RIPE vs RIPE Plus N-acetylcysteine in Patients With HIV/TB Co-infection
Status:
Unknown status
Trial end date:
2019-12-01
Target enrollment:
Participant gender:
Summary
Although tuberculosis is a treatable disease, it is currently the infectious disease with the
highest mortality in the world. It is estimated that one-third of the world's population is
infected. HIV is the main predisposing factor for TB development. The Brazilian Ministry of
Health and the World Health Organization recommends that patients should initially be treated
orally with RIPE - rifampicin (R), isoniazid (I), pyrazinamide (P) and ethambutol (E). The
N-acetylcysteine (NAC) first benefit was reported during the 1960s, when it proved to be an
effective mucolytic agent in individuals with cystic fibrosis. Later, a new role arose when
investigating its therapeutic potential in acetaminophen intoxication. Cleavage of the acetyl
group makes cysteine available for later incorporation into glutathione synthesis, decreased
in hepatic injury caused by acetaminophen. This mechanism causes NAC to have an indirect
antioxidant effect, which aroused an interest in studying the effect in diseases that occur
with oxidative stress. TB and HIV/Aids are also diseases with chronic inflammation. The
present study aims to evaluate the effects of NAC as a adjuvant therapy in the treatment of
TB. This is a phase II randomized clinical trial in which the safety and tolerability of NAC
as adjunctive therapy for TB treatment will be assessed. Fifty-six patients will be
randomized into two groups. The first group will receive the standard tuberculosis treatment
as recommended by the Brazilian Ministry of Health (RIPE); the second will receive in
addition to this treatment 1200mg of NAC per day for two months. In this way, microscopy and
culture conversion rate to mycobacteria at 8 weeks, levels of glutathione and biomarkers of
immune activation and inflammation in case of TB with or without NAC will be monitored.
Phase:
Phase 2
Details
Lead Sponsor:
Fundação de Medicina Tropical Dr. Heitor Vieira Dourado