Last updated on February 2017

Study of PRO 140 SC as Single Agent Maintenance Therapy in Virally Suppressed Subjects With CCR5-tropic HIV-1 Infection


Brief description of study

This study is a Phase 2b/3, multi-center study designed to evaluate the efficacy, safety, and tolerability of the strategy of shifting clinically stable patients receiving suppressive combination antiretroviral therapy to PRO 140 monotherapy and maintaining viral suppression for 48 weeks following study entry. Consenting patients will be shifted from combination antiretroviral regimen to weekly PRO 140 monotherapy for 48 weeks during the Treatment Phase with the one week overlap of existing retroviral regimen and PRO 140 at the beginning of the study treatment and also one week overlap at the end of the treatment in subjects who do not experience virologic failure.

Detailed Study Description

The primary objective is to assess the treatment strategy of using PRO 140 SC as long-acting, single-agent maintenance therapy for the chronic suppression of CCR5-tropic HIV-1 infection. In addition, the prognostic factors of therapeutic success of PRO 140 monotherapy will be evaluated. The secondary objective of the trial is to assess the clinical efficacy, safety and tolerability parameters following substitution of combination antiretroviral therapy with weekly PRO 140 monotherapy.

Clinical Study Identifier: NCT02859961

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Thuy Pham

eStudySite
La Mesa, CA United States
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Erik Hernandez

Palmtree Clinical Research
Palm Springs, CA United States
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Adrienne Moran

Quest Clinical Research/eStudy
San Francisco, CA United States
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Laurie Andrews

Yale University
New Haven, CT United States
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Greg Ulrich

Circle CARE Center
Norwalk, CT United States
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Brenda Jacobs

Midway Immunology and Research Center
Fort Pierce, FL United States
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Janiza Veloz

Orlando Immunology Center
Orlando, FL United States
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Whitney Schneider

Triple O Research Institute, P.A.
West Palm Beach, FL United States
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Sheila Stauffer

Via Christi Research
Wichita, KS United States
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Melissa McManus

eStudySite
Las Vegas, NV United States
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Lynne Bartell

Chelsea Village Medical
New York, NY United States
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Kelly Bartlett

SUNY Upstate Medical University
Syracuse, NY United States
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