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NCT05118490: 1 to 3
Comparing Treatment Completion Of Daily Rifapentine & Isoniazid For One Month (1HP) To Weekly High Dose Rifapentine & Isoniazid For 3 Months (3HP) In Persons Living With HIV and in Household Contacts of Recently Diagnosed Tuberculosis Patients
Phase 4 trial testing Daily rifapentine and isoniazid for 4 weeks in HIV Seropositivity in 1,000 participants. Participants enrolled and being followed up; not accepting new ones.
11 July 2025
Quick facts
| Lead sponsor | The Aurum Institute NPC |
|---|---|
| Phase | Phase 4 |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | prevention |
| Enrollment | 1,000 |
| Start date | 19 July 2023 |
| Primary completion | 11 July 2025 |
| Estimated completion | 31 December 2025 |
| Sites | 4 locations across Mozambique, South Africa, Indonesia, India |
Drugs / interventions tested
- Daily rifapentine and isoniazid for 4 weeks — full drug profile →
- Weekly rifapentine and isoniazid for 12 weeks — full drug profile →
Conditions studied
- HIV Seropositivity — all drugs for HIV Seropositivity →
- Tuberculosis — all drugs for Tuberculosis →
- Household Contact — all drugs for Household Contact →
Sponsor
The Aurum Institute NPC
Who can join
13 and older, any sex, with HIV Seropositivity or Tuberculosis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
A multicenter, randomized, stratified, open-label, phase IV trial among HIV-positive persons (PLHIV) on antiretroviral therapy (ART), or HIV-negative household contacts of patients with rifampicin-sensitive pulmonary tuberculosis (TB), who do not have evidence of active TB.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Tuberculosis Preventive Treatment in High TB-Burden Settings: A State-of-the-Art Review.
Chihota V, Gombe M, Gupta A, Salazar-Austin N, et al · · 2025 · cited 15× · PMID 39733063 · DOI 10.1007/s40265-024-02131-3
Verify or expand the search:
- PubMed search for NCT05118490
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for HIV Seropositivity
Currently open trials in the same condition.
- NCT06799650 — Clinical Trial of Gammora® Plus Antiretroviral Treatment for HIV · Phase 2 · recruiting
- NCT05122026 — Safety and Tolerability of 1 Month Daily (1HP) and 3 Months Weekly (3HP) Isoniazid and Rifapentine With Pharmacokinetics · Phase 1, PHASE2 · active not recruiting
- NCT05723653 — Hybrid Type I Effectiveness-Implementation Trial of a Social Network Support Intervention · NA · recruiting
- NCT04832477 — Assessing the PrEP Care Cascade Among Black Men and Transwomen in the Southeastern US · NA · active not recruiting
Other The Aurum Institute NPC trials
Trials by the same sponsor.
- NCT06909799 — A Confirmatory Trial of Adjunctive NAC to Prevent Post Tuberculosis Lung Disease · NA · recruiting
- NCT05122026 — Safety and Tolerability of 1 Month Daily (1HP) and 3 Months Weekly (3HP) Isoniazid and Rifapentine With Pharmacokinetics · Phase 1, PHASE2 · active not recruiting
- NCT05122767 — Rifapentine and Isoniazid TB Preventive Therapy (3HP) for Children Taking Dolutegravir-based Antiretroviral Treatment (D · Phase 1, PHASE2 · active not recruiting
- NCT05515042 — Phase 2a Trial to Evaluate Safety and Immunogenicity of COVID-19 Vaccine Strategies in HIV-infected/Uninfected Adults. · Phase 2 · active not recruiting
- NCT05643781 — Tuberculosis as a Risk Factor for a Worse Outcome Post-Sars-CoV-2 Infection · completed
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 NCT05118490 (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 The Aurum Institute NPC
- Last refreshed: 12 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/NCT05118490.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing