Status:
COMPLETED
Tenofovir DF + Efavirenz (TDF+EFV) Versus Tenofovir DF + Efavirenz + Lamivudine (TDF+EFV+3TC) Maintenance Regimen in Virologically Controlled Patients: COOL Trial
Lead Sponsor:
Gilead Sciences
Conditions:
HIV Infections
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
Brief Summary
Primary objective: Evaluation of the efficacy of TDF+3TC+EFV versus TDF+EFV QD to maintain plasma HIV-1 RNA BLQ (\< 50 copies/mL) (c/mL) at 48 weeks (W48) Main Secondary objectives: Comparison of th...
Eligibility Criteria
Inclusion
- Stable HAART ≥ 3 months
- HIV-1 RNA \< 50 c/mL ≥ 6 months
- No HAART failure history
Exclusion
- Weight \> 45 kg
- No CD4+ cell count criteria
- No significant laboratory or clinical abnormalities
- Creatinine Clearance \> 60 mL/min
Key Trial Info
Start Date :
March 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2005
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT00643968
Start Date
March 1 2003
End Date
September 1 2005
Last Update
June 30 2008
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
France and French West Indies
Paris, France