TB Trials Consortium (TBTC)

Current study

Treatment of Latent TB infection: ASTERoiD (Assessment of the Safety, Tolerability, and Effectiveness of Rifapentine given Daily for latent TB infection [LTBI])

Summary: this study compares 6 weeks of daily rifapentine vs. a control arm of 12–16-week rifamycin-based treatment of LTBI and assess safety, tolerability, and effectiveness.

Eligibility criteria for the study:

• The inclusion criteria are:
  1. Age > 12 yrs. If females, non-pregnant
  2. Person with LTBI (with no history of treatment) that meet the following criteria
     1. Household and other contacts ( > 4 hours exposure in 1 week period) within 2 years prior to enrollment
        
     2. Converters within 2 years
        
     3. HIV co-infection
        
     4. >2 cm2 fibrosis on chest x-ray
        
     5. Recent immigration (within 2 years) to the US with abnormal chest x-ray and no evidence of active TB.
        
     6. Recent immigration ( within 2 years) to the US from country with an estimated incidence rate of TB > 150 per 100,000
        
     7. End stage renal disease
        
     8. On immunosuppressive medications such as steroids or TNF-α blockers
        
     9. HIV – infected person who are close contacts to TB case, regardless of TST or IGRA result
        
        
• Exclusion criteria are:
  1. A history of treatment for > 7 consecutive days with rifamycin or > 30 consecutive days with INH within 2 years
  2. Documented history of completing adequate course of treatment for TB disease or LTBI
  3. Weight < 25 Kg
  4. History of allergy or intolerance to rifamycins
  5. HIV- seropositive and on antiretroviral therapy that cannot be given with rifampin or rifapentine due to drug-drug interaction
  6. Females who are currently pregnant, breastfeeding or intend to become pregnant soon

Brief list of participation benefits

All participants will receive treatment for LTBI at no cost.

The time or other commitment required of the participants

Participants are expected to be in the study for 2 years.

During the study treatment phase, participants will be contacted at 2,4,6,8,12 & 16 weeks depending on what medication they are on.

During the follow-up phase, participants will be contacted 2 weeks after the last study dose, and then at 4, 6, 9, 12, 18 and 24 months.

While most of the study treatment phase evaluations will be in person, the follow up phase evaluations will be done over the phone.

The location of the research site:

The Public Health - Seattle & King County TB Clinic, located at Harborview Medical Center on the ground floor, East Clinic Wing, Room GEC -22.

The address is 325 9th Ave, Seattle, WA 98104
Phone: 206-744- 4579
Email: LTBI@kingcounty.gov

More information about this study can be found on the web at clinicaltrials.gov