efficacy of 400 mg efavirenz versus standard 600 mg dose in hiv/tb co-infected patients

Conditions: HIV Infections; Tuberculosis

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 criteria:
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 * 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.