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Completed

NCT Number: NCT00613379

PRO 140 by IV Administration in Adults With HIV-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

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Key information

Conditions

HIV Infections Blood-Borne Infections Communicable Diseases Genital Diseases Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Progenics Pharmaceuticals, Inc

Tarrytown, New York, 10591, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Males & females, age ≥ 18 years (or minimum adult age as determined by local regulatory authorities)
  • Screening plasma HIV-1 RNA ≥ 5,000 copies/mL
  • CD4+ T-lymphocyte cell count ≥ 300 cells/mm3 and no documented count < or = 250 cells/mm3
  • Has not taken any anti-retroviral therapy (ART) w/in 12 wks of Early Screening Visit
  • Exclusive CCR5-tropic virus as determined by Trofile™ Assay at Early Screening Visit
  • Clinically normal or "not clinically significant (NCS)" resting electrocardiogram
  • 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

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

Treatment and study plan

PRO 140

Drug

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

Placebo

Drug

PBO, one IV dose (N=10)

Primary outcomes

  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).

Sponsors and collaborators

Lead sponsor

CytoDyn, Inc.

Industry

Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Feb 13, 2008
Registry last updated
Jul 15, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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