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NCT05630872
Pharmacokinetics and Safety of Double-dose Dolutegravir When Used With Rifapentine for HIV-associated Tuberculosis
Phase 2 trial testing Dolutegravir (DTG) 50 mg orally BID (~12 hours apart) plus TDF/3TC in HIV-associated Tuberculosis in 30 participants. Completed in 12 November 2025.
7 May 2025
Quick facts
| Lead sponsor | National Institute of Allergy and Infectious Diseases (NIAID) |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 30 |
| Start date | 13 February 2024 |
| Primary completion | 7 May 2025 |
| Estimated completion | 12 November 2025 |
| Sites | 4 locations across South Africa, Thailand |
Drugs / interventions tested
- Dolutegravir (DTG) 50 mg orally BID (~12 hours apart) plus TDF/3TC — full drug profile →
- DTG 50 mg orally QD plus TDF/3TC — full drug profile →
- 2HPZM — full drug profile →
- 2HPM — full drug profile →
Conditions studied
- HIV-associated Tuberculosis — all drugs for HIV-associated Tuberculosis →
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Who can join
18 and older, any sex, with HIV-associated Tuberculosis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
A5406 hypothesizes that dolutegravir (DTG) 50 mg taken twice daily will provide adequate exposures to maintain viral suppression when dosed with rifapentine (RPT) 1200 mg for HIV-associated TB.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT05630872
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other National Institute of Allergy and Infectious Diseases (NIAID) trials
Trials by the same sponsor.
- NCT07216794 — Small Trial of Alendronate Impact on the Reservoir of HIV · Phase 2 · not yet recruiting
- NCT07215858 — BPL-1357 Against H1N1 Influenza Virus Challenge · Phase 2 · recruiting
- NCT06987318 — A Study to Evaluate the Safety and Antiviral Activity of Two Human Monoclonal Antibodies (VRC07-523LS and PGT121.414.LS) · Phase 1 · not yet recruiting
- NCT07124559 — A Study of Daily Rifapentine Combined With Isoniazid (1HP) for Tuberculosis Prevention in Children Less Than 13 Years of · Phase 1, PHASE2 · not yet recruiting
- NCT07342491 — Dasatinib for HIV-1 Reservoir Reduction · Phase 1 · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05630872 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by National Institute of Allergy and Infectious Diseases (NIAID)
- Last refreshed: 8 December 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/NCT05630872.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing