2017 Annual Meeting Presentations

Watch

Sharon Nachman, MD

Behavioral and Social Science in Biomedical HIV Research

Michael Stirratt, PhD

Mary Jane Rotheram, PhD

Turning the Corner on the AIDS Pandemic: Refining the Science-Driven HIV Research Enterprise

Carl Dieffenbach, PhD

James Arthos, PhD

Brad Jones, PhD

Long-acting Methods

Raphael Landovitz, MD, Msc

• PROMISE 1077BF Update and Safety Findings
• Safety Update: Impact of tenofovir-containing triple antiretroviral therapy (ART) on bone mineral density in HIV-infected breastfeeding women in sub-Saharan Africa
• Hepatotoxicity in HIV+ Postpartum Women Initiating Efavirenz-Containing Regimensin PROMISE P1077

Mary Glenn Fowler, MD
Lynda Stranix-Chibanda, MD
Amita Gupta, MD, MHS

• Multi-stage Enrollment in Clinical Trials: Benefits vs. Potential Costs
• Assessing Risk: Benefit

Terence Fenton, EdD

Welcome, year in review and goals

PROMISE 1077BF: Breastfeeding Version of the PROMISE Study: Promoting Maternal and Infant Survival Everywhere

Pamela Murnane

IMPAACT 2009: Feasibility, Acceptability and Safety of Oral Pre-Exposure Prophylaxis for Primary HIV Prevention during Pregnancy and Breast Feeding in Adolescents and Young Women

Sybil Hosek

IMPAACT 2017: Phase I/II Study of the Safety, Acceptability, Tolerability, and Pharmacokinetics of Oral and Long-Acting Injectable Cabotegravir and Long-Acting Injectable Rilpivirine in Virologically Suppressed HIV-Infected Children and Adolescents

A5300B/IMPAACT 2003B – PHOENix MDR TB: Protecting Households on Exposure to Newly Diagnosed Index Multidrug-Resistant TB Patients

IMPAACT 2010/VESTED: Phase III Study of the Virologic Efficacy and Safety of Dolutegravir-Containing versus Efavirenz-Containing Antiretroviral Therapy Regimens in HIV-1-Infected Pregnant Women and their Infants

Key Updates and Operational Updates

• Financial Disclosures
• Protocol Deviations

IMPAACT Ops Representatives:
Kat Calabrese
Katie McCarthy

IMPAACT Site Overviews

• BJMC, India (31441)
• Hosp. Geral De Nova Igaucu, Brazil (5097)
• GHESKIO, Haiti (30022)

Sadaf Inamdar
Jorge Pilotto
Vanessa Rouzier

Welcome and Overview of Tuberculosis Scientific Agenda

PHOENIx (A5300/IMPAACT 2003): Study of MDR TB Cases and Their Household Contacts: Operational Feasibility to Inform PHOENIx Trial Design

Amita Gupta

IMPAACT 2001: Trial of the Pharmacokinetics, Tolerability, and Safety of Once-Weekly Rifapentine and Isoniazid in HIV-infected and HIV-1-uninfected Pregnant and Postpartum Women with Latent Tuberculosis Infection

Jyoti Mathad

P1108: A Phase I/II, Open-Label, Single Arm Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Bedaquiline (BDQ) in Combination with Optimized Individualized Multidrug-Resistant Tuberculosis (MDR-TB) Therapy in HIV-Infected and HIV-Uninfected Infants, Children and Adolescents with MDR-TB Disease

Anneke Hesseling

IMPAACT 2005: A Phase I/II Open-label, Single-Arm Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Delamanid in Combination with Optimized Multidrug Background Regimen (OBR) for Multidrug-Resistant Tuberculosis (MDR-TB) in HIV-infected and HIV-uninfected Children with MDR-TB

Ethel Weld

SMaRT Kids, the Adult MDR-TB Trials Landscape and Moving Pediatric TB Trials Forward

Tony Garcia-Prats

Emerging Data on Delaminid Pharmacokinetics and Safety in Children with MDR-TB

Jeffrey Hafkin

Using Pharmacokinetic Modelling to Evaluate Novel TB Drugs in Children More Efficiently: Experiences from BDQ CRUSH, P1108 and IMPAACT 2005

Elin Svensson

Update on Phenotypic and NGS-based Advances for Drug Susceptibility Testing and Their Use in Context of Clinical Trials

Marco Schito

Quantification of Circulating Mtb Antigen Peptides for Rapid Diagnosis and Treatment Monitoring

Tony Hu

Novel Blood-based Biomarkers for Pediatric TB

Jeff Tornheim
Mandar Paradkar

Katherine Luzuriaga

Effect of very early ART and therapeutic vaccines on reservoir size and viral rebound in non-human primates

Afam Okoye

Pediatric experience with ART interruption: what’s to fear?

William Borkowsky

Considerations for ART interruption in African infants participating in P1115

Mutsa Bwakura-Dangarembizi

Neurovirology of HIV Infection: New Directions for Clinical Research

Avi Nath

Update on IMPAACT NWCS 604 (Early Investigator Award)

David Bearden

Update on IMPAACT P1104s/ PROMISE (1077BF)/ Neurodevelopmental sub-study findings

Michael Boivin
Miriam Chernoff

Update on IMPAACT 2002: Combined Cognitive Behavioral Therapy and a Medication Management Algorithm for Treatment of Depression among Youth Living with HIV in the United States

Larry Brown

Update on IMPAACT 2016: Evaluating a Group-Based Intervention to Improve Mental Health and ART Adherence in Adolescents Living with HIV in Low Resource Settings

Geri Donenberg

Cardiovascular Complications of HIV Infection? Lessons learned from other inflammatory conditions in children and adolescents

Elaine Urbina

IMPAACT P1072 Secondary Analysis Results

Adriana Weinberg

Updates on RSV Studies: IMPAACT 2011, 2012, 2013

Betsy McFarland
Coleen Cunningham

Welcome and Overview of Treatment Scientific Agenda

Maternal and Infant Health Outcomes in the Context of Universal Antiretroviral Treatment

Pharmacokinetics/Pharmacodynamics and Safety of ARVs During Pregnancy

Brookie Best

Pharmacokinetics/Pharmacodynamics and Safety of ARVs During Breastfeeding

Edmund Capparelli

IMPAACT 2010/VESTED: Phase III Study of the Virologic Efficacy and Safety of Dolutegravir-Containing versus Efavirenz-Containing Antiretroviral Therapy Regimens in HIV-1-Infected Pregnant Women and their Infants

P1026s: Pharmacokinetic Properties of Antiretroviral Therapy During Pregnancy

Mark Mirochnick

P1093: Phase I/II, Multi-Center, Open-Label Pharmacokinetic, Safety, Tolerability and Antiviral Activity of GSK1349572 (Dolutegravir), a Novel Integrase Inhibitor, in Combination Regimens in HIV-1 Infected Infants, Children and Adolescents

Ted Ruel

P1101: Phase I/II Dose-Finding, Safety, Tolerance, & PK Study of Raltegravir-Containing ART Regimen in HIV-Infected & TB Co-Infected Children

Tammy Meyers

P1106: Pharmacokinetic Characteristics of Antiretrovirals and Tuberculosis Medicines in Low Birth Weight Infants

Adrie Bekker

P1097: Raltegravir Pharmacokinetics and Safety in Neonates; and P1110: A Phase I Trial to Evaluate the Safety and Pharmacokinetics of Raltegravir in HIV-Exposed Infants at High Risk

Diana Clarke

IMPAACT 2007: Phase I Safety & Pharmacokinetics of Maraviroc in HIV-1-Exposed Neonates at Risk of Acquiring HIV-1 Infection

Ellen Chadwick

IMPAACT 2014: Phase I/II Trial of PK, Safety, & Tolerability of Doravirine & Doravirine/3TC/TDF in HIV-1-Infected Children & Adolescents

Ann Melvin

IMPAACT 2017: Phase I/II Study of Safety & PK of Oral & Long-acting Injectable Cabotegravir & Rilpivirine in Virologically Suppressed HIV-Infected Adolescents

Carolyn Bolton

Modelling HIV Prevention Modalities for Children

Andrea Ciaranello

Study update for IMPAACT 2009: Feasibility, Acceptability and Safety of Oral Pre-Exposure Prophylaxis for Primary HIV Prevention during Pregnancy and Breast Feeding in Adolescents and Young Women

Sybil Hosek

Study update for IMPAACT P1112: Phase I Study to Determine Safety and Pharmacokinetic Parameters of Subcutaneous VRC01, a Potent Anti-HIV Neutralizing Monoclonal Antibody, in HIV-1 Exposed Infants

Coleen Cunningham

The Development of Broadly Neutralizing Antibodies in HIV-Infected Infants

Cassie Simonich
Julie Overbaugh

Pre-Clinical Infant HIV Vaccine Studies in Non-Human Primates

Kristina DeParis

Safety and Immunogenicity of HIV Vaccines in Infants

Giny Fouda