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New treatment option for Tuberculosis, Latent
Official title Bedaquiline Roll-out Evidence in Contacts and People Living With HIV to Prevent TB
ClinicalTrials.gov ID: NCT06568484
What this study is testing
What is Bedaquiline?
Bedaquiline is an investigational medicine, given as an once-daily, being studied as a potential treatment for tuberculosis, latent.
Also referred to as Sirturo.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- A seamless, staged Phase II/III, open-label, multicenter, non-inferiority trial, to compare the efficacy and safety of 4 weeks of bedaquiline (BDQ) versus a a standard regimen for preventing regimen for preventing confirmed or probable tuberculosis disease (TBD) during 72 weeks of follow-up among people living with HIV (PLHIV) and high-risk Close Contacts (CC) of adults with Drug Susceptible (DS) or Rifampin Resistant (RR) TB.
- Phase 3: a large, late-stage study
- Time commitment: about 72 weeks
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Adults
You may be able to join if
- For Index Patient
- Any age
- A diagnosis of bacteriologically proven pulmonary TB
- Initiated on treatment for pulmonary TB within the past 90 days
- Have at least one close contact that is likely to be eligible for the study For PLHIV Indication Individuals must meet all of the following to...
You likely can't join if
- Exclusion Criteria for Index Patient A. Unwilling or unable to provide informed consent B. No close contacts likely to be eligible for the study C...
- Severe renal impairment (DAIDS Grade 4) or end-stage renal disease requiring hemodialysis or peritoneal dialysis
- Severe hepatic impairment (Child-Pugh C)
- Evidence of acute hepatitis, such as abdominal pain, jaundice, dark urine, and/or light stools within 90 days prior to enrollment
- Severe cardiac arrythmia requiring medication
- Peripheral neuropathy ≥ Grade 2 (DAIDS)
See the full eligibility criteria
Who can join
- For Index Patient
- Any age
- A diagnosis of bacteriologically proven pulmonary TB
- Initiated on treatment for pulmonary TB within the past 90 days
- Have at least one close contact that is likely to be eligible for the study For PLHIV Indication Individuals must meet all of the following to participate in this study:
- On a dolutegravir-based or other approved integrase inhibitor antiretroviral therapy (ART) regimen that does not interact with bedaquiline or rifapentine.
- If on a protease inhibitor-based ART regimen, a participant can be enrolled following a 5-day washout with switch to a dolutegravir-based regimen prior to enrollment. A 14-day washout is required for efavirenz-based ART...
- If a participant is not currently on ART or is ART-naïve, the participant must have started a dolutegravir-based ART regimen prior to Enrollment.
- PLHIV who meet criteria for a TBD close contact should be enrolled under the close contact indication For Close Contact Indication (DS- or RR-TB Index Patient)
- Definition of Close Contact (either/or): o Lives or lived in the same dwelling unit or plot of land and shares or has shared the same housekeeping arrangements as the Index Patient for one or more nights ≤ 90 days prior...
- Close contacts must be in one of the following high-risk groups:
- All children 0 to \<5 years old at the time of Enrollment, regardless of LTBI or HIV status
- Adults, adolescents, and children ≥5 years of age who are TBI test positive (either skin test positive\ or IGRA-positive) and whose HIV status is negative, indeterminate, or unknown.
- Adults, adolescents, and children ≥5 years of age who have a documented HIV infection regardless of TBI test status. Universal Enrollment for PLHIV and Close Contacts of DS- or RR-TB Index Patient A. Ability and...
- Certified copy of HIV clinic card or
- Certified copy of HIV testing that includes date, assay used and result For participants \<18 months of age who have never tested, or previous HIV test result was indeterminate, unknown, or negative more than three...
- HIV-1 testing should be performed per Section 5.4.5 (HIV-1 Testing) during the study screen period. For participants \<18 months known to be CLHIV:
- Certified copies of HIV DNA and/or RNA testing that includes date, assay used, and result For participants \<18 months who have never tested, or previous HIV test result was indeterminate, unknown, or negative more than...
- HIV-1 testing should be performed per Section 5.4.5 (HIV-1 Testing) during the study screen period C. Documentation of ART
- All PLHIV (for PLHIV indication and CC that are PLHIV) must be on a dolutegravir-based or other approved integrase inhibitor ART regimen that does not interact with bedaquiline or rifapentine.
- If on a protease inhibitor-based ART regimen, a participant can be enrolled following a 5-day washout with switch to a dolutegravir-based regimen prior to enrollment. A 14-day washout is required for efavirenz-based ART...
- If a participant is not currently on ART or is ART-naïve, they must have started a dolutegravir-based ART regimen prior to Enrollment. D. Chest radiograph without evidence of active TBD, performed within 30 days prior...
- Alanine aminotransferase (ALT) ≤ 3 times the upper limit of normal
- Total bilirubin ≤ 2.5 times the upper limit of normal
- Alkaline phosphatase ≤ 3 times the upper limit of normal
- Creatinine clearance ≥ 29 ml/min
- Serum potassium at or above the lower limit of normal
- Serum magnesium at or above the lower limit of normal
- Serum calcium at or above the lower limit of normal
- Platelet count of ≥ 50,000 /mm3
- Absolute neutrophil count (ANC) ≥ 1,000/mm3 F. Pregnancy test (for study candidates of childbearing potential\ )
- Negative serum or urine pregnancy test within 7 days prior to enrollment. \ NOTE: Participants of childbearing potential are defined as females who have reached menarche or who have not been post-menopausal for at least...
What rules you out
- Exclusion Criteria for Index Patient A. Unwilling or unable to provide informed consent B. No close contacts likely to be eligible for the study C. Study staff unable to obtain status of TB drug susceptibility or...
- Severe renal impairment (DAIDS Grade 4) or end-stage renal disease requiring hemodialysis or peritoneal dialysis
- Severe hepatic impairment (Child-Pugh C)
- Evidence of acute hepatitis, such as abdominal pain, jaundice, dark urine, and/or light stools within 90 days prior to enrollment
- Severe cardiac arrythmia requiring medication
- Peripheral neuropathy ≥ Grade 2 (DAIDS)
- Diagnosis of porphyria at any time prior to study enrollment
- Corrected QTcF (Fridericia's formula) of \>460 msec
- Unable to take oral medication
- Active drug or alcohol use or dependence that, in the site investigator's opinion, would interfere with adherence to study treatment.
- Serious illness requiring systemic treatment including parenteral therapy (e.g., antibiotics) and/or hospitalization within 30 days prior to Enrollment
- Prior exposure to bedaquiline or clofazimine
- Receipt of more than 7 cumulative days of isoniazid, a rifamycin, or a fluoroquinolone in the 90 days prior to enrollment
- Known bedaquiline resistance in Index Patient
- Known allergy/sensitivity or any hypersensitivity to components of study drugs or their formulation
- Currently taking another medication that is prohibited with study medicines which cannot be stopped (with or without replacement) or requires a washout period longer than 14 days (See Appendix 7)
- Known pregnancy or breastfeeding Specific Exclusion Criteria for Close Contacts of RR-TB Index Patient
- Known fluoroquinolone resistance in Index Patient
- Severe tendinopathy related to fluoroquinolones
The study team makes the final eligibility decision.
Where it's taking place
- Lima, Peru
- Moshi, Tanzania
- Kampala, Uganda
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 72 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, not specified. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Lima, Peru; Moshi, Tanzania; Kampala, Uganda. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.