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P1059 / Phase I Trial of Recombinant Vaccines in HIV+ Young Adults

A Phase I Open Label Study to Evaluate the Safety & Tolerability of Recombinant Vaccines in HIV-Infected Young Adults with Good Control of HIV-1 Replication and on Stable Highly Active Antiretroviral Therapy

Study Status

Concluded

DAIDS Number

10051

IND Number

BB 12268

Summary

P1059 was Phase I, open-label study among HIV-infected youth receiving treatment in the United States.  The study was designed to determine the safety and tolerability of recombinant MVA and Fowlpox HIV-1 vaccines in HIV-1-infected young adults with good control of HIV replication (HIV RNA < 100 copies/mL for 6 months) on stable antiretroviral therapy.

Study documents:

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20 November 2020

Study Chair

Study Vice-Chair

Data Manager

Drug Co. Representative

Investigator

Laboratory Technologist

Westat Representative

Abstracts

Safety and analyses of very low-level viremia during therapeutic HIV-1 immunizations in young adults on HAART: long-term persistence of dominant plasma clones derived from residual replication-competent virus in CD4+ T cells.

Conference

15th Conference on Retroviruses & Opportunistic Infections

Study

P1059

Authors

Carlum Shiu, Coleen K. Cunningham, Carrie Ziemniak, Petronella Muresan, Lawrence Fox, Aditya Gaur, Irma L. Febo Rodriguez, Katherine Luzuriaga, Deborah Persaud

Stability of Resting CD4+ T Cell HIV-1 Reservoirs following Immunization With Recombinant Poxvirus HIV-1 Vaccines

Conference

18th Conference on Retroviruses &amp; Opportunistic Infections

Study

P1059

Immunogenicity of recombinant modified vaccinia Ankara (MVA)-Fowlpox (FP) vaccines in HIV-1-infected young adults on suppressive HAART.

Conference

AIDS Vaccine 2007 International Conference

Study

P1059

Authors

Thomas C. Greenough, Coleen K. Cunningham, Margaret McManus, Lawrence Fox, Petronella Muresan, Deborah Persaud, Lynette Purdue, Mary Patricia Toye, Seydi Vazquez, Dennis Panicali, John L. Sullivan, Katherine Luzuriaga

Investigating genetic diversity and CTL escape burden in the replication-competent HIV reservoir in young adult participants of a historic therapeutic HIV vaccine trial

Conference

HIV Persistence Meeting

Study

P1059

Authors

Zabrina L. Brumme, Carrie Ziemniak, Hanwei Sudderuddin, Katherine Luzuriaga, Coleen Cunningham, Tom Greenough, Deborah Persaud

Increase in cell-associated infectivity following therapeutic immunization in HIV-1-infected young adults on suppressive HAART.

Conference

AIDS Vaccine 2007 International Conference

Study

P1059

Authors

Deborah Persaud, Carlum Shiu, Stephen J. Gange, Thomas C. Greenough, Kimberly Ferguson, Petronella Muresan, Carrie Ziemniak, Bryan M. Chesnick, Lawrence Fox, Dennis Panicali, Katherine Luzuriaga, Coleen K. Cunningham

Manuscripts

Identification of Ongoing Human Immunodeficiency Virus Type 1 (HIV-1) Replication in Residual Viremia during Recombinant HIV-1 Poxvirus Immunizations in Patients with Clinically Undetectable Viral Loads on Durable Suppressive Highly Active Antiretroviral

Carlum Shiu, Coleen K. Cunningham, Thomas C. Greenough, Petronella Muresan, Victor Sanchez Merino, Vincent J. Carey, Brooks Jackson, Carrie Ziemniak, Lawrence Fox, Marvin Eric Belzer, Stuart C. Ray, Katherine Luzuriaga, Deborah Persaud. Identification of Ongoing Human Immunodeficiency Virus Type 1 (HIV-1) Replication in Residual Viremia during Recombinant HIV-1 Poxvirus Immunizations in Patients with Clinically Undetectable Viral Loads on Durable Suppressive Highly Active Antiretroviral. Journal of Virology. 2010. 83: 9731-42.

Year

2010

Journal

Journal of Virology

Study

P1059