Status:
COMPLETED
FOTO: Five Consecutive Days on Treatment With Efavirenz, Tenofovir, and Emtricitabine Followed by Two Days Off Treatment Versus Continuous Treatment
Lead Sponsor:
Community Research Initiative of New England
Collaborating Sponsors:
The Campbell Foundation
Conditions:
HIV Infections
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
For people with HIV who are currently taking specific medications (including Sustiva (efavirenz)) and have no detectable viral load, this study tracks how patients do if they take their medications fo...
Detailed Description
The purpose of this study is to evaluate virologic control of a weekly schedule of 5 days of treatment followed by two days off treatment versus continuous treatment with the same regimen. This is a l...
Eligibility Criteria
Inclusion
- Age 18 years or older
- CD4 count \> or = 200
- Viral load \< 50
- Treatment with a regimen containing efavirenz and tenofovir and lamivudine or emtricitabine for at least 90 days prior to screening
Exclusion
- Detectable HIV RNA on an ultrasensitive assay within the 90 days preceding screening
- Prior evidence of intermediate or high level resistance to efavirenz, tenofovir or cytidine analogues
- Hepatitis B infection
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00414635
Start Date
August 1 2006
End Date
December 1 2009
Last Update
September 25 2017
Active Locations (7)
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1
Whitman-Walker Clinic
Washington D.C., District of Columbia, United States, 20009
2
CARE-ID
Washington D.C., District of Columbia, United States, 20037
3
Steinhart Medical Associates
Miami, Florida, United States, 33133
4
Orlando Immunology Center
Orlando, Florida, United States, 32803