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NCT02273765: REFLATE TB2
Raltegravir Versus Efavirenz in Naive HIV-1-infected Patients Receiving Rifampin for Active Tuberculosis
Phase 3 trial testing Tenofovir + lamivudine + raltegravir in HIV-1 Infection in 460 participants. Completed in 28 November 2018.
28 November 2018
Quick facts
| Lead sponsor | ANRS, Emerging Infectious Diseases |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 460 |
| Start date | 11 September 2015 |
| Primary completion | 28 November 2018 |
| Estimated completion | 28 November 2018 |
| Sites | 5 locations across France, Vietnam, Mozambique, Côte d’Ivoire, Brazil |
Drugs / interventions tested
- Tenofovir + lamivudine + raltegravir — full drug profile →
- Tenofovir + lamivudine + efavirenz
Conditions studied
- HIV-1 Infection — all drugs for HIV-1 Infection →
- Tuberculosis — all drugs for Tuberculosis →
Sponsor
ANRS, Emerging Infectious Diseases — full company profile →
Who can join
18 and older, any sex, with HIV-1 Infection or Tuberculosis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Phase III trial evaluating raltegravir as an alternative to efavirenz for antiretroviral treatment of HIV-infected patients with tuberculosis.
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
-
Standard dose raltegravir or efavirenz-based antiretroviral treatment for patients co-infected with HIV and tuberculosis (ANRS 12 300 Reflate TB 2): an open-label, non-inferiority, randomised, phase 3 trial.
De Castro N, Marcy O, Chazallon C, Messou E, et al · · 2021 · cited 21× · PMID 33667406 · DOI 10.1016/s1473-3099(20)30869-0 -
Determinants of Antiretroviral Treatment Success and Adherence in People With Human Immunodeficiency Virus Treated for Tuberculosis.
De Castro N, Chazallon C, N'takpe JB, Timana I, et al · · 2022 · cited 3× · PMID 36540390 · DOI 10.1093/ofid/ofac628 -
Incidence and Predictors of Tuberculosis-associated IRIS in People With HIV Treated for Tuberculosis: Findings From Reflate TB2 Randomized Trial.
Coelho LE, Chazallon C, Laureillard D, Escada R, et al · · 2024 · cited 2× · PMID 38486816 · DOI 10.1093/ofid/ofae035 -
Tuberculosis disease characteristics associated with mortality, severe morbidity and unsuccessful treatment in people living with HIV treated for tuberculosis - a secondary analysis of the ANRS 12300 Reflate TB2 trial.
Akpata R, Ntakpe JB, Messou E, De Castro N, et al · · 2025 · PMID 40361016 · DOI 10.1186/s12879-025-10986-4
Verify or expand the search:
- PubMed search for NCT02273765
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other ANRS, Emerging Infectious Diseases trials
Trials by the same sponsor.
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- NCT07113106 — Dose Escalation Trial of CD40.Pan.CoV Vaccine, Adjuvanted or Not, as a Booster in Adult Healthy Volunteers · Phase 1, PHASE2 · recruiting
- NCT05222945 — A Study to Determine the Cartography of Virologic Reservoir Related to Antiretroviral Concentrations in HIV-1 Chronic Pa · NA · not yet recruiting
- NCT06522256 — Identification of Molecular Signatures of High-risk Oncogenic HPV and Study of Their Associations With the Presence of H · 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)
- Trial protocol + status: ClinicalTrials.gov NCT02273765 (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 ANRS, Emerging Infectious Diseases
- Last refreshed: 31 December 2018
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/NCT02273765.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing