STUDY OF EFFECTIVENESS AND TOLERABILITY OF ISONIAZIDE / RIFAPENTIN ONCE A WEEK FOR THREE MONTHS VERSUS ISONIAZIDE DAILY FOR NINE MONTHS FOR THE TREATMENT OF A LATENT INFECTION WITH TUBERCULOSIS

Not Applicable

• Conditions: -B24 Unspecified human immunodeficiency virus [HIV] disease; Unspecified human immunodeficiency virus [HIV] disease; B24

• Registration Number: PER-016-09
• Lead Sponsor: Institutos Nacionales de Salud (NIH, siglas en ingles) de los Estados Unidos de America,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-08-17
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

• Children 2 -11 years of age and people infected with HIV> 2 years of age
• People reactive to the Tuberculin dermoreaction test (PPD) with a high risk of developing TB without evidence of active TB. A high-risk reactive person is defined as:
1. Household members and other close contacts of people with confirmed TB culture who are TST-positive as part of a contact investigation within two years of the enrollment date. A close contact is defined as one with> 4 hours in a shared airspace, for a period of one week. Among the close contacts, a positive TST is defined as one with> 5 mm of induration after 5 UT of PPD placed intradermically using the Mantoux technique.
2. TST converters - which converted from documented negative to a positive TST within a period of two years. It is defined as a person with a Tuberculin dermal test> 10 mm within two years after a non-reactive test or a person with an increase of> 10 mm within a period of two years.
3. HIV seropositive people, positive TST (> 5 mm induration).
4. People with> 2 cm * of parenchymal pulmonary fibrosis on chest radiography, no previous history of TB treatment,> 5 mm of induration in TST, and 3 sputum cultures negative for M. tuberculosis in the final report.
5. Children> 2 but <5 years of age with> 10 mm induration in TST, regardless of the history of TB exposure.
• Close HIV-seropositive contacts of people with culture-confirmed TB, regardless of the condition of TST. In addition, close HIV-seropositive contacts of people with culture-confirmed TB who have a documented history of having completed a course of treatment suitable for active TB infection or latent TB are also eligible.
• Children> 2 but <5 years of age with a negative initial TST who are close contacts of a culture-confirmed case of TB.
• Desire to provide signed informed consent, or parental consent and participant acceptance.

Exclusion Criteria

• Current TB confirmed with culture-positive or by clinical criteria
• Suspicion of TB (as defined by the site researcher) or Isoniazid or rifampicin resistant tuberculosis in the source case
• A history of treatment for> 14 consecutive days with a rifamycin or> 30 consecutive days with INH during the previous 2 years.
• A documented history of having completed a course of treatment suitable for active TB or latent TB infection in a person who is HIV-seronegative.
• History of susceptibility / intolerance to isoniazid or rifamycins.
• Serum aspartate aminotransferase (AST, SGOT)> 5x the upper normal limit between people who were determined AST.
• Pregnant or lactating women.
• People who currently receive or plan to receive anti-retroviral therapy (eg, HIV 1 protease inhibitors, nucleoside or non-nucleoside reverse transcriptase inhibitors, CCR5 inhibitors or integrase inhibitors) in the first 90 days after enrollment.
• Weight <10.0 kilograms

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br>Outcome name:Through the cultivation or clinical evaluation of signs and symptoms<br>Measure:Development of culture-confirmed tuberculosis in people> 18 years and the development of culture-confirmed or probable (clinical) tuberculosis in people <18 years of age.<br>Timepoints:During the study<br>

Secondary Outcome Measures

Name	Time	Method
<br>Outcome name:Through the cultivation or clinical evaluation of signs and symptoms<br>Measure:Development of combined culture-confirmed or probable tuberculosis (regardless of age).<br>Timepoints:During the study<br>;<br>Outcome name:Emergence of adverse events related to the study drug.<br>Measure:Development of any degree of toxicity 3 or 4 related to the drug.<br>Timepoints:During the study<br>;<br>Outcome name:Death event due to any cause<br>Measure:Death due to any cause (toxicity grade 5).<br>Timepoints:During the study<br>