Could a 3-Month TB cocktail replace the standard 6-Month regimen?

NCT ID NCT04311502

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
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 Results may not be published yet.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 This study
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This status has not been confirmed recently, so it may be out of date.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 Jul 08, 2026 · Last updated Jul 09, 2026 · Updated 1 time

Summary

This clinical trial investigates whether a 3-month combination of clofazimine and rifapentine can effectively treat drug-susceptible tuberculosis (TB) compared to the standard 6-month regimen. The study includes adults with pulmonary TB, some of whom also have HIV. Researchers are measuring how quickly the bacteria clear from sputum and tracking any serious side effects over 65 weeks.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Clofazimine and Rifapentine
What this could lead to
If successful, this could shorten tuberculosis treatment from 6 months to 3 months, making it easier for patients to complete therapy and potentially reducing transmission.
What could go wrong
This is a Phase 2 trial with only 104 participants, so results may not apply to everyone. The shorter regimen may be less effective or cause more side effects than standard care.

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

104 people

The number who actually took part.

Started

Nov 2021

Finished

Jun 2025

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: * Pulmonary TB (among participants with or without history of prior TB treatment) identified within 5 days prior to entry by: * At least one sputum specimen positive for M. tuberculosis by molecular TB assay (Xpert) or line probe assay \[LPA\]) OR * At least one sputum specimen positive (1+ or greater) for acid-fast bacilli (AFB) on smear microscopy * Note: TB diagnosis for purposes of meeting inclusion criterion can be from a study testing laboratory or from an outside laboratory, as long as it is from a sputum sample collected within 5 days prior to entry. * Pulmonary TB diagnosed without known INH resistance (e.g., by LPA or Xpert) and without known RIF resistance (e.g., by either LPA or Xpert). * Absence of HIV-1 infection, as documented by any licensed rapid HIV test or HIV-1 enzyme or chemiluminescence immunoassay (E/CIA) test kit, within 30 days prior to entry OR HIV-1 infection, documented by any licensed rapid HIV test or HIV-1 E/CIA test kit at any time prior to entry and confirmed by a licensed Western blot or a second antibody test by a method other than the initial rapid HIV and/or E/CIA, or by HIV-1 antigen or plasma HIV-1 RNA viral load. Two or more HIV-1 RNA viral loads of \>1,000 copies/mL are also acceptable as documentation of HIV-1 infection. * For participants living with HIV, CD4+ cell count ≥100 cells/mm\^3, obtained within 30 days prior to study entry at any network-approved non-US laboratory that is Immunology Quality Assessment (IQA) certified. * For participants living with HIV must be currently receiving or planning to initiate antiretroviral therapy (ART) at or before study week 8. * A verifiable address or residence readily accessible to facilitate directly observed therapy (DOT), and willingness to inform the study team of any change of address during the treatment and follow-up period. * The following laboratory values obtained at or within 5 days prior to entry by any US laboratory that has a Clinical Laboratory Improvement Amendments (CLIA) certification or its equivalent, or at any network-approved non-US laboratory that operates in accordance with Good Clinical Laboratory Practice (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 ≤2.5 times ULN * Serum or plasma creatinine ≤2 times ULN * Serum or plasma potassium ≥3.5 mEq/L and ≤5.5 mEq/L * Absolute neutrophil count (ANC) ≥650/mm\^3 * Hemoglobin ≥7.0 g/dL * Platelet count ≥50,000/mm\^3 * For females of reproductive potential, negative serum or urine pregnancy test within 5 days prior to entry by any US clinic or laboratory that has a Clinical Laboratory Improvement Amendments (CLIA) certification or its equivalent, or is using a point of care (POC)/CLIA-waived test, or at any network-approved non-US laboratory or clinic that operates in accordance with Good Clinical Laboratory Practice (GCLP) and participates in appropriate external quality assurance programs. * Female participants of reproductive potential must agree not to participate in the conception process (i.e., active attempt to become pregnant, in vitro fertilization), and if participating in sexual activity that could lead to pregnancy, must agree to use at least one reliable nonhormonal method of contraception, as listed below, while on study treatment and for 30 days after stopping study medications. * Acceptable forms of contraception include: * Condoms * Intrauterine device or intrauterine system * Cervical cap with spermicide * Diaphragm with spermicide * Note: Hormonal birth control alone is not acceptable, as it may not be sufficiently reliable in combination with RPT or RIF. * Female participants who are not of reproductive potential must have documentation of menopause (i.e., at least 1 year amenorrheic), hysterectomy, or bilateral oophorectomy or bilateral tubal ligation. * Documentation of Karnofsky performance score ≥50 within 30 days prior to entry. * Documentation of either the presence or absence of advanced disease as determined by chest X-ray within 5 days prior to entry. * Ability and willingness of participant to provide informed consent. Exclusion Criteria: * More than 5 days of treatment directed against active TB for the current TB episode preceding study entry. * Pregnant or breast-feeding. * Unable to take oral medications. * Current receipt of clofazimine or bedaquiline or known receipt of clofazamine or bedaquiline at any time in the past. * Corrected QT based on the Fridericia correction method (QTcF) interval \>450 ms for men or \>470 ms for women within 30 days prior to entry. * Weight \<30 kg. * Current or planned use within 6 months following enrollment of one or more of the following medications: HIV protease inhibitors, HIV entry and fusion inhibitors, HIV non-nucleoside reverse transcriptase inhibitors (other than EFV), elvitegravir/cobicistat, bictegravir, quinidine, procainamide, amiodarone, sotalol, disopyramide, ziprasidone, or terfenadine. * Current extrapulmonary TB, in the opinion of the site investigator. * Current or history of known personal or family long QT syndrome. * Known allergy/sensitivity or any hypersensitivity to components of study TB drugs or their formulation. * Active drug, 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. * Known history of acute intermittent porphyria. * Other medical conditions (e.g., severe uncontrolled diabetes, liver or kidney disease, blood disorders, peripheral neuritis, chronic diarrhea) in which the current clinical condition of the participant is likely to prejudice the response to, or assessment of, treatment.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Blantyre CRS

    Blantyre, 1131, Malawi

  • Byramjee Jeejeebhoy Medical College (BJMC) CRS

    Pune, 411001, India

  • CAPRISA eThekwini CRS

    Durban, KwaZulu-Natal, 4013, South Africa

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

    Port-au-Prince, HT-6110, Haiti

  • Malawi CRS

    Lilongwe, Central Region, Malawi

  • Milton Park CRS

    Harare, Zimbabwe

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