Phase 3
Completed N=636
Safety and Efficacy of Reduced Versus Standard Dose Efavirenz (EFV) Plus Two Nucleotides in Antiretroviral-naïve Adults.
Source: ClinicalTrials.gov NCT01011413 ↗Enrolled (actual)
636
Serious AEs
7.6%
Results posted
Feb 2020
Primary outcomePrimary: Percentage of Participants With Plasma HIV-1 RNA <200 Copies/mL 48 Weeks After Randomisation — 92.2; 94.1 percentage of participants — p=0.05
◆ Published Evidence
Highly cited
156citations · ~13 / year
Efficacy of 400 mg efavirenz versus standard 600 mg dose in HIV-infected, antiretroviral-naive adults (ENCORE1): a randomised, double-blind, placebo-controlled, non-inferiority trial.
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.
Linked Publications (3)
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Efficacy of 400 mg efavirenz versus standard 600 mg dose in HIV-infected, antiretroviral-naive adults (ENCORE1): a randomised, double-blind, placebo-controlled, non-inferiority trial.
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Efficacy and safety of efavirenz 400 mg daily versus 600 mg daily: 96-week data from the randomised, double-blind, placebo-controlled, non-inferiority ENCORE1 study.
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Cerebrospinal fluid exposure of efavirenz and its major metabolites when dosed at 400 mg and 600 mg once daily: a randomized controlled trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Plasma HIV-1 RNA <200 Copies/mL 48 Weeks After Randomisation |
92.2; 94.1 | 0.05 |
| SECONDARY Percentage of Participants With Plasma HIV-1 RNA <400 Copies/mL and <50 Copies/mL at 48 and 96 Weeks After Randomisation |
268; 277; 280; 291 | 0.05 |
| SECONDARY Mean Change From Baseline in CD4+ T-cell Count |
209; 235 | — |
| SECONDARY Clinical Endpoints: Opportunistic Disease or Death, and Serious Non-AIDS-defining Events and Non-AIDS-related Mortality |
7; 14; 2; 0; 5; 3 | — |
| SECONDARY Change From Baseline in Metabolic Endpoints |
0.62; 0.54; 0.35; 0.30; 0.21; 0.16 | — |
| SECONDARY Adherence: Median Scores of Self-reported Adherence to Randomised Study Medications |
256; 271; 7; 12; 1; 1 | — |
| SECONDARY Change From Baseline in Fasted Insulin Levels |
-0.11; 0.3 | — |
| SECONDARY Change in Selected Serum Biochemical Parameters |
6.53; 0.64; 1.71; -1.23; 26.75; 21.23 | — |
| SECONDARY Change From Baseline in Estimate Creatinine Clearance |
-0.17; 1.59 | — |
| SECONDARY Steady-state Efavirenz Concentrations |
2.85; 2.10 | — |
Eligibility 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 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
Data sourced from ClinicalTrials.gov (NCT01011413) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.