P1115 (DAIDS ID 11954): Very Early Intensive Treatment of HIV-Infected Infants to Achieve HIV Remission: A Phase I/II Proof of Concept Study

Study Status Study Restriction

Enrolling

US & Non-US

What is P1115?

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.

Study documents:

Other study implementation documents

Study trainings:


P1115 Training Brazil - November 2015

Sites where the study is implemented:

CRS ID Site Name City Country

5082

Hospital General de Agudos Buenos Aires Argentina NICHD CRS

Buenos Aires

Argentina

5119

Fundacion Huesped, Hospital Juan A Fernandez NICHD CRS

Buenos Aires

Argentina

5071

Inst of Pediatrics Fed Univ Rio de Janeiro NICHD CRS

Rio de Janeiro

Brazil

5072

Hospital dos Servidores Rio de Janeiro

Rio de Janeiro

Brazil

5073

SOM Federal University Minas Gerais Brazil

Minas Gerais

Brazil

5074

Univ of Sao Paulo Brazil

Sao Paulo

Brazil

5097

Hosp. Geral De Nova Iguacu Brazil NICHD CRS

Rio de Janeiro, Rio de Janeiro

Brazil

5117

Hospital Nossa Senhora da Conceicao CRS

Porto Alegre

Brazil

30022

Les Centres GHESKIO Clinical Research Site (GHESKIO-INLR) CRS

Port-au-Prince

Haiti

31441

BJ Medical College CRS

Pune, Maharashtra

India

5121

The Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc.

Kericho

Kenya

12001

University of North Carolina Lilongwe CRS

Lilongwe

Malawi

30301

College of Medicine JHU CRS

Blantyre

Malawi

8051

Shandukani Research CRS

Johannesburg

South Africa

8052

Soweto IMPAACT CRS

Johannesburg

South Africa

8950

Stellenbosch University

Cape Town

South Africa

30300

CAPRISA Umlazi Clinical Research Site (UKZN)

Umlazi, KwaZulu-Natal

South Africa

5118

Kilimanjaro Christian Medical CRS

Moshi

Tanzania

5120

MUHAS University of Health and Allied Sciences (Dartmouth), Dar es Salaam

Dar es Salaam

Tanzania

5115

Siriraj Hospital Mahidol University CRS

Bangkok

Thailand

5116

Chiang Rai Regional Hospital CRS

Muang

Thailand

30293

Makerere University - Johns Hopkins University (MU-JHU) Research Collaboration

Kampala

Uganda

31798

Baylor-Uganda CRS

Kampala

Uganda

3801

Texas Childrens Hosp. CRS

Houston

United States of America

4001

Chicago Children's CRS

Chicago

United States of America

4201

University of Miami Pediatric/Perinatal HIV/AIDS

Miami

United States of America

4601

UCSD Mother-Child-Adolescent HIV Program

San Diego

United States of America

5011

Boston Medical Center Pediatric HIV Program

Boston

United States of America

5013

Jacobi Medical Center Bronx

Bronx

United States of America

5017

Univ of Washington Children's Hospital Seattle

Seattle

United States of America

5030

Emory University School of Medicine NICHD CRS

Atlanta

United States of America

5031

San Juan City Hospital

San Juan

United States of America

5040

SUNY Stony Brook

Stony Brook

United States of America

5048

University of Southern California LA

Los Angeles

United States of America

5051

University of Florida Jacksonville

Jacksonville

United States of America

5052

University of Colorado Denver NICHD CRS

Aurora

United States of America

5055

South Florida CDTC Ft Lauderdale NICHD CRS

Fort Lauderdale

United States of America

5083

Rush University Cook County Hospital Chicago NICHD CRS

Chicago

United States of America

5092

Johns Hopkins University, Baltimore

Baltimore

United States of America

5112

UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CR

Los Angeles

United States of America

5112

David Geffen School of Medicine at UCLA

Los Angeles

United States of America

5113

The Children's Hospital of Philadelphia

Philadelphia

United States of America

5114

Bronx-Lebanon Hospital IMPAACT

Bronx

United States of America

6601

University of Puerto Rico Pediatric HIV/AIDS Research Program CRS

San Juan

United States of America

30273

George Clinic CRS

Lusaka

Zambia

30303

St. Mary's CRS (Zimbabwe)

Chitungwiza

Zimbabwe

30306

Seke North CRS (Zimbabwe)

Harare

Zimbabwe

31890

Harare Family Care CRS

Harare

Zimbabwe

Study contacts:

Study Co-Chair: Yvonne Bryson

Study Co-Chair: Ellen Chadwick

Study Vice-Chair: Mark Cotton

DAIDS Medical Officer: Patrick Jean-Philippe

NICHD Medical Officer: Rohan Hazra

Clinical Trials Specialist: Anne Coletti

Clinical Trials Specialist: Charlotte Perlowski

CAB representative: Marie Theunissen

DAIDS Protocol Pharmacist: Michelle Wildman

Data Manager: Amanda Zadzilka

Data Manager: Bonnie Zimmer

Field Representative: Chivon McMullen-Jackson

Immunologist: Katherine Luzuriaga

Investigator: Theodore Ruel

Laboratory Specialist: Diane Costello

Laboratory Specialist: Sarah Santos

Laboratory Specialist: Carolyn Yanavich

Laboratory Technologist: Cheryl Jennings

Pharmacologist: Edmund Capparelli

Pharmacologist: Mark Mirochnick

Statistician: Min Qin

Statistician: Camlin Tierney

Virologist: Deborah Persaud

Westat Representative: Scott Watson

 

Funded by the National Institute of Allergy and Infectious Diseases, the Eunice Kennedy Shriver National Institute of Child Health and Human Development, and the National Institute of Mental Health of the US National Institutes of Health, US Department of Health and Human Services.