N/A
Completed N=44
An Interaction Study to Assess Drug Levels in Healthy Adult Subjects
Healthy
Source: ClinicalTrials.gov NCT00614991 ↗
Enrolled (actual)
44
Serious AEs
0.0%
Results posted
Jan 2016
Primary outcomePrimary: Cmin/Cmax: Steady-state Plasma Amprenavir (APV) Pharmacokinetics (PK) Following Admin of Fosamprenavir (FPV) 1400mg BID, FPV 700mg/Ritonavir (RTV) 100 mg BID, or FPV 1400mg/RTV 100mg QD With and Without Concurrent Raltegravir (RTG) 400mg BID. — 0.67; 0.67; 0.83; 0.83 ng/mL
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cmin/Cmax: Steady-state Plasma Amprenavir (APV) Pharmacokinetics (PK) Following Admin of Fosamprenavir (FPV) 1400mg BID, FPV 700mg/Ritonavir (RTV) 100 mg BID, or FPV 1400mg/RTV 100mg QD With and Without Concurrent Raltegravir (RTG) 400mg BID. |
0.67; 0.67; 0.83; 0.83; 0.75; 1.27 | — |
| PRIMARY AUC: Steady-state Plasma Amprenavir (APV) Pharmacokinetics (PK) Following Admin of Fosamprenavir (FPV) 1400mg BID, FPV 700mg/Ritonavir (RTV) 100 mg BID, or FPV 1400mg/RTV 100mg QD With and Without Concurrent Raltegravir (RTG) 400mg BID. |
0.81; 0.75; 1.13 | — |
| PRIMARY CL/F: Steady-state Plasma Amprenavir (APV) Pharmacokinetics (PK) Following Administration of Fosamprenavir (FPV) 1400mg BID, FPV 700mg/Ritonavir (RTV) 100 mg BID, or FPV 1400mg/RTV 100mg QD With and Without Concurrent Raltegravir (RTG) 400mg BID. |
1.02; 2.30; 1.46 | — |
| PRIMARY Cmin/Cmax: Steady-state Plasma RTG PK Following Admin of FPV 1400mg BID, FPV 700mg/RTV 100 mg BID, or FPV 1400mg/RTV 100mg QD With and Without Concurrent RTG 400mg BID. |
0.32; 0.46; 0.59; 0.95; 0.44; 0.85 | — |
| PRIMARY AUC: Steady-state Plasma Amprenavir (APV) Pharmacokinetics (PK) Following Administration of Fosamprenavir (FPV) 1400mg BID, FPV 700mg/Ritonavir (RTV) 100 mg BID, or FPV 1400mg/RTV 100mg QD With and Without Concurrent Raltegravir (RTG) 400mg BID. |
0.71; 0.46; 0.70 | — |
| SECONDARY Number of Participants Who Experienced Adverse Events |
0; 4; 6; 5; 5; 4 | — |
Eligibility 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 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.
Data sourced from ClinicalTrials.gov (NCT00614991). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.