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

Official 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”

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

Intervention(s) in this Clinical Trial

• Drug: PRO 140 (humanized monoclonal antibody to CCR5)
• Drug: Placebo Comparator

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: Arm 1
  • PRO 140 for three single SC doses: Days 1, 8, and 15
• Active Comparator: Arm 2
  • PRO 140 for three single SC doses: Days 1, 8 and 15
• Active Comparator: Arm 3
  • PRO 140 for two single SC doses: Days 1 and 15 plus one SC dose of PBO at Day 8
• Placebo Comparator: Arm 4
  • PBO for three single SC doses: Days 1, 8 and 15

Primary Measures

• Maximum change in viral load following initiation of treatment.
  • Time Frame: 59 days
    Safety Issue?: Yes

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+ lymphocyte cell count ≥ 300 cells/mm3 and no documented count < or = 250 cells/mm3
• 4. Has not taken any antiretroviral 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, including
• PRO 140, experimental or approved.
• 5. Any immunization or vaccination (including influenza vaccine) within 30 days prior to administration of study drug.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Progenics Pharmaceuticals, Inc. Industry

Overall Clinical Trial Officials and Contacts

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

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00642707

Study ID Number: PRO 140 2101

ClinicalTrials.gov Identifier: NCT00642707

Health Authority: United States: Food and Drug Administration