The Effect of Rifapentine on Raltegravir

• Status: Completed
• Trial end date: 2011-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The aim of this study is to study the effect of rifapentine on plasma concentrations of raltegravir.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: The University of Texas Health Science Center at San Antonio
• Collaborators: Centers for Disease Control and Prevention; Merck Sharp & Dohme Corp.; VA Office of Research and Development
• Treatments: Raltegravir Potassium; Rifampin; Rifapentine

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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