Status:
UNKNOWN
Efficacy of 400 mg Efavirenz Versus Standard 600 mg Dose in HIV/TB Co-infected Patients
Lead Sponsor:
Shanghai Public Health Clinical Center
Conditions:
HIV Infections
Tuberculosis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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
- Any evidence of primary viral resistance to Nucleoside reverse transcriptase inhibitor (NRTIs), Non-nucleoside reverse transcriptase inhibitor (NNRTIs) based on the presence of any major resistance-associated mutation in the Screening result or, if known, any historical resistance test result.
- Any acute laboratory abnormality at Screening, which, in the opinion of the investigator, would preclude the subject's participation in the study of an investigational compound.
Key Trial Info
Start Date :
November 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 31 2023
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT04513379
Start Date
November 1 2020
End Date
January 31 2023
Last Update
August 14 2020
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