Publications by authors named "Shafic Makumbi"
Article Synopsis
- Dolutegravir (DTG) is metabolized in the body, producing an inactive form called DTG glucuronide (DTG-gluc), and the study focused on its metabolic ratio (DTG-MR) among 85 HIV-positive children aged 3 months to 18 years.
- The research found that the overall DTG-MR in children was similar to that in adults and was primarily influenced by the use of rifampicin, which significantly increased the DTG-MR.
- These results suggest that factors like age, body weight, and type of NRTI treatment do not affect the DTG-MR in children, paving the way for better pharmacokinetic modeling for pediatric patients based on adult data
Objectives: To examine the voluntariness of consent in paediatric HIV clinical trials and the associated factors.
Design: Mixed-methods, cross-sectional study combining a quantitative survey conducted concurrently with indepth interviews.
Setting And Participants: From January 2021 to April 2021, we interviewed parents of children on first-line or second-line Anti-retroviral therapy (ART) in two ongoing paediatric HIV clinical trials [CHAPAS-4 (ISRCTN22964075) and ODYSSEY (ISRCTN91737921)] at the Joint Clinical Research Centre Mbarara, Uganda.
Article Synopsis
- * Children were divided into groups to receive either emtricitabine/TAF or standard HIV treatments, with doses determined by their weight, and blood samples were analyzed for drug concentration.
- * Results showed that TAF levels in children were similar to those seen in adults, suggesting these treatments are effective and safe for young patients in Africa.
Background: Dolutegravir (DTG), combined with a backbone of 2 nucleoside reverse transcriptase inhibitors, is currently the preferred first-line treatment for human immunodeficiency virus (HIV) in childhood. CHAPAS4 is an ongoing randomized controlled trial investigating second-line treatment options for children with HIV. We did a nested pharmacokinetic (PK) substudy within CHAPAS4 to evaluate the DTG exposure in children with HIV taking DTG with food as part of their second-line treatment.
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- The study evaluated the dosing and safety of dolutegravir, a key HIV treatment, in young children weighing between 3 kg and 20 kg as part of the ODYSSEY trial.
- It included pharmacokinetic assessments and safety evaluations for 72 children from multiple research centers across South Africa, Uganda, and Zimbabwe, focusing on proper dosing based on weight.
- Results showed that 71 children were included in the safety analysis, with pharmacokinetic profiles generated for 55 children, potentially providing valuable data for dolutegravir use in this age group.
Background: Children with human immunodeficiency virus type 1 (HIV-1) infection have limited options for effective antiretroviral treatment (ART).
Methods: We conducted an open-label, randomized, noninferiority trial comparing three-drug ART based on the HIV integrase inhibitor dolutegravir with standard care (non-dolutegravir-based ART) in children and adolescents starting first- or second-line ART. The primary end point was the proportion of participants with virologic or clinical treatment failure by 96 weeks, as estimated by the Kaplan-Meier method.
Background: Paediatric dolutegravir doses approved by stringent regulatory authorities (SRAs) for children weighing 20 kg to less than 40 kg until recently required 25 mg and 10 mg film-coated tablets. These tablets are not readily available in low-resource settings where the burden of HIV is highest. We did nested pharmacokinetic substudies in patients enrolled in the ODYSSEY-trial to evaluate simplified dosing in children with HIV.
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