A 96 week study comparing the standard dose (600mg) to the reduced dose (400mg) efavirenz with the combination of Truvada for HIV-infected participants who have not taken any anti-HIV medication.

• Conditions: Human Immunodeficiency Virus infection; MedDRA version: 14.1Level: LLTClassification code 10070257Term: Human immunodeficiency virus test positiveSystem Organ Class: 10022891 - Investigations; MedDRA version: 14.1Level: PTClassification code 10020161Term: HIV infectionSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2009-013795-44-DE
• Lead Sponsor: The Kirby Institute (formerly National Centre in HIV Epidemiology and Clinical Research (NCHECR)), University of New Sou

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-04-08
• Last Update Posted: 10 June 2013

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 630

Inclusion Criteria

• HIV-1 positive by licensed diagnostic test
• aged >16 years of age (or minimum age as determined by local regulations or as legal requirements dictate)
• 50 < CD4 <500 cells/µL
•No prior AIDS-defining illness, using the CDC 1993 case definition (except pulmonary tuberculosis)
• HIV RNA =1000 copies/mL
• no prior exposure to ART (including short course ARVs for preventing MTCT)
• calculated creatinine clearance (CLCr) = 50 mL/min (Cockcroft-Gault formula)
• provision of written informed consent.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 630
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 630

Exclusion Criteria

• the following laboratory values:
- absolute neutrophil count (ANC) <500 cells/µL
- hemoglobin <7.0 g/dL
- platelet count <50,000 cells/µL
- AST and/or ALT >5 x ULN
• pregnant women or nursing mothers
• active opportunistic or malignant disease not under adequate control
• use of immunomodulators within 30 days prior to screening
• use of any prohibited medications
• current alcohol or illicit substance use that might adversely affect study participation.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To compare the safety and efficacy of standard (600mg qd) versus reduced dose (400mg qd) EFV as part of initial combination antiretroviral therapy (ART).;Secondary Objective: To conduct a range of analyses to examine:<br>• Virological response to therapy<br>• Changes in CD4+ T cell numbers<br>• Incidence and type of SAEs<br>• Incidence and type of AEs<br>• Changes from baseline in fasted lipid, glucose and selected serum biochemical parameters <br>• Adherence to therapy<br>• Quality of life<br>• Neurocognitive function<br>• Dry Blood Spot to measure viral loads<br>• Measurement of EFV concentration in dried blood spot and plasma samples<br>;Primary end point(s): The primary endpoint is the comparison between treatment groups of proportions of patients with HIV RNA <200 copies/mL 48 weeks after randomisation. ;Timepoint(s) of evaluation of this end point: 48 weeks