A randomised, double-blind, placebo-controlled, clinical trial to compare the safety and efficacy of reduced dose efavirenz (EFV) with standard dose EFV plus two nucleotide reverse transcriptase inhibitors (N(t)RTI) in antiretroviral-naïve Human Immunodeficiency virus (HIV)-infected individuals over 96 weeks.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12610001097033

Acronym

Encore1

Enrollment

630

Registered

2010-12-15

Start date

2011-08-24

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The recommended dosage for some drugs currently used to treat HIV infection is highly effective but clinical data suggests that the doses could be reduced without compromising their effectiveness. Lower drug doses could have fewer side effects and could be tolerated better, making it easier for people to take and stay on their anti-HIV medication. Dose reduction would also make the drugs cheaper; this would allow more people to be treated and free up money for other important work in the fight against HIV such as education and prevention programs. Two different regimens containing either the standard dose or a reduced dose of efavirenz will be compared: I. efavirenz 600mg + truvada (tenofovir and emtricitabine) II. efavirenz 400mg + truvada (tenofovir and emtricitabine) Tenofovir, emtricitabine and efavirenz are all licensed as individual drugs for the treatment of HIV disease in many countries around the world. Efavirenz is only licensed at the standard dose of 600mg. Emtricitabine and tenofovir are provided as a fixed dose combination that is not currently licensed in every country involved in this study. A fixed dose combination means that the two drugs are incorporated into one pill.

Interventions

400mg Efavirenz plus 300 mg tenofovir and 200mg emtricitabine for 1 year once daily for each oral tablets

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

16 Years to No maximum

Healthy volunteers

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 <350 cells/microlitres or previous aquired immune deficiency syndrome-defining illness *HIV RNA greater than or equal to 1000 copies/mL *no prior exposure to antiretrovirals (including short course antiretrovirals for preventing mother to child transmission) *calculated creatinine clearance (CLCr) must be greater 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/microlitre *hemoglobin <7.0 g/dL *platelet count <50,000 cells/microlitre *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.

Outcome results