deltatrials
Completed PHASE2 INTERVENTIONAL 3-arm NCT02583048

Evaluating the Safety, Tolerability, and Pharmacokinetics of Bedaquiline and Delamanid, Alone and in Combination, For Drug-Resistant Pulmonary Tuberculosis

A Trial of the Safety, Tolerability, and Pharmacokinetics of Bedaquiline and Delamanid, Alone and in Combination, Among Participants Taking Multidrug Treatment for Drug-Resistant Pulmonary Tuberculosis

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Conditions HIV Infections Tuberculosis
Interventions Bedaquiline Delamanid Dolutegravir Multidrug Background Treatment (MBT) for TB
Updated 17 times since 2017 Last updated: Jan 20, 2022 Started: Aug 15, 2016 Primary completion: Jan 7, 2019 Completion: Feb 4, 2021
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE2 trial investigates HIV Infections and Tuberculosis and is currently completed. National Institute of Allergy and Infectious Diseases (NIAID) leads this study, which shows 17 recorded versions since 2016 — indicating substantial longitudinal coverage. Longitudinal tracking of infectious disease trials helps identify durability of treatment effects.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshot~Feb 2017 – ~May 2017 · 3 months · monthly snapshot~May 2017 – ~Jun 2018 · 13 months · monthly snapshot~Jun 2018 – ~Jul 2018 · 30 days · monthly snapshot~Jul 2018 – ~Aug 2018 · 31 days · monthly snapshot~Aug 2018 – ~Sep 2018 · 31 days · monthly snapshot~Sep 2018 – ~Mar 2019 · 6 months · monthly snapshot~Mar 2019 – ~Feb 2020 · 11 months · monthly snapshot~Feb 2020 – ~Jan 2021 · 11 months · monthly snapshot~Jan 2021 – ~Feb 2021 · 31 days · monthly snapshot~Feb 2021 – ~Mar 2021 · 28 days · monthly snapshot~Mar 2021 – ~May 2021 · 2 months · monthly snapshot~May 2021 – ~Nov 2021 · 6 months · monthly snapshot~Nov 2021 – ~Feb 2022 · 3 months · monthly snapshot~Feb 2022 – ~Jul 2024 · 29 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – present · 22 months · monthly snapshot

Change History

17 versions recorded

  1. Sep 2024 — Present [monthly]

    Completed PHASE2

  2. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE2

  3. Feb 2022 — Jul 2024 [monthly]

    Completed PHASE2

  4. Nov 2021 — Feb 2022 [monthly]

    Completed PHASE2

  5. May 2021 — Nov 2021 [monthly]

    Completed PHASE2

    Status: Active Not Recruiting → Completed

▶ Show 12 earlier versions

  1. Mar 2021 — May 2021 [monthly]

    Active Not Recruiting PHASE2

  2. Feb 2021 — Mar 2021 [monthly]

    Active Not Recruiting PHASE2

  3. Jan 2021 — Feb 2021 [monthly]

    Active Not Recruiting PHASE2

  4. Feb 2020 — Jan 2021 [monthly]

    Active Not Recruiting PHASE2

  5. Mar 2019 — Feb 2020 [monthly]

    Active Not Recruiting PHASE2

  6. Sep 2018 — Mar 2019 [monthly]

    Active Not Recruiting PHASE2

  7. Aug 2018 — Sep 2018 [monthly]

    Active Not Recruiting PHASE2

    Status: Recruiting → Active Not Recruiting

  8. Jul 2018 — Aug 2018 [monthly]

    Recruiting PHASE2

  9. Jun 2018 — Jul 2018 [monthly]

    Recruiting PHASE2

  10. May 2017 — Jun 2018 [monthly]

    Recruiting PHASE2

  11. Feb 2017 — May 2017 [monthly]

    Recruiting PHASE2

  12. Jan 2017 — Feb 2017 [monthly]

    Recruiting PHASE2

    First recorded

Aug 2016

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • National Institute of Allergy and Infectious Diseases (NIAID)
Data source: National Institute of Allergy and Infectious Diseases (NIAID)

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations