Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT04596488
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04596488
Recruitment Status : Completed
First Posted : October 22, 2020
Last Update Posted : October 23, 2020
Sponsor:
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
Information provided by (Responsible Party):
LI Taisheng, Peking Union Medical College Hospital

Tracking Information
First Submitted Date  ICMJE October 15, 2020
First Posted Date  ICMJE October 22, 2020
Last Update Posted Date October 23, 2020
Actual Study Start Date  ICMJE June 1, 2017
Actual Primary Completion Date December 30, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 21, 2020)
Viral suppression [ Time Frame: 48 weeks ]
The proportion of patients with viral load less than 50 copies/mL
Original Primary Outcome Measures  ICMJE
 (submitted: October 15, 2020)
Viral suppression [ Time Frame: 48 weeks ]
The propotion of patients with viral load less than 50 copies/mL
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 21, 2020)
  • Drug concentration [ Time Frame: 48 weeks ]
    The proportion of patients with plasma efavirenz concentration between 1 mg/L and 4mg/L
  • Neuropsychiatric adverse events [ Time Frame: 48 weeks ]
    The proportion of patients with HAMD <8 and PSQI <10 (less neuropsychiatric adverse effects)
Original Secondary Outcome Measures  ICMJE
 (submitted: October 15, 2020)
  • Drug concentration [ Time Frame: 48 weeks ]
    The propotion of patients with plasma efavirenz concentration between 1 mg/L and 4mg/L
  • Neuropsychiatric adverse events [ Time Frame: 48 weeks ]
    The propotion of patients with HAMD <8 and PSQI <10 (less neuropsychiatric adverse effects)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efavirenz 400mg in Treatment-naïve Chinese HIV-infected Patients
Official Title  ICMJE Pharmacodynamics of Efavirenz 400mg in Treatment-naïve Chinese HIV-infected Patients in a Prospective Cohort Study
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE HIV-1-infection
Intervention  ICMJE Drug: Efavirenz 400mg
HIV-infected patients were treated with efavirenz 400mg combined with tenofovir 300mg and lamivudine 300mg.
Study Arms  ICMJE 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.
Intervention: Drug: Efavirenz 400mg
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-naïve 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 15, 2020)
25
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 30, 2019
Actual Primary Completion Date December 30, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04596488
Other Study ID Numbers  ICMJE XL001
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party LI Taisheng, Peking Union Medical College Hospital
Study Sponsor  ICMJE Peking Union Medical College Hospital
Collaborators  ICMJE
  • 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
Investigators  ICMJE
Principal Investigator: Taisheng Li, MD, PhD Peking Union Medical College Hospital
PRS Account Peking Union Medical College Hospital
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP