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

Peking Union Medical College Hospital25 enrolled

Overview

Evaluating the efficacy, pharmacodynamics, and safety of Efavirenz 400mg in treatment-naïve Chinese HIV-infected patients.

Treatment-naive HIV-infected patients are designed to enroll and receive efavirenz 400mg combined with tenofovir (TDF) and lamivudine (3TC) as initial antiretroviral regimens, and monitoring for 48 weeks, to evaluate efavirenz concentration, T-cell subsets, HIV RNA load, and neuropsychiatric tests with Hamilton depression scale (HAMD) and Pittsburgh sleep quality index (PSQI) at baseline, 4, 12, 24, 48 weeks.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

HIV-1-infection

Interventions

Efavirenz 400mgDRUG

HIV-infected patients were treated with efavirenz 400mg combined with tenofovir 300mg and lamivudine 300mg.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * (1) HIV treatment-naïve, (2) age between 18 years or older, (3) be willing to complete the HAMD and PSQI scale and follow-up regularly, (5) not participating in other studies. Exclusion Criteria: * (1) acute HIV-1-infected patients, (2) an AIDS-defining illness such as pneumocystis pneumonia, tuberculosis within 2 weeks of entry, (3) transaminase and alkaline phosphatase levels beyond three times the upper limit of the normal range, bilirubin level more than 2.5 times the upper limit of the normal range, and serum creatinine level excess 1.5 times the upper limit of the normal range, (4) pregnancy or breast feeding

Locations (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Outcomes

Primary Outcomes

Viral suppression

The proportion of patients with viral load less than 50 copies/mL

Time frame: 48 weeks

Secondary Outcomes

Drug concentration

The proportion of patients with plasma efavirenz concentration between 1 mg/L and 4mg/L

Time frame: 48 weeks

Neuropsychiatric adverse events

The proportion of patients with HAMD \<8 and PSQI \<10 (less neuropsychiatric adverse effects)

Time frame: 48 weeks

Data from ClinicalTrials.gov

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