Last updated: February 16, 2024
Sponsor: Centre for the AIDS Programme of Research in South Africa
Overall Status: Active - Recruiting
Phase
N/A
Condition
Hiv
Lung Disease
Treatment
Xpert® MTB/XDR
Clinical Study ID
NCT05175794
CAPRISA 094
TRIAD
Ages 18-70 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Ambulant adults ≥ 18 years of age
- Newly diagnosed PTB patients receiving less than 5 days of treatment since newdiagnosis:
- Cohort 1: < 5 days of DR-TB treatment
- Cohort 2: < 5 days of INH mono-resistant TB treatment preceding study entry forthe current TB episode, or
- Sputum positive (smear and or culture) TB patients classified as failing first linetreatment
- Any currently available Nucleic Acid Amplification Tests for drug-resistance detectionchanges/assay positive for M.tb infection with: Cohort 1: at least Rifampicin resistance Cohort 2: Rifampicin susceptible co-occurringwith INH, fluoroquinolone, ethionamide or aminoglycoside resistance (detected by XpertXDR) occurring alone or in combination
- Capacity to provide informed consent
- HIV infected and uninfected participants are allowed in the study. Participantsalready on ART will be allowed in the study provided the ART regimen in use has nocontraindications to the proposed TB drug regimen
- Willing to have samples collected, stored indefinitely, and used for research purposes
- Able to provide reasonable proof of identity (to satisfaction of study team member) ator prior to enrolment
Exclusion
Exclusion criteria:
- Has a known severe allergy to any of the BPaL component drugs
- Has DST showing infection with a strain resistant to any of the component drugs
- Has TB meningitis, other central nervous system TB, or TB osteomyelitis; or
- Is pregnant or breastfeeding
- Is unable to take oral medications
- Persons with any other medical condition, precluding study participation based oninvestigator judgement
- Any co-existing condition that in the opinion of the attending clinician renders theparticipant unsuitable for participation in the study
- Co-enrolment in other interventional research studies
Study Design
Total Participants: 1280
Treatment Group(s): 1
Primary Treatment: Xpert® MTB/XDR
Phase:
Study Start date:
May 26, 2022
Estimated Completion Date:
June 01, 2025
Study Description
Connect with a study center
Ethiopian Public Health Institute (EPHI)
Gulele, Addis Ababa
EthiopiaActive - Recruiting
Institute of Human Virology Nigeria
Yaba, Lagos State
NigeriaActive - Recruiting
CAPRISA Springfield Research Clinic
Durban, KwaZulu-Natal 4091
South AfricaActive - Recruiting
Clinical HIV Research Unit (CHRU), WITS Health Consortium
Bethelsdorp, Port Elizabeth 6200
South AfricaActive - Recruiting
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