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

Not Applicable

Completed

• Conditions: HIV-1-infection
• Interventions: Drug: Efavirenz 400mg

• Registration Number: NCT04596488
• Lead Sponsor: Peking Union Medical College Hospital

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2017-06-01
• Primary Completion: 2018-12-30
• Study Completion: 2019-12-30
• Status Verified: 2020-10
• Study First Submitted: 2020-10-15
• Study First Submitted QC: 2020-10-15
• Last Update Submitted: 2020-10-21
• Study First Posted: 2020-10-22
• Last Update Posted: 2020-10-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Efavirenz 400mg+TDF+3TC	Efavirenz 400mg	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.

Primary Outcome Measures

Name	Time	Method
Viral suppression	48 weeks	The proportion of patients with viral load less than 50 copies/mL

Secondary Outcome Measures

Name	Time	Method
Drug concentration	48 weeks	The proportion of patients with plasma efavirenz concentration between 1 mg/L and 4mg/L
Neuropsychiatric adverse events	48 weeks	The proportion of patients with HAMD \<8 and PSQI \<10 (less neuropsychiatric adverse effects)

Trial Locations

Locations (1)

Peking Union Medical College Hospital; 🇨🇳 Beijing, Beijing, China