Dolutegravir Pharmacokinetics During Weekly Rifapentine/Isoniazid for TB Prevention
Recruiting
Phase 1
Interventional Study
Pediatric HIV Infection
Latent Tuberculosis
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 4 Weeks – 11
- Sex
- Any
- Trial phase
- Phase 1
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 25 (estimated)
- Sponsor
- Brigham and Women's Hospital · Other
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About This Trial
Tuberculosis (TB) is the leading cause of death among children living with HIV, yet insufficient data are available on the pharmacokinetics of newer TB prevention strategies in children. Short-course TB prevention/latent TB infection (LTBI) treatment regimens increase completion rates but have not been adequately studied among children living with HIV. Our prospective, open-label PK study will exa…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* (1) ART-naïve or ART-experienced HIV-infected children 4 weeks to \<12 years of age;
* (2) no evidence of active TB based on an appropriate clinical evaluation;
* (3) negative TB diagnostic test if performed (other than tuberculin skin testing);
* (4) weight of at least 4 kilo…
Contacts