Status:
COMPLETED
TOTEM: Switch From Other Nucleoside Reverse Transcriptase Inhibitors (NRTIs) to Once Daily Truvada
Lead Sponsor:
Gilead Sciences
Conditions:
HIV Infections
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
This study looked at lipid changes in human immunodeficiency virus type 1 (HIV-1) infected patients when the nucleoside reverse transcriptase inhibitors (NRTIs) in their existing highly active antiret...
Detailed Description
This was a Phase IV, multicenter (in France), open label study. The study was conducted in two phases: a comparative randomized phase, which served the primary objective of the study, and a follow-up ...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Patients displaying abnormal fasted triglycerides (\> 2 g/L \[2.26 mmol/L\] and less than or equal to 10 g/L \[11.29 mmol/L\]) and/or fasted low density lipoprotein cholesterol (LDL-CHO; \> 1.6 g/L \[4.15 mmol/L\])
- Patients on stable HAART with 2 NRTIs + 1 NNRTI or 1 PI for at least 3 months prior to screening, and with plasma viral load \< 400 copies/mL for at least 6 months prior to screening
Exclusion
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2008
Estimated Enrollment :
92 Patients enrolled
Trial Details
Trial ID
NCT00323492
Start Date
September 1 2005
End Date
March 1 2008
Last Update
January 20 2010
Active Locations (1)
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1
Gilead Sciences
Paris, France, 75015