The Effect of Rifapentine on Raltegravir

Study Overview
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Brief Summary
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The aim of this study is to study the effect of rifapentine on plasma concentrations of raltegravir.

Detailed Description
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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 rifapentine 900 mg once weekly, and to raltegravir at 400 mg q12h co-administered in combination with rifapentine 600 mg per day, 5 days per week. Secondary Objective To assess the tolerability and safety of concomitant administration of raltegravir and rifapentine in healthy volunteers. Design This study is a three-period, one-sequence, open label, pharmacokinetic study of the raltegravir-rifapentine interactions in healthy, male and female volunteers. Up to 21 subjects may be enrolled to achieve the estimated sample size of 16 completing subjects. All study medication will be self-administered except on the days of pharmacokinetic sampling. All subjects will participate in three sampling periods and be studied in a day clinic or be admitted overnight to a hospital.

Official Title
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The Effect of Rifapentine on Plasma Concentrations of Raltegravir

Conditions
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Healthy

Intervention / Treatment
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* Drug: Raltegravir and rifapentine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: raltegravir and rifapentine<br>Concomitant administration of raltegravir and rifapentine in healthy volunteers | Drug: Raltegravir and rifapentine<br>* Period 1- Raltegravir 400 mg q12h by mouth for 4 days Period 2- Rifapentine 900 mg taken by mouth once per week for 3 doses and raltegravir 400 mg q12h by mouth for 4 days Period 3- Rifapentine 600 mg taken by mouth once daily for 5 of 7 days per week for 10 doses and raltegravir 400 mg q12h by mouth for 4 days<br>* Other names: Priftin - Rifapentine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Raltegravir pharmacokinetics (Cmin and AUC) |  | Eight weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tolerability and safety of concomitant raltegravir and rifapentine administration |  | Eight weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Raltegravir, Pharmacokinetics, Rifapentine, Drug Kinetics