Tuberculosis Clinical Trial
Official title:
A Phase 2 Randomized, Open-label Trial of Daily Rifapentine 450mg or 600mg in Place of Rifampicin 600mg for Intensive Phase Treatment of Smear-positive Pulmonary Tuberculosis
The goal of this Phase 2 study is to determine the microbiological activity and safety of
rifapentine when given as a component of multidrug intensive phase treatment of
smear-positive pulmonary tuberculosis (TB).
Funding Source- FDA Office of Orphan Products Development (OOPD)
Prospective phase II, open-label, single center study in which each experimental rifapentine
regimen is evaluated using a two-stage design. Adults (HIV-negative, or HIV-positive with CD4
> 200 cells/cu mm) suspected to have pulmonary tuberculosis who meet eligibility criteria
will be randomized to receive one of three intensive phase regimens. Intensive phase regimens
will consist of once daily isoniazid, pyrazinamide, and ethambutol, plus one of the
following: rifampin 600 mg once daily OR rifapentine 450 mg once daily OR rifapentine 600 mg
once daily. Randomization will be stratified by presence/absence of cavitation on baseline
chest radiograph. In Stage 1, 15 subjects will be randomized to each arm, following which
there will be an enrollment pause for efficacy and safety assessment. Any rifapentine regimen
for which fewer than 6 of 11 evaluable participants have week 8 culture conversion will be
discarded.
Stage 2 will randomize subjects into the remaining "accepted arms" with a maximum of 36
additional subjects per arm.
All subjects will continue TB treatment with a conventional continuation phase treatment.
Study Site
Study subjects will be recruited from the University of Cape Town inpatient wards and
outpatient clinics.
Estimated Study Duration
It is estimated that 18 months will be required for recruitment and enrollment of study
subjects. The estimated duration of participation for each study subject is 18 months,
including 2 months of experimental intensive phase TB treatment, 4 months of non-experimental
conventional continuation phase TB treatment, and an additional 12 months for follow-up for
TB relapse.
Study Management
Study subjects will have study visits on days 0, 7, 14, 21, 28, 35, 42, 49, and 56 for sputum
collection and adverse event assessment. Safety laboratory monitoring will be performed on
days 14, 28, 42, and 56 and will consist of complete blood count, serum alanine
aminotransferase, serum total bilirubin, and serum creatinine. Steady state pharmacokinetic
analysis will be performed on approximately day 28. Subjects will have additional study
visits at week 10 and at months 4, 6, 12, and 18.
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