Tests how dolutegravir and weekly TB preventive drugs work together in children with HIV

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for children living with HIV, from 4 weeks to under 12 years old, who have no sign of active TB. It studies how dolutegravir behaves in the body during TB prevention treatment.

Age

4 weeks to under 12 years

Sex

Girls and boys can both join.

Disease stage

Children living with HIV with no sign of active TB; negative TB test if one was done (other than the skin test).

Earlier treatment

Can be new to HIV treatment (ART) or already on it.

Main reasons for not taking part

• Serious abnormal blood test results (grade 3 or worse) for liver, bilirubin, neutrophils, platelets or creatinine
• Sudden breathing trouble or any illness that could point to undiagnosed TB or another opportunistic infection
• Taking a medicine that interacts with dolutegravir or rifapentine
• Weight under 4 kilograms (9 lb (4 kg))

This trial only enrols participants living with HIV. The registry sentence this rests on: (1) ART-naïve or ART-experienced HIV-infected children 4 weeks to <12 years of age;

The registry criteria, word for word

What the trial wants to find out

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 examine and extend use of weekly rifapentine and isoniazid (3HP) among children receiving dolutegravir. This will address gaps in knowledge by examining two-way PK of short-course LTBI treatment in a vulnerable pediatric population.

The group in the trial

• Dolutegravir PK during weekly rifapentine/isoniazid for TB preventionTreatment being tested

  This is a single arm study: all patients are started on standard HIV treatment, with LTBI/TB prevention treatment varying according to age cohorts. Children 2-11 years receive standard weekly rifapentine/isoniazid (3HP) for TB prevention; those \<2 years received a single-dose of extrapolated weekly RPT/INH, followed by standard INH prophylaxis.

  Treatment: Rifapentine and Dolutegravir