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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

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

Condition or disease Intervention/treatment Phase
HIV-1-infection Drug: Efavirenz 400mg Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pharmacodynamics of Efavirenz 400mg in Treatment-naïve Chinese HIV-infected Patients in a Prospective Cohort Study
Actual Study Start Date : June 1, 2017
Actual Primary Completion Date : December 30, 2018
Actual Study Completion Date : December 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
Drug Information available for: Efavirenz

Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Viral suppression [ Time Frame: 48 weeks ]
    The proportion of patients with viral load less than 50 copies/mL


Secondary Outcome Measures :
  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)


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04596488


Locations
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China, Beijing
Peking Union Medical College Hospital
Beijing, Beijing, China, 100730
Sponsors and Collaborators
Peking Union Medical College Hospital
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
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Principal Investigator: Taisheng Li, MD, PhD Peking Union Medical College Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: LI Taisheng, Director in department of Infectious Diseases, Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT04596488    
Other Study ID Numbers: XL001
First Posted: October 22, 2020    Key Record Dates
Last Update Posted: October 23, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by LI Taisheng, Peking Union Medical College Hospital:
Efavirenz 400mg
Chinese HIV-infected patients
Additional relevant MeSH terms:
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Efavirenz
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
 Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Cytochrome P-450 CYP2C19 Inhibitors
Cytochrome P-450 CYP2B6 Inducers
Cytochrome P-450 Enzyme Inducers
Cytochrome P-450 CYP3A Inducers