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A Randomized, Double-blind, Placebo-controlled Trial, Followed by Single-arm Treatment of PRO 140 in Combination w/ Optimized Background Therapy in Treatment-Experienced HIV Subjects

2015-06-29 07:12:21 | BioPortfolio

Summary

This is a Phase 2b/3, multi-center, two part study, designed to evaluate the efficacy, safety, and tolerability of PRO 140 in conjunction with existing ART (failing regimen) for one week and Optimized Background Therapy (OBT) for 24 weeks respectively. The patients population for this trial are treatment-experienced HIV-infected patients with CCR5-tropic virus and limited treatment options.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Conditions

HIV

Intervention

PRO 140, Placebo, Optimized Background Regimen

Status

Not yet recruiting

Source

CytoDyn, Inc.

Results (where available)

View Results

Links

Published on BioPortfolio: 2015-06-29T07:12:21-0400

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