The CAPRISA Clinical Trials: HIV Treatment and Prevention

Since its inception 14 years ago, CAPRISA has conducted numerous clinical studies that have influenced international TB-HIV treatment guidelines as well as HIV prevention through innovations in the microbicide and vaccine fields. This book provides a hist

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CAPRISA Clinical Trials: HIV Treatment and Prevention

The CAPRISA Clinical Trials: HIV Treatment and Prevention

Quarraisha Abdool Karim Salim S. Abdool Karim Cheryl Baxter •

Editors

The CAPRISA Clinical Trials: HIV Treatment and Prevention

123

Editors Quarraisha Abdool Karim CAPRISA University of KwaZulu-Natal Durban South Africa

Cheryl Baxter CAPRISA University of KwaZulu-Natal Durban South Africa

Salim S. Abdool Karim CAPRISA University of KwaZulu-Natal Durban South Africa

ISBN 978-3-319-47517-2 DOI 10.1007/978-3-319-47518-9

ISBN 978-3-319-47518-9

(eBook)

Library of Congress Control Number: 2016953917 © Springer International Publishing AG 2017 This work is subject to copyright. All rights are reserved by the Publisher, whether the whole or part of the material is concerned, specifically the rights of translation, reprinting, reuse of illustrations, recitation, broadcasting, reproduction on microfilms or in any other physical way, and transmission or information storage and retrieval, electronic adaptation, computer software, or by similar or dissimilar methodology now known or hereafter developed. The use of general descriptive names, registered names, trademarks, service marks, etc. in this publication does not imply, even in the absence of a specific statement, that such names are exempt from the relevant protective laws and regulations and therefore free for general use. The publisher, the authors and the editors are safe to assume that the advice and information in this book are believed to be true and accurate at the date of publication. Neither the publisher nor the authors or the editors give a warranty, express or implied, with respect to the material contained herein or for any errors or omissions that may have been made. Printed on acid-free paper This Springer imprint is published by Springer Nature The registered company is Springer International Publishing AG The registered company address is: Gewerbestrasse 11, 6330 Cham, Switzerland

Contents

Part I 1

2

3

Studies Linked to the Evolving HIV Epidemic in South Africa: Informing the CAPRISA Scientific Agenda . . . . . . . . . . . . . . . . . . . . Quarraisha Abdool Karim, Cheryl Baxter and Salim S. Abdool Karim

3

CAPRISA: Establishing a Research Centre to Undertake HIV Clinical Trials . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Salim S. Abdool Karim, Cheryl Baxter and Quarraisha Abdool Karim

15

Overview of Clinical Trials . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Anneke Grobler

Part II 4

5

6

7

Introduction/Background

27

CAPRISA Clinical Trials for HIV and HSV-2 Prevention

Antiretrovirals for HIV Prevention: The CAPRISA 004 Tenofovir Gel Trial . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Cheryl Baxter, Leila E. Mansoor, Tanuja N. Gengiah, Salim S. Abdool Karim and Quarraisha Abdool Karim

41

Rolling Out of Tenofovir Gel in Family Planning Clinics: The CAPRISA 008 Implementation Trial . . . . . . . . . . . . . . . . . . . . . Le