Adaption of an ongoing clinical trial to quickly respond to gaps in changing international recommendations: the experience of D 2 EFT

Author:

Papot Emmanuelle1ORCID,Jacoby Simone1,Arlinda Dona2,Avihingsanon Anchalee3,Azwa Iskandar4,Borok Margaret5,Brown Dannae6,Cissé Mohamed7ORCID,Dao Sounkalo8,Eriobu Nnakelu9,Kaplan Richard10,Karyana Muhammad2,Kumarasamy Nagalingeswaran11,Lee Johnnie12,Losso Marcelo H.13,Matthews Gail V.1,Perelis Leonardo13,Perez-Casas Carmen14,Ruxrungtham Kiat3,Watkins Melynda15,Lane H. Clifford16,Kelleher Anthony17,Law Matthew18,Polizzotto Mark N.119ORCID

Affiliation:

1. Therapeutic and Vaccine Research Program, The Kirby Institute, University of New South Wales Sydney, Sydney, NSW, Australia

2. Indonesia Research Partnership on Infectious Disease, Jakarta, Indonesia

3. The HIV Netherlands Australia Thailand Research Collaboration, Thai Red Cross AIDS Research Centre, Bangkok, Thailand

4. Infectious Diseases Unit, Department of Medicine, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia

5. University of Zimbabwe Clinical Research Centre, Harare, Zimbabwe

6. Global Medical, ViiV Healthcare, Abbotsford, Australia

7. Faculté des Sciences et techniques de la santé de l’Université Gamal Abdel Nasser de Conakry, University hospital of Donka, Conakry, Guinea

8. University Clinical Research Centre, Bamako, Mali

9. Institute of Human Virology, Abuja, Nigeria

10. Desmond Tutu Health Foundation, Cape Town, South Africa

11. Chennai Antiviral Research and Treatment Clinical Research Site, Infectious Diseases Medical Centre, Voluntary Health Services, Chennai, India

12. Global Medical Affairs, Global Public Health, Janssen Pharmaceutical companies of Johnson & Johnson, Plainfield, NJ, USA

13. Coordinación en Investigación Clínica Académica en Latinoamérica Fundación IBIS Buenos Aires, Buenos Aires, Argentina

14. Unitaid, Geneva, Switzerland

15. Product Development and Regulatory Affairs, Clinton Health Access Initiative, Boston, MA, USA

16. National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA

17. Immunovirology and Pathogenesis Program, The Kirby Institute, University of New South Wales Sydney, Sydney,Australia

18. Biostatistics and Databases Program, The Kirby Institute, University of New South Wales Sydney, Sydney,Australia

19. Department of Haematology, The Kinghorn Cancer Centre, St Vincent's Hospital, Darlinghurst, Australia

Funder

Unitaid

National Institutes of Health

National Health and Medical Research Council

ViiV Healthcare

ViiV Healthcare and Janssen donation

Publisher

Informa UK Limited

Reference36 articles.

1. World Health Organization. WHO Think-Tank Meeting on Optimizing Antiretroviral Therapy: Meeting Report . March 12 2020. https://apps.who.int/iris/rest/bitstreams/1327637/retrieve. Accessed March 18 2021.

2. The transition to dolutegravir and other new antiretrovirals in low-income and middle-income countries

3. World Health Organization. Treat All Implementation; 2019 . https://apps.who.int/iris/bitstream/handle/10665/326035/WHO-CDS-HIV-19.20-eng.pdf?ua=1. Accessed March 18 2021.

4. World Health Organization. HIV Drug Resistance Report 2021 . https://apps.who.int/iris/handle/10665/349340. Accessed March 18 2021.

5. World Health Organization. Guidelines Consolidated - Guidelines on the Use of Antiretroviral Drugs for Treating and Preventing HIV Infection - Recommandations for a Public Health Approach. Page 31 Chapter 4: Clinical Guidelines: Antiretroviral Therapy Table 4.11. WHO Definitions of Clinical Immunological and Virological Failure for the Decision to Switch ART Regimens . 2nd ed.; 2016. https://apps.who.int/iris/bitstream/handle/10665/208825/9789241549684_eng.pdf?sequence=1. Accessed August 18 2020.

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