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PRO 140 by IV Administration in Adults With HIV-1 Infection

NCT00613379 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2016-07-15

Study results available
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Summary

The purpose of this study is:

1. To assess and characterize the PK and PD of PRO 140 administered IV
2. To assess the antiviral activity of PRO 140
3. To assess the safety and tolerability of PRO 140

Conditions

  • HIV Infections

Interventions

DRUG

PRO 140

10 mg/kg PRO 140, one IV dose (N=10)

DRUG

PRO 140

5 mg/kg PRO 140, one IV dose (N=10)

DRUG

Placebo

PBO, one IV dose (N=10)

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    collaborator NIH

  • CytoDyn, Inc.

    lead INDUSTRY

Principal Investigators

  • Stephen Morris, MD, PhD · Progenics Pharmaceuticals, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-12-31
Primary Completion
2008-08-31
Completion
2008-08-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00613379 on ClinicalTrials.gov