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OpenTrials
Completed

NCT Number: NCT00642707

Study of PRO 140 by Subcutaneous Administration in Adult Subjects With HIV -1 Infection

The purpose of this study is:

1. To assess the antiviral activity of PRO 140 2. To assess the safety and tolerability of PRO 140 3. To generate additional PK, PD and safety data of PRO 140

Completed

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Key information

Conditions

HIV -1 Infection Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections 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+ lymphocyte cell count ≥ 300 cells/mm3 and no documented count < or = 250 cells/mm3
  • Has not taken any antiretroviral 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, including PRO 140, experimental or approved.
  • Any immunization or vaccination (including influenza vaccine) within 30 days prior to administration of study drug.

Treatment and study plan

PRO 140 (humanized monoclonal antibody to CCR5)

Drug

placebo comparator

Drug

Primary outcomes

  1. Maximum Change in Viral Load Following Initiation of Treatment (Viral Load is Defined as HIV-1 Copies/mL and Expressed as log10 Copies/mL).

    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

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Mar 25, 2008
Registry last updated
Jan 14, 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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