NCT04746547 (ORCHID) is a Phase 4 clinical trial of Dolutegravir 50 MG in Tuberculosis, sponsored by University of KwaZulu.

Who is sponsoring NCT04746547?

NCT04746547 is sponsored by University of KwaZulu.

What drugs are being tested in NCT04746547?

Interventions in NCT04746547: Dolutegravir 50 MG, Dolutegravir 10 MG.

What condition does NCT04746547 study?

NCT04746547 studies Tuberculosis, Hiv.

Is NCT04746547 still recruiting?

NCT04746547 is currently status unknown. Last updated 1 February 2024.

Last reviewed 2024-02-01 · How we verify

NCT04746547: ORCHID

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

Pharmacokinetics of Twice or Once Daily DTG (50mg) in Children With HIV and TB

Status unknown Phase 4 Last updated 1 February 2024

What this trial tests

Phase 4 trial testing Dolutegravir 50 MG in Tuberculosis in 20 participants. Status unknown.

Timeline

19 August 2021

Primary endpoint
31 July 2025

31 July 2025

Quick facts

Lead sponsor	University of KwaZulu
Phase	Phase 4
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	20
Start date	19 August 2021
Primary completion	31 July 2025
Estimated completion	31 July 2025
Sites	1 location across South Africa

Drugs / interventions tested

Dolutegravir 50 MG — full drug profile →
Dolutegravir 10 MG — full drug profile →

Conditions studied

Tuberculosis — all drugs for Tuberculosis →
Hiv — all drugs for Hiv →

Sponsor

University of KwaZulu

Who can join

Adults 23 Months to 18, any sex, with Tuberculosis or Hiv. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Stage 1 proposed study will provide evidence to support the use of twice-daily dose 50mg DTG in children (20-35kgs) co-treated with RIF. Note: An amendment has been added to include children from 3kgs and a dose of 10mg dispersible DTG

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Pharmacokinetics and safety of dolutegravir in children receiving rifampicin tuberculosis treatment in South Africa (ORCHID): a prospective cohort study.
Naidoo A, Waalewijn H, Naidoo K, Letsoalo M, et al · · 2025 · cited 2× · PMID 40023169 · DOI 10.1016/s2352-3018(24)00312-6

Verify or expand the search:

Other trials of Dolutegravir 50 MG

Trials testing the same drug.

NCT04340388 — Contribution of Dolutegravir to Obesity and Cardiovascular Disease · Phase 4 · completed
NCT04638686 — REal-Life Cohort With DOlutegravir + LAmivudina · completed
NCT05351684 — Effect of Dolutegravir Intensification on HIV-1 Reservoirs · Phase 2 · completed
NCT03512964 — Rapid HIV Treatment Initiation, Access and Engagement in Care · NA · completed

Other recruiting trials for Tuberculosis

Currently open trials in the same condition.

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NCT07170735 — Quantitative Measurement of Plasma and Urine MTB Cell-free DNA Level · recruiting
NCT07484490 — Effects of the Active Cycle of Breathing Technique With and Without Balloon Blowing Therapy in Tuberculosis · NA · recruiting
NCT06318416 — Precision Rifampin Trial for Personalized Dosing · Phase 1 · recruiting
NCT07170800 — A Phase 2b Clinical Study of JDB0131 Benzenesulfonate Tablets · Phase 2 · recruiting

Other University of KwaZulu trials

Trials by the same sponsor.

NCT07339462 — Feasibility and Acceptability of an Intervention to Support People With Severe Mental Illness in South Africa · NA · recruiting
NCT06516549 — Evaluation of Skipping Rope and Informational Pamphlet Among Adolescents in South Africa · NA · recruiting
NCT06429475 — Anti-Inflammatory Reliever South Africa · Phase 3 · recruiting
NCT06248190 — ENHANCE-EvideNce Led Co-created HeAlth Systems interventioNs for MLTCs CarE · NA · completed
NCT05061407 — An African, Multi-centre Evaluation of Patient Care and Clinical Outcomes for Paediatric Patients Undergoing Surgery · completed

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 NCT04746547 (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 of KwaZulu
Last refreshed: 1 February 2024

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/NCT04746547.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing