Who is sponsoring NCT05452616?

NCT05452616 is sponsored by University Hospital, Basel, Switzerland.

What drugs are being tested in NCT05452616?

Interventions in NCT05452616: ART first- Therapeutic use trial, TB results first- Therapeutic use trial.

What condition does NCT05452616 study?

NCT05452616 studies Human Immunodeficiency Virus (HIV) Infection.

Is NCT05452616 still recruiting?

NCT05452616 is currently completed. Last updated 4 April 2025.

Last reviewed 2025-04-04 · How we verify

NCT05452616: SaDAPT

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed NA Last updated 4 April 2025

What this trial tests

NA trial testing ART first- Therapeutic use trial in Human Immunodeficiency Virus (HIV) Infection in 610 participants. Completed in 14 January 2025.

Timeline

19 October 2022

Primary endpoint
26 November 2024

14 January 2025

Quick facts

Lead sponsor	University Hospital, Basel, Switzerland
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	610
Start date	19 October 2022
Primary completion	26 November 2024
Estimated completion	14 January 2025
Sites	2 locations across Malawi, Lesotho

Drugs / interventions tested

ART first- Therapeutic use trial
TB results first- Therapeutic use trial

Conditions studied

Human Immunodeficiency Virus (HIV) Infection — all drugs for Human Immunodeficiency Virus (HIV) Infection →

Sponsor

University Hospital, Basel, Switzerland

Who can join

12 and older, any sex, with Human Immunodeficiency Virus (HIV) Infection. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

Same-day versus rapid ART initiation in HIV-positive individuals presenting with symptoms of tuberculosis: Protocol for an open-label randomized non-inferiority trial in Lesotho and Malawi.
Gerber F, Semphere R, Lukau B, Mahlatsi P, et al · · 2024 · cited 3× · PMID 38330045 · DOI 10.1371/journal.pone.0288944
Same-day versus rapid ART initiation in people with HIV and symptoms of tuberculosis (SaDAPT): a randomised, non-inferiority trial in Lesotho and Malawi.
Gerber F, Semphere R, Lukau B, Mahlatsi P, et al · · 2026 · cited 1× · PMID 41692011 · DOI 10.1016/s2352-3018(25)00276-0
Abstract Supplement Abstracts from IAS 2025, the 13th IAS Conference on HIV Science, 13 - 17 July, Kigali, Rwanda & Virtual.
· 2025 · PMID 40657994 · DOI 10.1002/jia2.26518
Same-day versus rapid ART initiation in HIV-positive individuals presenting with symptoms of tuberculosis: protocol for an open-label randomized non-inferiority trial in Lesotho and Malawi
Gerber F, Semphere R, Lukau B, Mahlatsi P, et al · · 2023 · DOI 10.1101/2023.07.10.23292457

Verify or expand the search:

Other recruiting trials for Human Immunodeficiency Virus (HIV) Infection

Currently open trials in the same condition.

NCT07209917 — Secondary Cervical Cancer Prevention of Vulnerable Women With HPV and HIV Co-infection in India · NA · recruiting
NCT06886971 — Strategies to AchieVe Viral Suppression for Youth With HIV · NA · recruiting
NCT04375800 — Doravirine (DOR) in Human Immunodeficiency Virus (HIV)-Infected Children Aged 4 Weeks to <12 Years and <45 kg (MK-1439-0 · Phase 2 · recruiting

Other University Hospital, Basel, Switzerland trials

Trials by the same sponsor.

NCT07444788 — Acute Effects of Intravenous 5-MeO-DMT in Healthy Participants · Phase 1 · recruiting
NCT07494214 — Acute Analgesic Effects of MDMA on Experimentally Induced Acute Pain, Hyperalgesia and Allodynia in Healthy Participants · Phase 1 · recruiting
NCT07419048 — Artificial Intelligence or Human Hand? Evaluating Inferior Vena Cava Imaging for Hydration Status · recruiting
NCT06978777 — Effect of Caffeine on Cold-stimulated Brown Adipose Tissue Activity · NA · recruiting
NCT07273630 — Effect of Protein Supplementation and Fluid Restriction on Plasma Sodium Levels in Patients Undergoing Pituitary Surgery · NA · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05452616 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University Hospital, Basel, Switzerland
Last refreshed: 4 April 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05452616.

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