Actively Recruiting
Trial of Novel Regimens for the Treatment of Pulmonary Tuberculosis
Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2026-04-14
315
Participants Needed
29
Research Sites
126 weeks
Total Duration
On this page
Sponsors
N
National Institute of Allergy and Infectious Diseases (NIAID)
Lead Sponsor
T
TB Alliance
Collaborating Sponsor
AI-Summary
What this Trial Is About
A5409/RAD-TB is an adaptive Phase 2 randomized, controlled, open-label, dose-ranging, platform protocol to evaluate the safety and efficacy of multidrug regimens for the treatment of adults with drug-susceptible pulmonary tuberculosis (TB). A5409 hypothesizes that novel regimens for the treatment of pulmonary tuberculosis will result in superior early efficacy, as determined by longitudinal mycobacteria growth indicator tube (MGIT) liquid culture time to positivity (TTP) measurements over the first 6 weeks of treatment, and will have acceptable safety and tolerability over 8 weeks of treatment relative to standard of care \[(SOC) isoniazid/rifampicin/pyrazinamide/ethambutol (HRZE)\]. The study will run for 52 weeks, inclusive of 26 weeks of TB treatment comprised of 8 weeks of study treatment (experimental or SOC, based on treatment arm assignment) followed by 18 weeks of SOC continuation phase treatment with 45 participants in each experimental treatment arm and at least 90 participants in the SOC arm.
CONDITIONS
Official Title
Trial of Novel Regimens for the Treatment of Pulmonary Tuberculosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Diagnosed with pulmonary TB confirmed by positive sputum test within 7 days prior to entry with medium or high bacterial load
- Documented susceptibility to isoniazid and rifampicin by validated molecular tests within 7 days prior to entry
- Known HIV-1 infection status confirmed by licensed tests
- For HIV-positive individuals, CD4+ count of at least 100 cells/mm3 within 30 days prior to entry
- HIV-positive individuals treated with or planning to start dolutegravir-based therapy by week 8
- Laboratory values within specified safety ranges within 7 days prior to entry including liver, kidney function, blood counts, and negative hepatitis B and C tests
- Negative pregnancy test within 3 days prior to entry for females of reproductive potential
- Agreement to use effective contraception methods during and after treatment for females of reproductive potential
- Male participants engaging in sexual activity agree to use contraception or abstain during and after treatment
- Karnofsky performance score of 60 or higher within 14 days prior to entry
- Chest x-ray performed within 14 days prior to entry
- Stable residence and willingness to inform study team of address changes
- Ability and willingness to provide informed consent
You will not qualify if you...
- More than 7 cumulative days of TB treatment for current episode within 60 days prior to entry
- Presence of extrapulmonary TB
- QTcF interval greater than 450 ms within 7 days prior to entry
- History or ongoing heart failure or certain heart rhythm disorders
- Untreated or ongoing hypothyroidism
- Peripheral neuropathy of grade 2 or higher
- Other medical conditions that may affect treatment response or assessment
- Pregnant, breastfeeding, or planning pregnancy within 12 months
- Weight under 35 kg
- Inability to take oral medications
- Use of prohibited medications
- Known allergies or hypersensitivity to study drugs
- Active drug or alcohol dependence or certain mental illnesses interfering with adherence
- Participation in another investigational drug or vaccine study within 30 days prior to entry
AI-Screening
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Trial Site Locations
Total: 29 locations
1
12701, Gaborone CRS
Gaborone, Botswana, 0000
Actively Recruiting
2
12201, Instituto de Pesquisas em AIDS do Rio Grande do Sul - IPARGS CRS
Porto Alegre, Brazil, 91350
Actively Recruiting
3
12101, Instituto de Pesquisa Clinica Evandro Chagas (IPEC) CRS
Rio de Janeiro, Brazil, 21040
Actively Recruiting
4
30022, Les Centres GHESKIO Clinical Research Site (GHESKIO-INLR) CRS
Port-au-Prince, Haiti, 6110
Not Yet Recruiting
5
31730, GHESKIO Institute of Infectious Diseases and Reproductive Health (GHESKIO - IMIS) CRS
Port-au-Prince, Haiti, 6110
Not Yet Recruiting
6
31441, Byramjee Jeejeebhoy Medical College (BJMC) CRS
Pune, India, 411001
Not Yet Recruiting
7
12601, Moi University Clinical Research Center (MUCRC) CRS
Eldoret, Kenya, 30100
Not Yet Recruiting
8
12501, Kenya Medical Research Institute/Walter Reed Project Clinical Research Center (KEMRI/WRP) CRS
Kericho, Kenya, 20200
Actively Recruiting
9
30301, Blantyre CRS
Blantyre, Malawi, 265
Not Yet Recruiting
10
12001, Malawi CRS
Lilongwe, Malawi, A-104
Not Yet Recruiting
11
32078, Nutrición-Mexico CRS
Mexico City, Mexico, 14080
Not Yet Recruiting
12
11301, Barranco CRS
Lima, Peru, 1010
Not Yet Recruiting
13
31985, Socios En Salud Sucursal Perú CRS
Lima, Peru, 15046
Not Yet Recruiting
14
11302, San Miguel CRS San Miguel
Lima, Peru
Not Yet Recruiting
15
31981, TB HIV Innovations and Clinical Research Foundation Corp.
Cavite, Philippines, 4114
Not Yet Recruiting
16
31793, South African Tuberculosis Vaccine Initiative (SATVI) CRS
Cape Town, South Africa, 6850
Actively Recruiting
17
31792, University of Cape Town Lung Institute (UCTLI) CRS
Cape Town, South Africa, 7700
Actively Recruiting
18
31422, CAPRISA eThekwini CRS
Durban, South Africa, 40001
Actively Recruiting
19
11201, Durban International CRS
Durban, South Africa, 4091
Actively Recruiting
20
12301, Soweto ACTG CRS
Johannesburg, South Africa, 1864
Actively Recruiting
21
11101, University of the Witwatersrand Helen Joseph (WITS HJH) CRS
Johannesburg, South Africa, 2193
Not Yet Recruiting
22
31684, Rustenburg CRS
Rustenburg, South Africa
Actively Recruiting
23
31784, Chiang Mai University HIV Treatment (CMU HIV Treatment) CRS
Chiang Mai, Thailand, 50200
Actively Recruiting
24
5116 Chiangrai Prachanukroh Hospital NICHD CRS
Chiang Rai, Thailand, 57000
Actively Recruiting
25
31802, Thai Red Cross AIDS Research Centre (TRC-ARC) CRS
Pathum Wan, Thailand, 10330
Actively Recruiting
26
12401, Joint Clinical Research Centre (JCRC)/Kampala CRS
Kampala, Uganda, 10005
Actively Recruiting
27
30293 MU-JHU Research Collaboration (MUJHU CARE LTD) CRS
Kampala, Uganda, 23491
Not Yet Recruiting
28
32483 National Lung Hospital CRS
Hanoi, Vietnam, 100000
Actively Recruiting
29
30313, Milton Park CRS
Harare, Zimbabwe, 30313
Not Yet Recruiting
Research Team
R
Radojka Savic, PharmD, PhD
CONTACT
K
Kelly Dooley, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
6
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