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Completed

NCT Number: NCT04596488

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

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

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Key information

Conditions

HIV-1-infection

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Efavirenz 400mg

Drug

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

Primary outcomes

  1. Viral suppression

    Time frame: 48 weeks

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

Secondary outcomes

  1. Drug concentration

    Time frame: 48 weeks

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

  2. Neuropsychiatric adverse events

    Time frame: 48 weeks

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

Sponsors and collaborators

Lead sponsor

Peking Union Medical College Hospital

Other

Collaborators

  • 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

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Oct 22, 2020
Registry last updated
Oct 23, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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