Phase
Condition
Hiv
Lung Disease
Treatment
Ethionamide 250 mg
BVL-GSK098 9mg
Isoniazid 300 MG
Clinical Study ID
Ages 18-65 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Participants are required to meet all the following criteria in order to berandomized.
Provide written, informed consent prior to all trial-related procedures.
Male or female, aged between 18 and 65 years, inclusive.
Body weight (in light clothing and with no shoes) between 40 and 90 kg, inclusive.
Newly diagnosed and untreated pulmonary TB.
Rifampicin- and isoniazid-susceptible pulmonary TB as determined by moleculartesting (GeneXpert XDR or Genotype MTBDRplus for INH).
A chest X-ray taken during the screening period or up to 2 weeks before screeningwhich, in the opinion of the investigator, is consistent with TB.
GeneXpert positive with a quantitative readout of medium or high.
Ability to produce an adequate volume of sputum as estimated from an overnightsputum collection sample (estimated 10 ml or more).
Be of non-childbearing potential or using effective methods of birth control.
For WOCBP, injectable or other contraceptive methods (per Appendix 1) need to begiven prior to or during screening, and at least 2 days prior to first dose of IP.
Exclusion
Exclusion Criteria:
- Participants will be excluded from participation if they fulfil any of thefollowing criteria. Medical History
Evidence of clinically significant conditions or findings, other than TB, that mightcompromise safety or the interpretation of trial endpoints, per discretion of theinvestigator.
History of epilepsy, seizures or other neuropsychiatric disorders that mightcompromise safety or the interpretation of trial endpoints, per discretion of theinvestigator
History of hypothyroidism
QTcF of >450 ms at baseline
Clinically significant evidence of extrathoracic TB, as judged by the investigator.
History of allergy to any of the trial IP as confirmed by the clinical judgement ofthe investigator.
Alcohol or drug abuse, that in the opinion of the investigator, is sufficient tocompromise the safety or cooperation of the participant.
HIV positive AND:
CD4 < 250cells/mm3
OR, on ART in stage 1 only. Participants established on ART (2 NRTIs anddolutegravir) for more than 30 days at start of screening are eligible forparticipation in stage 2. NOTE: ART permitted in Stage 2 is limited to the following in line with localguidelines for 1st line ART:
NRTIs selected from: Emtricitabine, Lamivudine, Tenofovir
PLUS Dolutegravir As the drug-drug interaction potential of ART has not been fully investigated withthe IP, NNRTIs (efavirenz, nevirapine) and other protease inhibitors will not bepermitted in this study.
Female participant who is pregnant, breast-feeding, or planning to conceive a childwithin the anticipated period of trial participation. Male participant planning toconceive a child for at least 90 days, after the last dose of study intervention inthe trial. Treatment History
Participation in other clinical studies with investigational agents within 8 weeksprior to screening.
Treatment received for this episode of TB with any drug active against M.tb (including but not limited to isoniazid, ethambutol, amikacin, cycloserine,fluoroquinolones, rifabutin, rifampicin, streptomycin, kanamycin,para-aminosalicylic acid, rifapentine, pyrazinamide, thioacetazone, capreomycin,thioamides).
Treatment with immunosuppressive medications such as TNF-alpha inhibitors within 2weeks prior to screening, or systemic corticosteroids for more than 7 days within 2weeks prior to screening.
Study Design
Study Description
Connect with a study center
TASK Clinical Research Centre
Cape Town, Western Cape 7530
South AfricaSite Not Available
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