Status:
COMPLETED
An Interaction Study to Assess Drug Levels in Healthy Adult Subjects
Lead Sponsor:
Garden State Infectious Disease Associates, PA
Collaborating Sponsors:
GlaxoSmithKline
Conditions:
Healthy
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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-ar...
Detailed Description
This randomized, open-label, six-arm, three-period drug interaction study will recruit 48 healthy volunteers so as to obtain a minimum of 36 evaluable subjects at a single study center in the U.S. The...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2008
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT00614991
Start Date
January 1 2008
End Date
March 1 2008
Last Update
January 29 2016
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