An Interaction Study to Assess Drug Levels in Healthy Adult Subjects

• Status: Completed
• Trial end date: 2008-03-01
• Target enrollment: 0
• Participant gender: All

Summary

To date, no study has investigated whether there is a drug interaction between the protease inhibitor fosamprenavir and the integrase inhibitor raltegravir. COL111242 is a randomized, open-label, 6-arm, 3-period, drug interaction study to assess steady-state plasma amprenavir (APV) and raltegravir (RTG) pharmacokinetics in 48 healthy, HIV-negative adults after administration of a 7-day regimen of RTG 400mg twice a day (BID) alone and after 14-day regimens of unboosted fosamprenavir (FPV) 1400mg twice daily (BID), FPV 700mg/Ritonavir (RTV) 100mg BID, or FPV 1400mg/ritonavir (RTV) 100mg once daily (QD) with and without concurrent RTG 400mg BID. Blood samples for drug concentration measurement will be collected over 12 hours at the end of each dosing period. Subjects will undergo a physical examination, complete blood count (CBC) with differential, HIV test, hepatitis B/C test, liver function test, renal function analysis, and lipid panel at screening, and all of these tests, except those for HIV and hepatitis B/C, will be repeated at follow-up post-study. Adverse events and adherence (by pill count and medication diary) will be assessed by the investigator/study personnel at the end of each dosing period

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Garden State Infectious Disease Associates, PA
• Collaborator: GlaxoSmithKline
• Treatments: Fosamprenavir; Raltegravir Potassium; Ritonavir

Criteria

Inclusion Criteria:

• Age > 18 years

• Adequate renal function (calculated creatinine clearance via Cockcroft and Gault method (CrCl) > 50 mL/min);

• Adequate hepatic function (total bilirubin < 2.5mg/dL; hepatic transaminases < 5x normal);

• Adequate hematologic function (absolute neutrophil count [ANC] > 750 neutrophils/mm^3; platelets > 50,000/mm^3; hematocrit > 25%);

• Non-smoker

• Willingness and ability to adhere to treatment and follow-up procedures;

• The ability to understand and sign a written informed consent form.

Exclusion Criteria:

• They fail to meet the above inclusion criteria

• Have an active infection that required parenteral antibiotics or hospitalization within 2 weeks prior to enrollment

• A history of or documented gastrointestinal diseases that impact drug absorption

• Are receiving medications that are contraindicated or result in significant drug-drug interactions with RTV (including, but not limited to, triazolam, astemizole, ergot medications, cisapride, midazolam, bepridil, or rifampin)

• Have a significant documented sulfa allergy (e.g., Stevens-Johnson Syndrome)

• HIV, Hepatitis B or C positive

• Cigarette/cigar/pipe smokers

• They are pregnant or lactating. All other women of childbearing potential must use effective method(s) of contraception throughout the study participation and for 30 days following the end of the study.