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NCT00764465 · ClinicalTrials.gov registry record · Phase 2
An Interaction Study to Assess Drug Levels in Healthy Adult Subjects
A Phase 2 study of Healthy, sponsored by Garden State Infectious Disease Associates, PA.
- Completed
- Registry status
- Phase 2
- Development phase
- 45
- Enrollment target
- 1
- Study location
NCT00764465: Completed Phase 2 study of Healthy, sponsored by Garden State Infectious Disease Associates, PA.
NCT00764465 is a Phase 2 study of Healthy that has completed, run by Garden State Infectious Disease Associates, PA. The registered enrollment target is 45 participants, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (93% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00764465, a Phase 2 study of Healthy, has completed, sponsored by Garden State Infectious Disease Associates, PA.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 45 participants
- Enrollment target
- 1
- Study location
Study Summary
To date, no study has investigated whether there is a drug interaction between the protease inhibitor fosamprenavir and the entry inhibitor maraviroc. COL112237 is a randomized, open-label, 6-arm, 3-period, drug interaction study to assess steady-state plasma amprenavir (APV) and maraviroc (MVC) pharmacokinetics in 48 healthy, HIV-negative adults after administration of a 7-day regimen of MVC 300mg 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 MVC 300mg 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.
Conditions Studied
Interventions
- DRUG Ritonavir
- DRUG Maraviroc
- DRUG Fosamprenavir
Study Locations (1)
New Jersey
- Garden State Infectious Disease Associates,PA - Voorhees Township
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 2008-10 |
| Est. Completion | 2008-12 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00764465
The ClinicalTrials.gov registry entry for NCT00764465 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 45 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (93% lower). The listed sponsor is Garden State Infectious Disease Associates, PA, which has 2 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Healthy appearing as the primary indexed condition, and to 3 interventions - of which Ritonavir is the first listed.
NCT00764465 reports 1 study location spanning 1 distinct geographic area - top geographies include New Jersey.
Frequently Asked Questions
What is clinical trial NCT00764465 about?
NCT00764465 is a clinical study titled "An Interaction Study to Assess Drug Levels in Healthy Adult Subjects". To date, no study has investigated whether there is a drug interaction between the protease inhibitor fosamprenavir and the entry inhibitor maraviroc. COL112237 is a randomized, open-label, 6-arm, 3-period, drug interaction study to assess steady-state plasma amprenavir (APV) and maraviroc (MVC) pha...
What is the current status of trial NCT00764465?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 45 participants. The study started on 2008-10. Estimated completion is 2008-12.
What conditions does trial NCT00764465 study?
This clinical trial studies the following conditions: Healthy.
What interventions are being tested in trial NCT00764465?
The interventions under investigation include: Ritonavir (DRUG), Maraviroc (DRUG), Fosamprenavir (DRUG).
Who is sponsoring clinical trial NCT00764465?
This trial is sponsored by Garden State Infectious Disease Associates, PA, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00764465 being conducted?
This trial has 1 study location across New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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