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

Summary

SaDAPT is a pragmatic, randomized, therapeutic-use trial comparing two approaches ("ART first" versus "TB results first") for the timing of ART initiation in PLHIV with presumptive TB, but no signs of central nervous system (CNS) disease, in a routine primary and secondary care setting in southern Africa with regard to HIV viral suppression (VL \<400 copies/mL) 26 weeks after enrolment.

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.

Sponsors & Collaborators

• Swiss National Science Foundation

  collaborator OTHER

• SolidarMed

  collaborator OTHER

• Kamuzu University of Health Sciences, Malawi

  collaborator UNKNOWN

• Swiss Tropical & Public Health Institute

  collaborator OTHER

• Malawi-Liverpool-Wellcome Trust Clinical Research Programme

  collaborator OTHER

• London School of Hygiene and Tropical Medicine

  collaborator OTHER

• University Hospital, Basel, Switzerland

  lead OTHER

Principal Investigators

• Niklaus Labhardt, Prof. Dr. DTM&H, MIH · Division of Clinical Epidemiology, University Hospital Basel

• Rachael Mary Burke, BMBCh, MSc, DTM&H · London School of Hygiene and Tropical Medicine

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

12 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-10-19

Primary Completion

2024-11-26

Completion

2025-01-14

Countries

• Lesotho
• Malawi

Study Locations