The Effect of Rifapentine on Raltegravir
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Purpose
The aim of this study is to study the effect of rifapentine on plasma concentrations of raltegravir.
| Condition | Intervention | Phase |
|---|---|---|
|
Healthy |
Drug: Raltegravir and rifapentine |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Pharmacokinetics Study Intervention Model: Crossover Assignment Masking: Open Label |
| Official Title: | The Effect of Rifapentine on Plasma Concentrations of Raltegravir |
- Raltegravir pharmacokinetics (Cmin and AUC) [ Time Frame: Eight weeks ] [ Designated as safety issue: No ]
- Tolerability and safety of concomitant raltegravir and rifapentine administration [ Time Frame: Eight weeks ] [ Designated as safety issue: Yes ]
| Enrollment: | 27 |
| Study Start Date: | February 2009 |
| Study Completion Date: | August 2011 |
| Primary Completion Date: | May 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
raltegravir and rifapentine
Concomitant administration of raltegravir and rifapentine in healthy volunteers
|
Drug: Raltegravir and rifapentine
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 Other Names:
|
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 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations| United States, Texas | |
| University of Texas Health Science Center | |
| San Antonio, Texas, United States, 78229 | |
| Audie L Murphy Veterans Administration Hospital | |
| San Antonio, Texas, United States, 78229 | |
| Principal Investigator: | Marc Weiner, M.D. | University of Texas Health Science Center at San Antonio |
More Information
No publications provided
| Responsible Party: | The University of Texas Health Science Center at San Antonio |
| ClinicalTrials.gov Identifier: | NCT00809718 History of Changes |
| Other Study ID Numbers: | TBTC 29RR |
| Study First Received: | December 15, 2008 |
| Last Updated: | September 10, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by The University of Texas Health Science Center at San Antonio:
|
Raltegravir Pharmacokinetics Rifapentine Drug Kinetics |
Additional relevant MeSH terms:
|
Rifapentine Rifampin Antibiotics, Antitubercular Anti-Bacterial Agents Anti-Infective Agents Therapeutic Uses |
Pharmacologic Actions Antitubercular Agents Leprostatic Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Nucleic Acid Synthesis Inhibitors |
ClinicalTrials.gov processed this record on May 22, 2013