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NCT02273765: REFLATE TB2

Raltegravir Versus Efavirenz in Naive HIV-1-infected Patients Receiving Rifampin for Active Tuberculosis

Completed Phase 3 Last updated 31 December 2018
What this trial tests

Phase 3 trial testing Tenofovir + lamivudine + raltegravir in HIV-1 Infection in 460 participants. Completed in 28 November 2018.

Timeline
11 September 2015
Primary endpoint
28 November 2018
28 November 2018

Quick facts

Lead sponsorANRS, Emerging Infectious Diseases
PhasePhase 3
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment460
Start date11 September 2015
Primary completion28 November 2018
Estimated completion28 November 2018
Sites5 locations across France, Vietnam, Mozambique, Côte d’Ivoire, Brazil

Drugs / interventions tested

Conditions studied

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):

  1. 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
  2. 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
  3. 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
  4. 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

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Other recruiting trials for HIV-1 Infection

Currently open trials in the same condition.

Other ANRS, Emerging Infectious Diseases trials

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Data sources for this page

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