NCT04463784

Peking Union Medical College Hospital

Status unknown NA Last updated 3 July 2020

What this trial tests

NA trial testing Efavirenz 400Mg Oral Tablet in HIV/AIDS in 500 participants. Status unknown.

Timeline

1 April 2018

Primary endpoint
1 December 2020

1 August 2021

Quick facts

Lead sponsor	Peking Union Medical College Hospital
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	500
Start date	1 April 2018
Primary completion	1 December 2020
Estimated completion	1 August 2021
Sites	1 location across China

Drugs / interventions tested

• Efavirenz 400Mg Oral Tablet — full drug profile →
• Efavirenz 600Mg Oral Tablet — full drug profile →

Conditions studied

• HIV/AIDS — all drugs for HIV/AIDS →
• Mental Impairment — all drugs for Mental Impairment →

Sponsor

Peking Union Medical College Hospital

Who can join

Adults 18 to 65, any sex, with HIV/AIDS or Mental Impairment. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Change from Baseline Virological measurements at 12 weeks
  Time frame: 12 weeks
  Plasma viral load
• Change from Baseline Virological measurements at 24 weeks
  Time frame: 24 weeks
  Plasma viral load
• Change from Baseline Virological measurements at 48 weeks
  Time frame: 48 weeks
  Plasma viral load
• Change from Baseline Virological measurements at 72 weeks
  Time frame: 72 weeks
  Plasma viral load
• Change from Baseline Virological measurements at 96 weeks
  Time frame: 96 weeks
  Plasma viral load
• Change from Baseline Immunological measurements at 12 weeks
  Time frame: 12 weeks
  CD4 T cell count

Sponsor's own description

The present study will be a randomized controlled study in which 500 treatment-naive HIV patients will be randomized 1:1 to Efaviren 400mg v.s. 600mg combined with lamivudine and tenofovir. The whole cohort will be followed for two years. Efficacy and safety of each regimen will be evaluated throughout the study.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Efavirenz 400 mg vs. 600 mg Combined with Lamivudine and Tenofovir in Treatment-Naïve HIV-Infected Patients in China: A Randomized, Multi-Centered, Controlled Trial.
   Hang Q, Ziyan W, Xiaojing S, Min W, et al · · 2026 · PMID 42235914 · DOI 10.1016/j.ijid.2026.108859