Status:
COMPLETED
Single Tablet Regimen (STR) Simplification Study for HIV-1 Infected Patients
Lead Sponsor:
Gilead Sciences
Collaborating Sponsors:
Bristol-Myers Squibb
Conditions:
HIV Infections
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief Summary
To compare the effectiveness (efficacy, safety \& tolerability) of a Single Tablet Regimen of efavirenz/emtricitabine/tenofovir DF to subjects continuing on unmodified HAART as measured by the proport...
Eligibility Criteria
Inclusion
- HIV-1 positive patients who have maintained an HIV-1 viral load \<200 copies/mL, for at least 3 months.
- Patients must be on their first HAART or have documented viral suppression on a PI-based regimen at the time of any prior change in therapy.
- HAART must consist of either:
- A PI (with or without ritonavir) + at least 2 NRTIs or
- An NNRTI + at least 2 NRTIs.
- Negative serum pregnancy test.
Exclusion
- Patients who have taken any NNRTI prior to their current therapy.
- Patients who have taken a NRTI-only therapy for greater than 7 days prior to their current therapy.
- Patients who are currently taking EFV+FTC+TDF.
- Patients who have a creatinine clearance of \<60 mL/min by Cockcroft-Gault estimation.
- Patients who have experienced virologic failure with any previous ARV therapy.
- Patients who have documented resistance to any of the study agents at any time in the past.
Key Trial Info
Start Date :
July 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2008
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT00365612
Start Date
July 1 2006
End Date
January 1 2008
Last Update
April 10 2008
Active Locations (56)
Enter a location and click search to find clinical trials sorted by distance.
1
Hobson City, Alabama, United States, 36201
2
Phoenix, Arizona, United States, 85006
3
Beverly Hills, California, United States, 90211
4
Long Beach, California, United States, 90813