Ultra Curto (Ultra Short) TB Prevention Therapy

Tuberculosis Clinical Trial

Official title:

Safety and Tolerability of Ultra-short Course Rifapentine and Isoniazid (1HP) for Prevention of Tuberculosis in HIV-Uninfected Individuals

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04703075
• Other study ID #: IRB00284317
• Secondary ID: U01AI152961
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: March 24, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: March 2024
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

Tuberculosis (TB) is the leading infectious killer globally and a major cause of illness and suffering. The World Health Organization has prioritized TB preventive therapy (TPT) for people with latent TB infection (LTBI) as a key strategy for controlling the epidemic. Prevention of TB with isoniazid preventive therapy (IPT) is effective and reduces morbidity and mortality, and has been the mainstay of TB prevention for decades. But for an intervention with an excellent evidence of efficacy, global uptake has been abysmal. Completion rates for IPT when it is administered are poor (Gillespie 2008; Durovni 2010), with a large proportion of patients unable to complete treatment (McClintock 2017; Sterling 2011). While uptake is influenced by a variety of factors, a critical element has been the duration of IPT, with adherence falling sharply over time in clinical trials and practice. Shorter course regimens have a much higher completion rate and are more acceptable to patients, clinicians, and programs.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Tuberculosis

Intervention

Drug:
• Rifapentine 600 mg and INH 300 mg
Participants will receive Rifapentine 600 mg and INH 300 mg
• Rifapentine 900 mg and INH 900 mg
Participants will receive Rifapentine 900 mg and INH 900mg

Locations

Country	Name	City	State
Brazil	Fundacao de Medicina Tropical Doutor Heitor	Manaus	AM
Brazil	NAPDOT	Rio De Janeiro	RJ

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

Brazil, 

Outcome

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