Status:
UNKNOWN
RIPE vs RIPE Plus N-acetylcysteine in Patients With HIV/TB Co-infection
Lead Sponsor:
Fundação de Medicina Tropical Dr. Heitor Vieira Dourado
Conditions:
Tuberculosis, Pulmonary
HIV/AIDS
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 ...
Detailed Description
TB and AIDS are also diseases that occur with a chronic inflammatory stimulus, with constant formation of excessive free radicals, leading to cellular and systemic oxidative stress. The effects of NAC...
Eligibility Criteria
Inclusion
- Age greater than or equal to 18 years;
- Acceptance of the HIV test;
- Forecast of hospital stay of more than twenty-four hours;
- Clinical and laboratory indication of RIPE;
- Conditions for puncture of venous access;
Exclusion
- Brazilian indigenous people;
- People the refuse to perform HIV test;
- Pregnant women, nursing mothers or pregnant women,
- Extra pulmonary TB, without pulmonary involvement;
- Not be able to perform the collection of sputum or tracheal aspirate for microbiological confirmation;
- No MGIT® positive for Mtb;
- Resistance to Mtb, detected by professional sensitivity;
- Individuals under treatment for bronchospasm secondary to bronchial asthma, according to the decision of the assistant team or researcher of the study;
- Clinical suspicion of gastric or duodenal ulcer, as decided by the assistant team or study investigator; or evidence by upper digestive endoscopy;
- Alanine aminotransferase (ALT) greater than three times normal;
- Need to suspend the RIPE treatment, according to the decision of the assistant team or researcher of the study;
- Lack of adherence to the proposed treatment for more than seven consecutive days.
Key Trial Info
Start Date :
December 7 2016
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2019
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT03281226
Start Date
December 7 2016
End Date
December 1 2019
Last Update
February 15 2019
Active Locations (1)
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1
Fundação de Medicina Tropical Dr. Heitor Vieira Dourado
Manaus, Amazonas, Brazil, 69040000