PRO 140 for Human Immunodeficiency Virus Infection

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2015-02-28

Brief Summary

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PRO 140 2103 is a multicenter, randomized parallel group study, conducted in male and female adult subjects infected with CCR5-tropic HIV-1.

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Detailed Description

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Protocol PRO 140 2103 is a multicenter, randomized parallel group study, conducted in approximately 40 male and female adult subjects (n=10/treatment group) infected with CCR5-tropic HIV-1. Subjects will be randomized into one of four treatment groups. Blood samples for drug concentrations, PD variables, and efficacy variables will be obtained over a 59-day period following initiation of dosing. Safety will be monitored throughout the course of the study.

Conditions

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HIV

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment Arm 1

PRO 140: one SC dose, 350 mg (day 1), followed by two single SC doses, 350 mg each (days 8 and 15) Intervention: Drug: PRO 140 (humanized monoclonal antibody to CCR5)

Group Type ACTIVE_COMPARATOR