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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

High TB incidence countries (TB rate of >150 cases per 100,000 population)

Data from World Health Organization (WHO) (estimates of tuberculosis incidence by country, 2015 and Global tuberculosis report 2016, accessed 15/11/2016).

Country/Territory Estimated rate per
100,000 population
Number of cases
Afghanistan 189 61,000
Angola 370 93,000
Bangladesh 225 362,000
Bhutan 155 1,200
Botswana 356 8,000
Cambodia 380 59,000
Cameroon 212 49,000
Central African Republic 391 19,000
Chad 152 21,000
Congo 379 18,000
Cote d'Ivoire 159 36,000
Democratic People's Republic of Korea 561 141,000
Democratic Republic of the Congo 324 250,000
Djibouti 378 3,400
Equatorial Guinea 172 1,500
Ethiopia 192 191,000
Gabon 465 8,000
Gambia 174 3,500
Ghana 160 44,000
Greenland 164 92
Guinea 177 22,000
Guinea-Bissau 373 6,900
Haiti 194 21,000
India 217 2,840,000
Indonesia 395 1,020,000
Kenya 233 107,000
Kiribati 551 620
Lao People's Democratic Republic 182 12,000
Lesotho 788 17,000
Liberia 308 14,000
Madagascar 236 57,000
Malawi 193 33,000
Marshall Islands 344 180
Mongolia 428 13,000
Mozambique 551 154,000
Myanmar 365 197,000
Namibia 489 12,000
Nepal 156 44,000
Nigeria 322 586,000
Pakistan 270 510,000
Papua New Guinea 432 33,000
Philippines 322 324,000
Republic of Moldova 152 6,200
Sierra Leone 307 20,000
Somalia 274 30,000
South Africa 834 454,000
Swaziland 565 7,300
Thailand 172 117,000
Timor-Leste 498 5,900
Tuvalu 232 23
Uganda 202 79,000
United Republic of Tanzania 306 164,000
Zambia 391 63,000
Zimbabwe 242 38,000