A Phase 1b/2a Open Label Bridging Safety, Pharmacokinetics and Tolerability Studies on Chloroquine Based HREZ Combination Regimens in Adults with Pulmonary Tuberculosis - NI

Foundation for Neglected Disease Research0 个研究点目标入组 0 人开始时间: 待定最近更新: 2024年7月22日

试验速览

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•1) Adult male and female subjects aged 18 years and above with body weight between 30-65 kg.
•2) Individuals who are newly diagnosed with pulmonary tuberculosis through GeneXpert test. Individuals must be previously untreated and test positive for sputum GeneXpert.
•3) Subjects must be susceptible to rifampicin as detected by a cartridge-based nucleic acid amplification test.
•4) Willingness to undergo HIV testing.
•5) Subjects must have never been treated with multidrug anti tuberculosis therapy for more than a week.
•6) Willingness to attend the treatment center for supervised treatment and remain within the study area limit.
•7) Willingness to give blood samples for PK analysis on day 1 and day 14.
•8) Willingness to sign the informed consent form and adhere to study procedures and follow-up.
•9) Willingness to join the Directly Observed Treatment, Short-Course (DOTS) program
•10) Consent to home visits.

•1) Female subjects who are pregnant, breastfeeding, or planning to conceive during the study.
•2) Subjects with extra-pulmonary tuberculosis or drug-resistant tuberculosis (single drug resistance, H, or R).
•3) Subjects with a body weight less than 30 kg or greater than 65 kg.
•4) Subjects with a prior history of exposure to anti-tuberculosis treatment for more than a week.
•5) Subjects with a history of liver disease or current Alanine aminotransferase levels greater than three times the upper limit of normal or total bilirubin concentration exceeding the upper limit of normal.
•6) Subjects who test positive for hepatitis B virus surface antigen, hepatitis C virus antibody, and HIV.
•7) Subjects with concomitant psychiatric illness or a history of seizures.
•8) Anybody testing positive for malaria in the last two months prior to enrolment in the study.
•9) Diagnosed cases of extrapulmonary tuberculosis.
•10) Subjects who tested positive for COVID-19 with lung involvement.
•11) Subjects receiving treatment for rheumatoid arthritis (RA)/autoimmune disorders and CQ/hydroxy-CQ therapy.
•12) Subjects with malaria and Q-fever undergoing CQ/hydroxy-CQ therapy or have taken CQ/ hydroxy-CQ therapy 2 months prior to enrollment.

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