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

Chinese Academy of Medical Sciences & Peking Union Medical College

Status: Completed

Conditions: HIV-1-infection

Treatments: Drug: Efavirenz 400mg

Study type: Interventional

Funder types: Other

Identifiers

NCT04596488

XL001

Details and patient eligibility

About

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

Full description

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.

Enrollment: 25 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

25 participants in 1 patient group

Efavirenz 400mg+TDF+3TC

Experimental group

Description:

Combined antiretroviral therapy(cART) consisting of three regimens such as efavirenz, tenofovir and lamivudine is an effective measure for the treatment of HIV-1 infection.Efavirenz 600mg daily was approved by the US Food and Drug Administration in 1998. In this single-arm research, patients were treated with a reduced 400mg dose of efavirenz combined with tenofovir 300mg and lamivudine 300mg once a day. This treatment had to be maintained indefinitely due to the existence of HIV reservoir.

Treatment:

Drug: Efavirenz 400mg