Pharmacokinetics of Twice or Once Daily DTG (50mg) in Children With HIV and TB

Launched by UNIVERSITY OF KWAZULU · Feb 4, 2021

Keywords

ClinConnect Summary

This clinical trial is studying how well a medication called DTG (dolutegravir) works when given either once or twice a day to children who have both HIV and tuberculosis (TB). The main goal is to find out if a twice-daily dose of 50 mg is effective for children who weigh between 20 and 35 kilograms and are also receiving treatment for TB with a drug called rifampicin. Recently, the study was updated to include younger children weighing as little as 3 kilograms, who will receive a lower dose of 10 mg of DTG.

To participate in this trial, children must be under 18 years old, have a confirmed HIV infection, and be starting treatment for TB. Their parents or guardians must agree and provide written consent for them to be in the study. Participants can expect close monitoring by healthcare professionals to ensure their safety and well-being throughout the trial. It's important to note that children with certain health conditions or allergies, as well as those who are pregnant or breastfeeding, cannot take part in the study. This trial aims to improve treatment options for children dealing with both HIV and TB, helping to make their care more effective.

Gender

ALL

Eligibility criteria

• 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