610
Participants
Start Date
October 19, 2022
Primary Completion Date
November 26, 2024
Study Completion Date
January 14, 2025
ART first- Therapeutic use trial
ART initiation on the day of enrolment independent of TB investigations in PLHIV with presumptive TB but no signs of CNS disease. The trial uses treatments and drug-doses as per international and national guidelines. All treatment components will be applied at standard dosage and no new substances or alternative indications will be tested.
TB results first- Therapeutic use trial
Deferral of ART initiation until active TB has been refuted or confirmed. PLHIV presenting with symptoms (cough, fever, night sweat, weight loss) are defined as presumptive TB, and should have microbiological TB investigations. Routine TB investigations in Malawi and Lesotho usually consist of two sputum bottles for analysis using nucleic acid amplification tests (Xpert MTB/RIF (Ultra)).The trial uses treatments and drug-doses as per international and national guidelines. All treatment components will be applied at standard dosage and no new substances or alternative indications will be tested.
SolidarMed Lesotho, Premium House #224, Kingsway, Maseru West, Maseru
Kamuzu University of Health Sciences, Helse Nord Tuberculosis Initiative, Blantyre
Swiss National Science Foundation
OTHER
SolidarMed
OTHER
Kamuzu University of Health Sciences, Malawi
UNKNOWN
Swiss Tropical & Public Health Institute
OTHER
Malawi-Liverpool-Wellcome Trust Clinical Research Programme
OTHER
London School of Hygiene and Tropical Medicine
OTHER
University Hospital, Basel, Switzerland
OTHER