Same-day Versus Rapid ART Initiation in HIV-positive Individuals Presenting With Symptoms of Tuberculosis

NACompletedINTERVENTIONAL
Enrollment

610

Participants

Timeline

Start Date

October 19, 2022

Primary Completion Date

November 26, 2024

Study Completion Date

January 14, 2025

Conditions
Human Immunodeficiency Virus (HIV) Infection
Interventions
OTHER

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.

OTHER

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.

Trial Locations (2)

Unknown

SolidarMed Lesotho, Premium House #224, Kingsway, Maseru West, Maseru

Kamuzu University of Health Sciences, Helse Nord Tuberculosis Initiative, Blantyre

All Listed Sponsors
collaborator

Swiss National Science Foundation

OTHER

collaborator

SolidarMed

OTHER

collaborator

Kamuzu University of Health Sciences, Malawi

UNKNOWN

collaborator

Swiss Tropical & Public Health Institute

OTHER

collaborator

Malawi-Liverpool-Wellcome Trust Clinical Research Programme

OTHER

collaborator

London School of Hygiene and Tropical Medicine

OTHER

lead

University Hospital, Basel, Switzerland

OTHER