PACTR202008554705202Not yet recruitingPhase 4
An open-label, sequential non-randomised pharmacokinetics study of dolutegravir (DTG) plasma exposure when given as twice or once daily DTG in the presence of rifampicin in children with Human Immune Deficiency Virus (HIV) and tuberculosis (TB) between 20-35kgs in South Africa. (Stage 1 using twice daily in accordance with the standard of care dosing).
Not provided0 sites20 target enrollmentStarted: July 23, 2020Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 4
- Status
- Not yet recruiting
- Enrollment
- 20
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 2 Year(s) to 5 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Children <18 years with confirmed HIV-1 infection weighing 20-35kg ART-naive or experienced, with plans to use DTG for HIV treatment
- •Diagnosis of TB disease with clinician initiating rifampicin-containing first-line therapy
- •Parents/legal guardians/caregivers and children give informed written consent (or assent, where applicable) to be in the study
- •Girls who have reached menses must have a negative pregnancy test at screening and be willing to adhere to two effective methods of contraception (barrier and a non-barrier form of contraception during the study, starting at least 14 days prior to enrolment) if sexually active. The parents/caregivers will be counselled together with the child if the child tests positive in order to reduce any social harm which may arise.
Exclusion Criteria
- •History or presence of known allergy or contraindications to DTG
- •Alanine aminotransferase (ALT) =5 times the upper limit of normal (ULN), OR ALT =3xULN and bilirubin =2xULN
- •Severe hepatic impairment or unstable liver disease (as defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminaemia, oesophageal or gastric varices, or persistent jaundice), known biliary abnormalities (except for Gilbert's syndrome or asymptomatic gallstones)
- •Pregnancy or breastfeeding
- •A concurrent illness that could influence drug PK, i.e. severe diarrhoea, vomiting, renal or liver disease
- •Treatment with concomitant medications known to have interactions with DTG
- •Participants that are eligible for the study but refuse to give consent and/or assent
Investigators
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