Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 5:00 AM
Ignite Modification Date:
2025-12-25 @ 5:00 AM
NCT ID:
NCT00809718
Eligibility 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
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
99 Years
Study:
NCT00809718
Study Brief:
Protocol Section:
NCT00809718