Safety and Efficacy of Reduced Versus Standard Dose Efavirenz (EFV) Plus Two Nucleotides in Antiretroviral-naïve Adults.

• Status: Completed
• Trial end date: 2014-08-01
• Target enrollment: 0
• Participant gender: All

Summary

Clinical data suggests that the standard dose of the anti-HIV medication, efavirenz (EFV), could be reduced without compromising its effectiveness. Lower drug doses could have fewer side effects and would make EFV more affordable. The purpose of this study is to compare the safety and effectiveness, over 96 weeks, of standard (600mg) versus reduced dose (400mg) EFV in controlling HIV as part of initial combination antiretroviral therapy.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kirby Institute
• Treatments: Efavirenz; Reverse Transcriptase Inhibitors

Criteria

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 < cluster of differentiation (CD)4 <500 cells/µL

• No prior AIDS-defining illness, using the Center for Diseases Control 1993 Case Definition (except pulmonary tuberculosis)

• HIV RNA ≥1000 copies/mL

• no prior exposure to antiretroviral therapy (ART) (including short course ART for preventing MTCT)

• calculated creatinine clearance (CLCr) more than or equal to 50 mL/min (Cockcroft-Gault formula)

• provision of written informed consent.

Exclusion Criteria:

• the following laboratory values:

• absolute neutrophil count (ANC) <500 cells/μL

• hemoglobin <7.0 g/dL

• platelet count <50,000 cells/μL

• alanine aminotransferase and/or aspartate aminotransferase >5 x upper limit of normal

• 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