The Effect of Rifapentine on Raltegravir

Completed · Phase 1

Conditions studied: Healthy

In brief

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

Key facts

Study ID

NCT00809718

Run by

The University of Texas Health Science Center at San Antonio

People needed

27

Starts

2009-02-01

Expected to finish

2011-08-01

Last updated by the study team

2015-10-22

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Audie L Murphy Veterans Administration Hospital — San Antonio, Texas, United States
• University of Texas Health Science Center — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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