preventionofmalariaandhivdiseasein.docVIP

“PREVENTION OF MALARIA AND HIV DISEASE IN TORORO (PROMOTE)” A UCSF/MAKERERE UNIVERSITY COLLABORATION “PROMOTE-PIs (Pregnant women and Infants)” PROTEASE INHIBITORS TO REDUCE MALARIA MORBIDITY IN HIV-INFECTED PREGNANT WOMEN VERSION 4.0 Sponsored by: The National Institute of Child Health and Human Development (NICHD) Provision of Lopinavir/ritonavir by Abbott Laboratories Study Chair and Principal Investigator: Diane V. Havlir, MD University California San Francisco Study Vice-Chairs: Deborah Cohan, MD, MPH University California San Francisco Pius Okong, MMed, PhD Ugandan Ministry of Health Principal MU Investigator: Moses Kamya, MBChB, MMed, MPH Makerere University TABLE OF CONTENTS Page PROTOCOL TEAM ROSTER 7 GLOSSARY 10 SCHEMA 12 1.0 INTRODUCTION 14 1.1 Background 14 Table 1. Prevalence of maternal anemia according to HIV and malaria status at delivery 17 Table 2. Low birth weight according to maternal HIV and malaria status at delivery 18 Table 3. Risk of placental malaria among HIV-infected women receiving malaria IPT 20 1.2 Rationale 26 1.3 Antiretroviral Therapy 28 1.3.1 ART Programs in Uganda 28 1.3.2 ART agent: Efavirenz 28 1.3.3 ART agent: Lopinavir/ritonavir (Aluvia) 29 1.3.4 ART agent: Zidovudine (ZDV) 29 1.3.5 ART agent: Stavudine (d4T) 30 1.3.6 ART agent: Lamivudine (3TC) 30 1.3.7 ART agent: Tenofovir (TDF) 30 1.3.8 ART agent: Emtricitabine (FTC) 31 2.0 STUDY OBJECTIVES 31 2.1 Primary Objective 31 2.2 Secondary Objectives 31 3.0 STUDY DESIGN 33 Table 4. Treatment arms 33 4.0 SELECTION AND ENROLLMENT OF SUBJECTS 34 4.1 Inclusion criteria 34 4.2 Exclusion criteria 34 4.3 Identification and recruitment of study participants 35 4.4 Screening of potential study participants 36 4.5 Study informed consent 37 4.6 Enrollment and Baseline Evaluation 37 5.0 STUDY TREATMENT 38 5.1 Treatment Group Assignments 38 5.2 Treatment Allocation 39 5.3 Study Drug Dosing and Formul