Tuberculosis Clinical Trial
Official title:
Safety and Tolerability of Ultra-short Course Rifapentine and Isoniazid (1HP) for Prevention of Tuberculosis in HIV-Uninfected Individuals
Verified date | March 2024 |
Source | Johns Hopkins University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
To compare treatment success (adherence and completion of treatment) and safety of 1HP with 3HP in HIV-uninfected adults and adolescents at increased risk of TB.
Status | Active, not recruiting |
Enrollment | 500 |
Est. completion date | December 31, 2024 |
Est. primary completion date | July 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 15 Years to 99 Years |
Eligibility | Inclusion Criteria: - Positive tuberculin skin test or interferon-gamma release assay (IGRA) test and - Household contact of an infectious TB case within previous 90 days, defined as sleeping at least once in a residence with a person diagnosed with pulmonary TB, or - Documented conversion of Tuberculin skin test (TST)/IGRA from negative to positive within 2 years Exclusion Criteria: - Documented HIV infection - Evidence of active tuberculosis on clinical exam or chest x-ray - Known intolerance of any study drug - Treatment for active or latent TB in the past for more than 14 days - Known close contact to someone with INH or rifampin resistant TB - Active liver disease or Aspartate aminotransferase(AST)/Alanine transaminase (ALT) >3 times upper limit of normal (ULN) - Neutropenia (ANC <1000) - Peripheral neuropathy >Grade 1 by DAIDS Grading Table - Pregnant or breastfeeding. Women of childbearing potential must agree to use non-hormonal contraception during study treatment. - Weight <40 kg |
Country | Name | City | State |
---|---|---|---|
Brazil | Fundacao de Medicina Tropical Doutor Heitor | Manaus | AM |
Brazil | NAPDOT | Rio De Janeiro | RJ |
Lead Sponsor | Collaborator |
---|---|
Johns Hopkins University | National Institute of Allergy and Infectious Diseases (NIAID) |
Brazil,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of participants who complete treatment with >90% adherence | To compare treatment success (completion of treatment with >90% adherence) of 1HP with 3HP in HIV-uninfected adults and adolescents at increased risk of TB. | 2 years |
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