An Interaction Study to Assess Drug Levels in Healthy Adult Subjects - Full Text View

Purpose

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 BID alone and after 14-day regimens of unboosted fosamprenavir (FPV) 1400mg twice daily (BID), FPV 700mg/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, 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

Condition	Intervention
Healthy	Drug: Raltegravir


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Factorial Assignment Masking: Open Label
Official Title:	Steady-State Plasma Amprenavir and Raltegravir Pharmacokinetics After Fosamprenavir and Raltegravir Are Each Administered Alone Versus in Combination With or Without Ritonavir Boosting in Healthy Adult Subjects

Resource links provided by NLM:

Drug Information available for: Raltegravir

U.S. FDA Resources

Further study details as provided by Garden State Infectious Disease Associates, PA:

Primary Outcome Measures:

• To compare steady-state plasma APV PK following administration of FPV 1400mg BID, FPV 700mg/RTV 100 mg BID, or FPV 1400mg/RTV 100mg QD with and without concurrent RTG 400mg BID. • To compare steady-state plasma RTG PK following administration of RT [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

• To evaluate the safety and tolerability of RTG 400mg BID plus FPV (when given as either 1400mg BID, 1400mg/RTV 100mg QD or 700mg/RTV 100mg BID) [ Time Frame: 6 months ] [ Designated as safety issue: No ]


Enrollment:	44
Study Start Date:	January 2008
Study Completion Date:	March 2008
Primary Completion Date:	March 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 1 RTG 400mg BID; FPV 1400mg BID; FPV 1400mg BID + RTG 400mg BID	Drug: Raltegravir 400mg BID
Active Comparator: 2 RTG 400mg BID; FPV 1400mg BID + RTG 400mg BID; FPV 1400mg BID	Drug: Raltegravir 400mg BID
Active Comparator: 3 RTG 400mg BID; FPV 700mg BID + RTV 100mg BID; FPV 700mg BID + RTV 100mg BID + RTG 400mg BID	Drug: Raltegravir 400mg BID
Active Comparator: 4 RTG 400mg BID; FPV 700mg BID + RTV 100mg BID + RTG 400mg BID; FPV 700mg BID + RTV 100mg BID	Drug: Raltegravir 400mg BID
Active Comparator: 5 RTG 400mg BID; FPV 1400mg QD + RTV 100mg QD; FPV 1400mg QD + RTV 100mg QD + RTG 400mg BID	Drug: Raltegravir 400mg BID
Active Comparator: 6 RTG 400mg BID; FPV 1400mg QD + RTV 100mg QD + RTG 400mg BID; FPV 1400mg QD + RTV 100mg QD	Drug: Raltegravir 400mg BID

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Eligibility


Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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/mm3; platelets > 50,000/mm3; 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.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00614991

Sponsors and Collaborators

Garden State Infectious Disease Associates, PA

GlaxoSmithKline

Investigators


Principal Investigator:	David V Condoluci, DO	GSIDA

More Information

No publications provided


Responsible Party:	David V Condoluci, DO Medical Director, GSIDA
ClinicalTrials.gov Identifier:	NCT00614991 History of Changes
Other Study ID Numbers:	COL111242
Study First Received:	February 1, 2008
Last Updated:	April 14, 2008
Health Authority:	United States: Institutional Review Board

Keywords provided by Garden State Infectious Disease Associates, PA:


Healthy Subjects Pharmacokinetics study Pharmacokinetics of medications

ClinicalTrials.gov processed this record on March 03, 2015