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New TB cocktails aim to speed up recovery

NCT ID NCT06192160

Disease control Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 11, 2026 · Updated 11 times

Summary

This study tests new combinations of drugs for adults with lung tuberculosis (TB). The goal is to see if these new regimens work faster and are safer than the current standard treatment. About 315 participants will receive either an experimental drug combo or the usual care for 8 weeks, then standard treatment for 18 more weeks. The study tracks how quickly the TB bacteria are cleared from sputum and monitors for side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 315 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2025

Expected to finish

Aug 2027

An estimate. End dates often move.

Lead sponsor

A government research agency

The lead sponsor is the US National Institutes of Health.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Pulmonary TB (among individuals either without history of prior TB treatment or with history of TB treatment completed more than 2 years prior to study entry), identified within 7 days prior to study entry by at least one sputum specimen positive for Mtb by Xpert. Semiquantitative Mtb results of "medium" or "high" from Xpert MTB/RIF Ultra are required. 2. Pulmonary TB with documented INH susceptibility (by Line Probe Assay (LPA) or Xpert MTB/XDR or other validated molecular test) and with documented RIF susceptibility (by LPA or Xpert MTB/RIF or Xpert MTB/RIF Ultra or other validated molecular test) within 7 days prior to study entry. 3. Documentation of HIV-1 infection status, as below: Presence or absence of HIV-1 infection, as documented by: * Any licensed rapid HIV test or HIV-1 enzyme or chemiluminescence immunoassay (E/CIA) test kit, any time prior to study entry. AND for a positive result confirmation by one of the following: * A second antibody test from different manufacturers or based on different principles and epitopes (combination antigen-antibody-based rapid tests may be used), or * HIV-1 antigen, or * Plasma HIV-1 RNA viral load, or * A licensed Western blot 4. For individuals with HIV: CD4+ cell count ≥100 cells/mm3 based on testing performed within 30 days prior to study entry. 5. For individuals with HIV: Currently being treated with dolutegravir-based antiretroviral therapy (ART), or plan to initiate dolutegravir-based ART at or before study week 8. 6. Individuals age ≥18 years. 7. The following laboratory values obtained within 7 days prior to study entry at any network-approved non-U.S. laboratory that operates in accordance with Good Clinical Laboratory Practices (GCLP) and participates in appropriate external quality assurance programs: * Serum or plasma alanine aminotransferase (ALT) ≤3 times the upper limit of normal (ULN) * Serum or plasma total bilirubin ≤2 times ULN * Serum or plasma creatinine ≤2 times ULN * Serum or plasma potassium ≥3.5 mEq/L * Serum or plasma magnesium ≥1.0 mEq/L (≥0.500 mmol/L) * Absolute neutrophil count (ANC) ≥1500/mm\^3 * Hemoglobin ≥9.0 g/dL * Platelet count ≥100,000/mm\^3 * Negative for, hepatitis B surface antigen (HBsAg) * Negative for hepatitis C virus (HCV) antibody (or if HCV antibody positive, must have a negative HCV PCR) 8. For female study candidates who are of reproductive potential, negative pregnancy test (urine HCG or serum β-HCG) within 3 days (72 hours) prior to entry by any network-approved non-U.S. laboratory or clinic that operates in accordance with GCLP and participates in appropriate external quality assurance programs. Females who are of reproductive potential and who participate in sexual activity that could lead to pregnancy must agree to use at least two of the following forms of birth control while receiving TB study medications and for 12 months after stopping study medications: * Male or female condoms * Diaphragm or cervical cap (with spermicide, if available) * Intrauterine device (IUD) or intrauterine system (IUS) * Hormone-based birth control (e.g., oral contraceptives, Depo-Provera, NuvaRing, implants) Female study candidates who are of reproductive potential, but who abstain from sexual activity that could lead to pregnancy require no additional contraception. Female study candidates who are not of reproductive potential are eligible without requiring the use of contraceptives. Self-reported history is acceptable documentation of menopause (i.e., at least 1 year amenorrheic), hysterectomy, bilateral oophorectomy, or bilateral tubal ligation; these candidates are all considered not of reproductive potential. 9. For male study candidates who engage in sexual activity that may lead to pregnancy in their partner must agree to either remain abstinent or use male contraceptives. They are also strongly advised to inform their non-pregnant sexual partners of reproductive potential to use effective contraceptives while the individual is on study and for 90 days after experimental treatment discontinuation. For male study candidates who have undergone successful vasectomy with documented azoospermia or have documented azoospermia for any other reason, are eligible without requiring the use of contraceptives. 10. For male study candidates with pregnant partners, willingness to use condoms during vaginal intercourse while on study and for 90 days after experimental treatment discontinuation. 11. For male study candidates, willingness to refrain from sperm donation while on study and for 90 days after experimental treatment discontinuation. 12. Documentation of Karnofsky performance score ≥60 obtained within 14 days prior to study entry. 13. Chest x-ray obtained within 14 days prior to study entry. 14. A verifiable address or residence readily accessible for visiting, and willingness to inform the study team of any change of address during study treatment and follow-up period. 15. Ability and willingness of individual to provide informed consent. Exclusion Criteria: 1. More than cumulative 7 days of treatment directed against active TB for the current TB episode in the 60 days preceding study entry. 2. Current extrapulmonary TB, in the opinion of the investigator. 3. QTcF interval \>450 ms within 7 days prior to study entry. 4. History of or ongoing heart failure. 5. Personal or family history of congenital QT prolongation. 6. History of known, untreated, ongoing hypothyroidism. 7. History of or ongoing bradyarrhythmia. 8. History of torsades de pointes. 9. Current Grade 2 or higher peripheral neuropathy. 10. Other medical conditions (e.g., diabetes, liver or kidney disease, blood disorders, chronic diarrhea), in the opinion of the site investigator, in which the current clinical condition of the participant is likely to prejudice the response to, or assessment of, treatment. 11. Pregnant or breastfeeding or planning to become pregnant within the next 12 months. 12. Weight \<35 kg. 13. Unable to take oral medications. 14. Taking any of prohibited medications. 15. Known allergy/sensitivity or any hypersensitivity to components of investigational agents or their formulation. 16. Active drug or alcohol use or dependence; or mental illness (e.g., major depression) that, in the opinion of the site investigator, would interfere with adherence to study requirements. 17. Taking an investigational drug or vaccine within 30 or more days prior to study entry.

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Conditions

The condition(s) this trial relates to.

pulmonary tuberculosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Pulmonary tuberculosis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    29 sites in 14 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • 11101, University of the Witwatersrand Helen Joseph (WITS HJH) CRS

    RECRUITING

    Johannesburg, 2193, South Africa

  • 11201, Durban International CRS

    RECRUITING

    Durban, 4091, South Africa

  • 11301, Barranco CRS

    RECRUITING

    Lima, 1010, Peru

  • 11302, San Miguel CRS San Miguel

    RECRUITING

    Lima, Peru

  • 12001, Malawi CRS

    NOT_YET_RECRUITING

    Lilongwe, A-104, Malawi

  • 12101, Instituto de Pesquisa Clinica Evandro Chagas (IPEC) CRS

    RECRUITING

    Rio de Janeiro, 21040, Brazil

  • 12201, Instituto de Pesquisas em AIDS do Rio Grande do Sul - IPARGS CRS

    RECRUITING

    Porto Alegre, 91350, Brazil

  • 12301, Soweto ACTG CRS

    RECRUITING

    Johannesburg, 1864, South Africa

  • 12401, Joint Clinical Research Centre (JCRC)/Kampala CRS

    RECRUITING

    Kampala, 10005, Uganda

  • 12501, Kenya Medical Research Institute/Walter Reed Project Clinical Research Center (KEMRI/WRP) CRS

    RECRUITING

    Kericho, 20200, Kenya

  • 12601, Moi University Clinical Research Center (MUCRC) CRS

    RECRUITING

    Eldoret, 30100, Kenya

  • 12701, Gaborone CRS

    RECRUITING

    Gaborone, 0000, Botswana

  • 30022, Les Centres GHESKIO Clinical Research Site (GHESKIO-INLR) CRS

    RECRUITING

    Port-au-Prince, 6110, Haiti

  • 30293 MU-JHU Research Collaboration (MUJHU CARE LTD) CRS

    RECRUITING

    Kampala, 23491, Uganda

  • 30301, Blantyre CRS

    NOT_YET_RECRUITING

    Blantyre, 265, Malawi

  • 30313, Milton Park CRS

    NOT_YET_RECRUITING

    Harare, 30313, Zimbabwe

  • 31422, CAPRISA eThekwini CRS

    RECRUITING

    Durban, 40001, South Africa

  • 31441, Byramjee Jeejeebhoy Medical College (BJMC) CRS

    RECRUITING

    Pune, 411001, India

  • 31684, Rustenburg CRS

    RECRUITING

    Rustenburg, South Africa

  • 31730, GHESKIO Institute of Infectious Diseases and Reproductive Health (GHESKIO - IMIS) CRS

    RECRUITING

    Port-au-Prince, 6110, Haiti

  • 31784, Chiang Mai University HIV Treatment (CMU HIV Treatment) CRS

    RECRUITING

    Chiang Mai, 50200, Thailand

  • 31792, University of Cape Town Lung Institute (UCTLI) CRS

    RECRUITING

    Cape Town, 7700, South Africa

  • 31793, South African Tuberculosis Vaccine Initiative (SATVI) CRS

    RECRUITING

    Cape Town, 6850, South Africa

  • 31802, Thai Red Cross AIDS Research Centre (TRC-ARC) CRS

    RECRUITING

    Pathum Wan, 10330, Thailand

  • 31981, TB HIV Innovations and Clinical Research Foundation Corp.

    RECRUITING

    Cavite, 4114, Philippines

  • 31985, Socios En Salud Sucursal Perú CRS

    RECRUITING

    Lima, Lima Province, 15046, Peru

  • 32078, Nutrición-Mexico CRS

    NOT_YET_RECRUITING

    Mexico City, 14080, Mexico

  • 32483 National Lung Hospital CRS

    RECRUITING

    Hanoi, 100000, Vietnam

  • 5116 Chiangrai Prachanukroh Hospital NICHD CRS

    RECRUITING

    Chiang Rai, Changwat Chiang Rai, 57000, Thailand

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