria
Inclusion
- Male or non-pregnant, non-nursing female age \> 18 years in good health
- Provision of informed consent for the study.
- HIV-uninfected. A prior negative HIV test (ELISA) must be obtained before enrollment.
- Willingness to have PK sampling in a day clinic or to be admitted overnight to a hospital on three occasions.
- Women of child-bearing potential must agree to practice an adequate method of birth control during the study and for 30 days after the last dose of study medication. Barrier methods of contraception or abstinence from sexual activity are satisfactory methods of birth control.
- Karnofsky score ≥ 90.
- Laboratory screening before enrollment:
- Hematocrit \> 30 percent (most recent value)
- AST \< 2 times the upper limit of normal
- ALT \< 2 times the upper limit of normal
- Bilirubin \< 2 times the upper limit of normal
- Creatinine \< 1.5 times the upper limit of normal
- Negative urine drug screen
Exclusion
- Pregnancy or breast-feeding.
- Use of a medication or food that has the potential to alter the concentrations of raltegravir or rifapentine, within the 14 days prior to or during the periods of pharmacokinetic monitoring.
- Known intolerance to raltegravir or rifamycin antibiotics or prior use in the last 30 days.
- Weight less than 46 kg or greater than 102 kg.
- Prior gastrointestinal surgery.
- Infection with Hepatitis B or Hepatitis C by serologies.
- Co-morbidity for which concomitant, current medications are taken regularly. If concomitant medications are taken intermittently, these medications should not have potential to alter the concentrations of raltegravir or rifapentine.
- Current imprisonment
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2011
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT00809718
Start Date
February 1 2009
End Date
August 1 2011
Last Update
October 22 2015
Active Locations (2)
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1
Audie L Murphy Veterans Administration Hospital
San Antonio, Texas, United States, 78229
2
University of Texas Health Science Center
San Antonio, Texas, United States, 78229