Evaluating a new treatment regimen for patients with multidrug-resistant TB (MDR-TB)
- Conditions
- HIV/AIDSTuberculosis
- Registration Number
- PACTR201409000848428
- Lead Sponsor
- university of Cape Town Lung Institute
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Male
- Target Recruitment
- 256
¿Provide written, informed consent prior to all trial-related procedures including HIV testing.
¿Male or female, aged 18 years and older.
¿Body weight (in light clothing and with no shoes) between 40 and 90 kg, inclusive.
¿Newly diagnosed culture and/or GeneXpert positive pulmonary TB.
¿GeneXpert rifampicin resistance confirmed on an alternative method of susceptibility testing (line probe assay (LPA) or phenotypic DST using a culture isolate or sputum sample.
¿Ability to produce an adequate volume of sputum as estimated from a spot assessment (estimated 10 ml or more overnight production).
¿Women of non-childbearing potential or using effective methods of birth control.
¿Previous history of treatment for MDR-TB.
¿Having received any drug active against MDR-TB within 3 months or less prior to enrolment.
¿Having been on treatment for drug sensitive TB treatment within 3 months or less prior to enrolment.
¿Currently on MDR-TB treatment for more than 2 weeks.
¿Fluoroquinolone-resistant and/or aminoglycoside-resistant TB detected (pre-XDR and XDR-TB).
¿Rifampicin mono-resistance.
¿Incompatibility between microbiological and clinic-radiological findings (i.e. where the clinico-radiological findings do not confirm the positive microbiological testing)
¿Primarily extra-thoracic TB as judged by the investigator.
¿History of allergy to any of the trial IMP/s or related substances.
¿Known or suspected, current alcohol or drug abuse, that is, in the opinion of the Investigator, sufficient to compromise the safety or cooperation of the participant.
¿Significant cardiac arrhythmia requiring medication.
¿Having participated in other clinical studies with investigational agents within 8 weeks prior to trial start.
¿Participants with specific ECG abnormalities at screening (see full protocol for details)
¿Participant who is pregnant, breast-feeding, or planning to conceive a child within 6 months of cessation of treatment.
¿Diabetes Mellitus requiring insulin.
¿History and/or presence (or evidence) of neuropathy or epilepsy.
¿History and/or presence (or evidence) of any haematogical disorder.
¿Specific concurrent treatments:
-Any diseases or conditions in which the use of the standard TB drugs or any of their components is contra-indicated, including but not limited to allergy to any TB drug, their component or to the IMP.
-Concomitant use of any drug (other than the study drugs) known to prolong QTc interval (see full protocol for details).
-Use of any drugs or substances within 30 days prior to dosing known to be strong inhibitors or inducers of cytochrome P450 enzymes (see full protocol for details). Exceptions may be made for participants that have received 3 days or less of one of these drugs or substances, if there has been a wash-out period before administration of IMP equivalent to at least 5 half-lives of that drug or substance.
-Use of any therapeutic agents known to alter any major organ function (see full protocol for details).
¿Laboratory abnormalities:
Participants with specific toxicities at screening as defined by the enhanced Division of Microbiology and Infectious Disease (DMID) adult toxicity table (November 2007) (see full protocol for details).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The proportion of patients with favourable outcome i.e. achieving treatment success (cure/completion) in either arm.
- Secondary Outcome Measures
Name Time Method Favourable outcome rate (time-specific and at the end of treatment);Rate of treatment failure (time-specific and at the end of treatment);time-specific culture conversion rates ;Adherence (monitored using a combination of self-report and/ or diary cards and/or DOTs);Adverse events ;Adverse drug reactions;Default rate ;Rate of loss to follow-up ;Interaction between bedaquiline and ART.;Relapse rate ;Rate of re-infection