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

Pharmacodynamics of Efavirenz 400mg in Treatment-naïve Chinese HIV-infected Patients in a Prospective Cohort Study

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

Study Overview

• Status: Completed
• Conditions: HIV-1-infection
• Intervention / Treatment: Drug: Efavirenz 400mg

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 Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100730
      • Peking Union Medical College Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: Efavirenz 400mg+TDF+3TC; 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.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Viral suppression	The proportion of patients with viral load less than 50 copies/mL	48 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Peking Union Medical College Hospital
• Collaborators: National Key Technologies R&D Program for the 13th Five-year Plan; National Key Technologies R&D Program for the 12th Five-year Plan; CAMS Initiative for Innovative Medicine

Publications and helpful links

General Publications

• Xu L, Peng W, Song X, Li Y, Han Y, Zhu T, Fu Q, Du X, Cao W, Li T. Pharmacodynamics of efavirenz 400 mg in treatment-naive Chinese HIV-infected patients in a prospective cohort study. BMC Infect Dis. 2021 Jan 23;21(1):112. doi: 10.1186/s12879-021-05802-8. Erratum In: BMC Infect Dis. 2021 Feb 17;21(1):185.

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 1, 2017
• Primary Completion (ACTUAL): December 30, 2018
• Study Completion (ACTUAL): December 30, 2019

Study Registration Dates

• First Submitted: October 15, 2020
• First Submitted That Met QC Criteria: October 15, 2020
• First Posted (ACTUAL): October 22, 2020

Study Record Updates

• Last Update Posted (ACTUAL): October 23, 2020
• Last Update Submitted That Met QC Criteria: October 21, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: Efavirenz 400mg; Chinese HIV-infected patients
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Reverse Transcriptase Inhibitors; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Cytochrome P-450 Enzyme Inducers; Cytochrome P-450 CYP3A Inducers; Cytochrome P-450 CYP2B6 Inducers; Cytochrome P-450 CYP2C9 Inhibitors; Cytochrome P-450 CYP2C19 Inhibitors; Efavirenz
• Other Study ID Numbers: XL001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No