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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00613379
Recruitment Status : Completed
First Posted : February 13, 2008
Results First Posted : May 31, 2013
Last Update Posted : July 15, 2016
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
CytoDyn, Inc.

Brief 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

Condition or disease Intervention/treatment Phase
HIV Infections Drug: PRO 140 Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : December 2007
Actual Primary Completion Date : August 2008
Actual Study Completion Date : August 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

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)

Experimental: Arm 2
5 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)

Primary Outcome Measures :
  1. 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).

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00613379

United States, New York
Progenics Pharmaceuticals, Inc
Tarrytown, New York, United States, 10591
Sponsors and Collaborators
CytoDyn, Inc.
National Institute of Allergy and Infectious Diseases (NIAID)
Study Director: Stephen Morris, MD, PhD Progenics Pharmaceuticals, Inc.

Additional Information:
Responsible Party: CytoDyn, Inc. Identifier: NCT00613379     History of Changes
Other Study ID Numbers: PRO 140 2301
1U19AI066329 ( U.S. NIH Grant/Contract )
First Posted: February 13, 2008    Key Record Dates
Results First Posted: May 31, 2013
Last Update Posted: July 15, 2016
Last Verified: June 2016

Keywords provided by CytoDyn, Inc.:
treatment naïve

Additional relevant MeSH terms:
Communicable Diseases
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
PRO-140 monoclonal antibody
HIV Antibodies
HIV Fusion Inhibitors
Viral Fusion Protein Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs