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

HIV-1-infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04596488
• Other study ID #: XL001
• Status: Completed
• Phase: N/A
• Start date: June 1, 2017
• Est. completion date: December 30, 2019

Study information

• Verified date: October 2020
• Source: Peking Union Medical College Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: December 30, 2019
• Est. primary completion date: December 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• HIV-1-infection

Intervention

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

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing	Beijing

Sponsors (4)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital	CAMS Initiative for Innovative Medicine, National Key Technologies R&D Program for the 12th Five-year Plan, National Key Technologies R&D Program for the 13th Five-year Plan

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Viral suppression	The proportion of patients with viral load less than 50 copies/mL	48 weeks
Secondary	Drug concentration	The proportion of patients with plasma efavirenz concentration between 1 mg/L and 4mg/L	48 weeks
Secondary	Neuropsychiatric adverse events	The proportion of patients with HAMD <8 and PSQI <10 (less neuropsychiatric adverse effects)	48 weeks