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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

636 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2014-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Study Of Different Doses Of UK-453, 061 Plus Truvada Compared To Efavirenz Plus Truvada In Patients Who Have Not Been Previously Treated For HIV-1

NCT00824421

HIV-1

COMPLETED PHASE2

Efavirenz 400mg in Treatment-naïve Chinese HIV-infected Patients

NCT04596488

HIV-1-infection

COMPLETED NA

Tenofovir Disoproxil Fumarate/Emtricitabine/Efavirenz Versus Combivir/Efavirenz in Antiretroviral-Naive HIV-1 Infected Subjects

NCT00112047

HIV Infections

COMPLETED PHASE3

Efavirenz (EFV) Intensification

NCT07193875

HIV

COMPLETED PHASE4

SSAT063- Pharmacokinetics of Efavirenz 400 mg Once Daily During Pregnancy in HIV-1 Infected Women

NCT02499874

HIV

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

In this international, multicenter trial, 630 HIV infected patients who have not received any previous treatment for their HIV-infection will be enrolled. Participants will be randomized equally (1:1) to receive Truvada (tenofovir and emtricitabine) with either the standard or reduced dose of EFV. Neither the study doctor nor the participant will know which treatment the participant is receiving. Physical examinations, laboratory analyses and questionnaires will be performed at the 11 study visits at screening, baseline (Week 0), Weeks 4, 12, 24, 36, 48, 60, 72, 84 and 96. The primary aim of this study is to compare between treatment groups the proportion of patients with undetectable HIV viral load (HIV RNA \< 200 copies/mL) after 48 weeks. Information on immune function, drug adherence, resistance to antiretrovirals, quality of life, mental state and HIV-related conditions will also be collected. Blood samples will be collected for future testing. Interim analyses will be performed when the first 125 participants in each treatment group reach week 24 and when all participants reach week 24. These interim analyses will provide an early check that the reduced dose of EFV suppresses HIV infection as effectively as the standard dose of EFV. A follow-up analysis will be performed when all participants reach week 96.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

HIV Infections

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

600 milligram (mg) Efavirenz

Eligible patients will be centrally randomised to receive tenofovir (TDF) (300mg qd)/emtricitabine (FTC) (200mg qd) + EFV (600mg qd; 3 x 200mg qd)

Group Type ACTIVE_COMPARATOR

Efavirenz 600mg

Intervention Type DRUG

3 x EFV 200 milligram (mg) tablets once daily

400mg Efavirenz

Eligible patients will be centrally randomised to receive TDF (300mg qd)/FTC (200mg qd) + EFV (400mg qd; 2 x 200mg + 1 x 200mg placebo qd).

Group Type EXPERIMENTAL

Efavirenz 400mg

Intervention Type DRUG

2 x EFV 200 milligram (mg) tablets plus 1x matched EFV placebo tablet once daily

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Efavirenz 600mg

3 x EFV 200 milligram (mg) tablets once daily

Intervention Type DRUG

Efavirenz 400mg

2 x EFV 200 milligram (mg) tablets plus 1x matched EFV placebo tablet once daily

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Matrix EFV 200mg tablets Matrix EFV 200mg tablets Matrix EFV 200mg matched placebo tablets.

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No