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P1115

Very Early Intensive Treatment of Infants Living with HIV to Achieve HIV Remission: A Phase I/II Proof of Concept Study

Study Status

Enrolling

DAIDS Number

11954

IND Number

133,017

Clinical Trials Link

Primary Protocol Team Members

Marie Theunissen CAB representative
Nagawa Jaliaah CAB representative
Anne Coletti Clinical Research Manager
Charlotte Perlowski Clinical Research Manager
Jonathan Lucas Community Program Manager
Rochelle Rogers DAIDS Protocol Pharmacist
Carly Hoffmann Data Manager
Madison O'Brien Data Manager
Katherine Luzuriaga Immunologist
Elizabeth (Betsy) McFarland Immunologist
Diana Clarke Investigator
Stephen Spector Investigator
Theodore Ruel Investigator
Sarah Wojcinski Laboratory Data Manager (LDM)
Laura Hovind Laboratory Data Manager (LDM)
Diane Costello Laboratory Specialist
Cheryl Jennings Laboratory Technologist
Mark Mirochnick Pharmacologist
Edmund Capparelli Pharmacologist
Edward Acosta Pharmacologist
Camlin Tierney Statistician
Patricia DeMarrais Statistician
Bryan Nelson Statistician
Deborah Persaud Virologist
Scott Watson Westat Representative
Sai Majji NICHD Medical Officer
Jack Moye Jr. NICHD Medical Officer
Eric Lorenzo NICHD Medical Officer
Dwight Yin DAIDS Medical Officer
Patrick Jean-Philippe DAIDS Medical Officer
Yvonne Bryson Study Vice-Chair
Mark Cotton Study Vice-Chair

Summary

P1115 is a Phase I/II, multi-center, proof-of-concept study that will explore the effects of early intensive antiretroviral therapy on achieving HIV remission in neonates. The study will also assess the safety and pharmacokinetics of early intensive antiretroviral therapy in neonates.

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