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UNKNOWNPHASE3

Efficacy of 400 mg Efavirenz Versus Standard 600 mg Dose in HIV/TB Co-infected Patients

Efficacy and Safety of 400 mg Efavirenz Versus Standard 600 mg Dose in HIV/TB Co-infected Patients Receiving Rifampicin Based Anti-TB Therapy

NCT04513379•Shanghai Public Health Clinical Center

View on ClinicalTrials.gov

Summary

TB is the most common cause of death in patients with HIV worldwide. Rifampicin \[RIF\] is the cornerstone of anti-TB therapy. Current guideline recommend efavirenz (EFV) 600mg per day as the first of choice for HIV/TB co-infection. Co-administration of EFV with RIF decrease the plasma concentration of EFV. Because of better safety profiles, EFV 400mg has replaced the EFV 600mg as the first-line antiretroviral therapy in people living with HIV. However, the efficacy of EFV 400mg when co-administrated with RIF in HIV/TB co-infection is unclear. This study is designed to evaluate the efficacy and safety of EFV 400mg versus EFV 600mg in HIV/TB co-infected patients receiving RIF based anti-TB therapy.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Subject or the subject's legal representative is willing and able to understand and provide signed and dated written informed consent prior to Screening
•Adult subject (at least 18 years of age)
•Naive to antiretroviral therapy (\<=14 days of prior therapy with any antiretroviral drug following a diagnosis of HIV-1 infection)
•CD4+ cell count is \>= 50 cells/ cubic millimetre (mm\^3) at Screening
•A female subject may be eligible to enter and participate in the study if she: is of non-childbearing potential defined as either postmenopausal (12 months of spontaneous amenorrhea and \>=45 years of age) or physically incapable of becoming pregnant or does not want to pregnancy
•New diagnosis of TB (microbiology or molecular methods or clinical diagnosis) and started rifampicin based regimen for less no longer than 8 weeks at screening

Exclusion Criteria

•Evidence of RIF resistance of Mycobacterium tuberculosis either by culture or validated nucleic acid amplification test
•Concomitant disorders or conditions for which isoniazid, RIF, pyrazinamide, or ethambutol are contraindicated
•Central nervous system TB
•Women who are pregnant or breastfeeding
•Subjects with moderate to severe hepatic impairment (Class B or C) as determined by Child-Pugh classification unstable liver disease
•Anticipated need for hepatitis C virus (HCV) therapy during the study period
•History or presence of allergy or intolerance to the study drugs or their components or drugs of their class
•Subjects who, in the investigator's judgment, pose a significant suicidality risk.
•Treatment with any of the following agents within 28 days of Screening: radiation therapy, cytotoxic chemotherapeutic agents, any immunomodulators that alter immune response
•Exposure to an experimental drug or experimental vaccine within either 28 days, 5 half-lives of the test agent, or twice the duration of the biological effect of the test agent, whichever is longer, prior to the first dose of investigate drug
+2 more criteria

Key Dates

Start Date

November 1, 2020

Primary Completion Date

October 30, 2022

Completion Date

January 31, 2023

Last Updated

August 14, 2020

Enrollment

ESTIMATED participants

Conditions

HIV InfectionsTuberculosis

Interventions

Efavirenz 600mg

DRUG

Efavirenz 400mg

DRUG

Contacts

Jun Chen, M.D

CONTACT

+86-21-37990333 qtchenjun@163.com

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RECRUITINGNA

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 14, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Efficacy of 400 mg Efavirenz Versus Standard 600 mg Dose in HIV/TB Co-infected Patients

Inclusion Criteria

Exclusion Criteria

Trial of Novel Regimens for the Treatment of Pulmonary Tuberculosis

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