- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00809718
The Effect of Rifapentine on Raltegravir
The Effect of Rifapentine on Plasma Concentrations of Raltegravir
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 1
Kontakter og lokationer
Studiesteder
-
-
Texas
-
San Antonio, Texas, Forenede Stater, 78229
- University of Texas Health Science Center
-
San Antonio, Texas, Forenede Stater, 78229
- Audie L Murphy Veterans Administration Hospital
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Andet: raltegravir and rifapentine
Concomitant administration of raltegravir and rifapentine in healthy volunteers
|
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
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Raltegravir pharmacokinetics (Cmin and AUC)
Tidsramme: Eight weeks
|
Eight weeks
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Tolerability and safety of concomitant raltegravir and rifapentine administration
Tidsramme: Eight weeks
|
Eight weeks
|
Samarbejdspartnere og efterforskere
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Marc Weiner, M.D., The University of Texas Health Science Center at San Antonio
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Molekylære mekanismer for farmakologisk virkning
- Anti-infektionsmidler
- Antivirale midler
- Nukleinsyresyntesehæmmere
- Enzymhæmmere
- Anti-HIV-midler
- Anti-retrovirale midler
- Antibakterielle midler
- Leprostatiske midler
- Cytokrom P-450 enzyminducere
- Cytokrom P-450 CYP3A inducere
- HIV-integrasehæmmere
- Integrasehæmmere
- Antituberkulære midler
- Antibiotika, Antituberkulær
- Cytokrom P-450 CYP2B6 inducere
- Cytokrom P-450 CYP2C8 inducere
- Cytokrom P-450 CYP2C19 inducere
- Cytokrom P-450 CYP2C9 inducere
- Raltegravir kalium
- Rifapentin
- Rifampin
Andre undersøgelses-id-numre
- TBTC 29RR
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