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5 results on '"Mhute, Tawanda"'

1. Once vs twice-daily abacavir and lamivudine in African children

Author

Musiime, Victor, Kasirye, Philip, Naidoo-James, Bethany, Nahirya-Ntege, Patricia, Mhute, Tawanda, Cook, Adrian, Mugarura, Lincoln, Munjoma, Marshall, Thoofer, Navdeep K., Ndashimye, Emmanuel, Nankya, Immaculate, Spyer, Moira J., Thomason, Margaret J., Snowden, Wendy, Gibb, Diana M., and Walker, Ann Sarah

Published
2016
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3. Ethical and legal constraints to children’s participation in research in Zimbabwe: experiences from the multicenter pediatric HIV ARROW trial

Author

Bwakura-Dangarembizi Mutsa, Musesengwa Rosemary, Nathoo Kusum J, Takaidza Patrick, Mhute Tawanda, and Vhembo Tichaona

Subjects
Medical philosophy. Medical ethics, R723-726
Abstract

Abstract Background Clinical trials involving children previously considered unethical are now considered essential because of the inherent physiological differences between children and adults. An integral part of research ethics is the informed consent, which for children is obtained by proxy from a consenting parent or guardian. The informed consent process is governed by international ethical codes that are interpreted in accordance with local laws and procedures raising the importance of contextualizing their implementation. Findings In Zimbabwe the parental informed consent document for children participating in clinical research is modeled along western laws of ethics and requires that the parent or legally authorized representative provide consent on behalf of a minor. This article highlights the experiences and lessons learnt by Zimbabwean researchers in obtaining informed consent from guardians of orphaned children participating in a collaborative HIV clinical trial involving the Medical Research Council, United Kingdom and four centers, three of which are in Uganda. Researchers were faced with a situation where caregivers of orphaned children were not permitted to provide informed consent for trial participation. The situation contrasted with general clinical practice where consent for procedures on orphans is obtained from their caregivers who are not legal guardians. Conclusion The challenges faced in obtaining informed consent for orphans in this clinical trial underscores the need for the Zimbabwe ethics committee to develop an ethical and legal framework for pediatric research that is based on international guidelines while taking into account the cultural context. The Medical Research Council of Zimbabwe has since started the process that is expected to involve critical stakeholders namely the community including children, ethicists, the legal fraternity and researchers.

Published
2012
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4. Once- versus twice-daily abacavir and lamivudine in African children: the randomised controlled ARROW Trial

Author

Musiime, Victor, Kasirye, Philip, Naidoo-James, Bethany, Nahirya-Ntege, Patricia, Mhute, Tawanda, Cook, Adrian, Mugarura, Lincoln, Munjoma, Marshall, Thoofer, Navdeep K, Ndashimye, Emmanuel, Nankya, Immaculate, Spyer, Moira J., Thomason, Margaret J., Snowden, Wendy, Gibb, Diana M., and Walker, A. Sarah

Subjects
Male, Adolescent, Drug-Related Side Effects and Adverse Reactions, Sustained Virologic Response, Anti-HIV Agents, Infant, HIV Infections, Article, Dideoxynucleosides, Medication Adherence, Immune Reconstitution, Treatment Outcome, Lamivudine, Child, Preschool, Africa, Drug Resistance, Viral, Humans, Female, Child
Abstract

Antiretroviral therapy (ART) adherence is critical for successful HIV treatment outcomes. Once-daily dosing could improve adherence. Plasma concentrations of once-daily vs twice-daily abacavir + lamivudine are bioequivalent in children, but no randomized trial has compared virological outcomes.Children taking abacavir + lamivudine-containing first-line regimens twice daily for more than 36 weeks in the ARROW trial (NCT02028676, ISRCTN24791884) were randomized to continue twice-daily vs move to once-daily abacavir + lamivudine (open-label). Co-primary outcomes were viral load suppression at week 48 (12% noninferiority margin, measured retrospectively) and lamivudine or abacavir-related grade 3/4 adverse events.Six hundred and sixty-nine children (median 5 years, range 1-16) were randomized to twice daily (n = 333) vs once daily (n = 336) after median 1.8 years on twice-daily abacavir + lamivudine-containing first-line ART. Children were followed for median 114 weeks. At week 48, 242/331 (73%) twice daily vs 236/330 (72%) once daily had viral load less than 80 copies/ml [difference -1.6% (95% confidence interval -8.4,+5.2%) P = 0.65]; 79% twice daily vs 78% once daily had viral load less than 400 copies/ml (P = 0.76) (week 96 results similar). One grade 3/4 adverse event was judged uncertainly related to abacavir + lamivudine (hepatitis; once daily). At week 48, 9% twice daily vs 10% once daily reported missing one or more ART pills in the last 4 weeks (P = 0.74) and 8 vs 8% at week 96 (P = 0.90). Carers strongly preferred once-daily dosing. There was no difference between randomized groups in postbaseline drug-resistance mutations or drug-susceptibility; WHO 3/4 events; ART-modifying, grade 3/4 or serious adverse events; CD4% or weight-for-age/height-for-age (all P 0.15).Once-daily abacavir + lamivudine was noninferior to twice daily in viral load suppression, with similar resistance, adherence, clinical, immunological and safety outcomes. Abacavir + lamivudine provides the first once-daily nucleoside backbone across childhood that can be used to simplify ART.

Published
2016

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