Comparing Daily vs Intermittent Regimen of ATT in HIV With Pulmonary Tuberculosis
Status:
Completed
Trial end date:
2018-06-30
Target enrollment:
Participant gender:
Summary
Acquired Rifampicin Resistance has emerged as an important issue in the treatment of HIV-TB
patients. It has not been a major problem in HIV-negative individuals treated for TB treated
with standard intermittent regimens. The study would generate data on the efficacy of daily
and thrice weekly regimen of ATT in pulmonary TB patients with HIV in the presence of highly
active antiretroviral therapy (HAART). Not many trials have compared sputum conversion and
adverse drug reaction between daily and intermittent regimens of ATT in HIV positive
patients. This study provides a unique opportunity for comparison of daily and intermittent
therapy for HIV patients with pulmonary TB looking into multiple dimensions of HIV-TB
treatment namely efficacy, drug resistance, toxicity , drug interaction and immune
reconstitution inflammatory syndrome. The primary outcome of the study is to compare the
efficacy of three anti-TB regimens in a) reducing bacteriological failures and b) decreasing
the emergence of Acquired Rifampicin Resistance (ARR). The secondary outcomes include
unfavourable responses (clinical failures, deaths, relapses) as whole, treatment emergent
adverse drug reactions, pharmacokinetic levels of ATT and incidence of immune reconstitution
syndrome.