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

June 16, 2016 updated by: CytoDyn, Inc.

A Phase 2a, Randomized, Double-Blind, Placebo-Controlled Study of PRO 140 by Intravenous Administration in Adult Subjects With Human Immunodeficiency Virus Type 1 Infection

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Tarrytown, New York, United States, 10591
        • Progenics Pharmaceuticals, Inc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Males & females, age ≥ 18 years (or minimum adult age as determined by local regulatory authorities)
  2. Screening plasma HIV-1 RNA ≥ 5,000 copies/mL
  3. CD4+ T-lymphocyte cell count ≥ 300 cells/mm3 and no documented count < or = 250 cells/mm3
  4. Has not taken any anti-retroviral therapy (ART) w/in 12 wks of Early Screening Visit
  5. Exclusive CCR5-tropic virus as determined by Trofile™ Assay at Early Screening Visit
  6. Clinically normal or "not clinically significant (NCS)" resting electrocardiogram
  7. Women of reproductive potential must have a negative serum pregnancy test at Late Screening Visit & a negative urine pregnancy test w/in 72 hrs prior to first dose of study medication, & be non-lactating. Male & female subjects must agree not to participate in a conception process from Early Screening Visit through Day 59.

Exclusion Criteria:

  1. CXCR4 tropic virus or dual/mixed tropic (R5X4) virus determined by the Trofile™ Assay.
  2. Females who are pregnant, lactating or breastfeeding, or who plan to become pregnant during the study.
  3. History of active hepatitis within the previous 24 wks
  4. Prior use of any entry, attachment, CCR5 co-receptor or fusion inhibitor, experimental or approved.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1
10 mg/kg PRO 140, one IV dose (N=10)
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)
Experimental: Arm 2
5 mg/kg PRO 140, one IV dose (N=10)
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)
Placebo Comparator: Arm 3
Placebo, one IV dose (N=10)
Drug: Placebo
PBO, one IV dose (N=10)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum Change in Viral Load Following Initiation of Treatment.
Time Frame: 59 days
The primary end point was the maximum change from baseline in viral load following initiation of treatment, defined as HIV-1 copies/mL, measured by the Roche Amplicor HIV-1 Monitor UltraSensitive™ Test (lower limit of detection [LLD] = 48 copies/mL).
59 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CytoDyn, Inc.

Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

  • Study Director: Stephen Morris, MD, PhD, Progenics Pharmaceuticals, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2007

Primary Completion (Actual)

August 1, 2008

Study Completion (Actual)

August 1, 2008

Study Registration Dates

First Submitted

January 30, 2008

First Submitted That Met QC Criteria

February 12, 2008

First Posted (Estimate)

February 13, 2008

Study Record Updates

Last Update Posted (Estimate)

July 15, 2016

Last Update Submitted That Met QC Criteria

June 16, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRO 140 2301
  • 1U19AI066329 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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