A Phase IV, Open-label, Prospective Observational Study to Evaluate Virological Response in Antiretroviral-Experienced HIV-1 infected Subjects Switching to Atripla (efavirenz/emtricitabine/tenofovir DF) on an Empty Stomach - ONCE - Only Nocturnal Combination Evaluation

Gilead Sciences Limited0 sitesMarch 19, 2008

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Antiretroviral-experienced HIV 1 infected subjects on their first and stable HAART regimen of efavirenz, emtricitabine, and tenofovir DF.
Sponsor: Gilead Sciences Limited
Status: Active, not recruiting
Last Updated: 14 years ago

No summary available.

Registry

who.int

Start Date

March 19, 2008

End Date

TBD

Last Updated

14 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

Gilead Sciences Limited

•Subjects must have documented HIV\-1 infection by Roche Amplicor® (Version 1\.5
•Ultra\-sensitive) or equivalent assay – either at screening or previously documented in the patient’s medical record.
•Stable HAART regimen of efavirenz, emtricitabine and tenofovir DF or Truvada and
•efavirenz for \= 24 weeks prior to Screening. (Subjects can have been previously treated with tenofovir DF, lamivudine, and efavirenz or tenofovir DF, emtricitabine, and efavirenz prior to switching to Truvada and efavirenz. They must have switched in order to simplify his/her HAART regimen and must not have had a treatment interruption prior to the switch).
•Undetectable plasma HIV\-1 RNA (\< 50 copies/mL) at Screening and \=12 weeks prior to Screening).
•\=18 years old
•Adequate renal function by:
•\- Estimated creatinine clearance \=60 mL/min according to the Cockcroft Gault formula
•Hepatic transaminases (AST and ALT) \= 5 x upper limit of normal (ULN)
•Total bilirubin \= 1\.5 mg/dL

•Subjects who have been treated with any ARV other than Truvada, tenofovir DF,
•emtricitabine, lamivudine or efavirenz
•Known hypersensitivity or toxicities to emtricitabine (FTC), tenofovir DF (TDF) or
•Known hypersensitivity or toxicities to lamivudine (3TC) if the subject initiated HAART with tenofovir DF, lamivudine, and efavirenz
•Known hypersensitivity or toxicities to Sustiva
•Have a history of resistance to any of the study agents at the time of screening (documented presence of resistance mutation(s) as defined by the IAS\-USA 2005 Guidelines
•A new AIDS\-defining condition diagnosed within the 30 days prior to the Baseline visit.
•Pregnant or lactating or breastfeeding females
•Severe hepatic impairment (\> 5 times upper limit of normal as defined by laboratory transaminases) or deemed clinically significant by investigator.
•Any current know clinical or laboratory parameter of GSI grade 4\. However asymptomatic grade 4 abnormalities will be permitted at the discretion of the investigator if deemed clinically appropriate (excluding AEs and laboratory parameters mentioned elsewhere in the inclusion/exclusion criteria). Abnormalities deemed insignificant by the investigator must be discussed with the sponsor prior to enrollment.