A Phase 4 interventional study of EFV+TDF and EFV+3TC+TDF in HIV Infections, sponsored by Gilead Sciences. Completed at 1 site in France. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2008-06-30.
Sponsored by Gilead Sciences · Phase 4 and Interventional
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 the two arms for genotypic resistance profile in case of virological failure
CD4 changes from baseline
Evolution of the lipid profile and morphological changes in fat distribution, and safety
Efficacy and genotypic profile data, results of lipid markers, morphological changes and main biological parameters
4,258 studies on the registry are indexed under HIV Infections; 240 are open to participants now.
This study's enrollment of 140 is above the median of 83 across 3,251 interventional studies indexed under HIV Infections.
Browse HIV Infections studies →Gilead Sciences is the lead sponsor of 680 studies on the registry; 24 are open to participants now.
Of its 259 completed or terminated interventional studies of FDA-regulated products, 249 (96%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
TDF+EFV
Drug: EFV+TDF
TDF+3TC+EFV
Drug: EFV+3TC+TDF
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)
Time frame: 48 wks
Comparison of the two arms for genotypic resistance profile in case of virological failure
Time frame: 48 wks
CD4 changes from baseline
Time frame: 48 wks
Evolution of the lipid profile and morphological changes in fat distribution, and safety
Time frame: 48 wks
This study is completed, as verified in Jun 2008. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Gilead Sciences