Study of PRO 140 by Subcutaneous Administration in Adult Subjects With HIV -1 Infection
Primary Purpose
HIV -1 Infection, HIV Infections
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
PRO 140 (humanized monoclonal antibody to CCR5)
Placebo Comparator
Sponsored by
About this trial
This is an interventional treatment trial for HIV -1 Infection focused on measuring HIV, Treatment Naïve
Eligibility Criteria
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.
Sites / Locations
- Progenics Pharmaceuticals, Inc.
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Active Comparator
Active Comparator
Placebo Comparator
Arm Label
Arm 1
Arm 2
Arm 3
Arm 4
Arm Description
PRO 140 for three single SC doses: Days 1, 8, and 15
PRO 140 for three single SC doses: Days 1, 8 and 15
PRO 140 for two single SC doses: Days 1 and 15 plus one SC dose of PBO at Day 8
PBO for three single SC doses: Days 1, 8 and 15
Outcomes
Primary Outcome Measures
Maximum Change in Viral Load Following Initiation of Treatment (Viral Load is Defined as HIV-1 Copies/mL and Expressed as log10 Copies/mL).
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).
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00642707
Brief Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
November 2008 (Actual)
Study Completion Date
November 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CytoDyn, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is:
To assess the antiviral activity of PRO 140
To assess the safety and tolerability of PRO 140
To generate additional PK, PD and safety data of PRO 140
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV -1 Infection, HIV Infections
Keywords
HIV, Treatment Naïve
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
44 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm 1
Arm Type
Active Comparator
Arm Description
PRO 140 for three single SC doses: Days 1, 8, and 15
Arm Title
Arm 2
Arm Type
Active Comparator
Arm Description
PRO 140 for three single SC doses: Days 1, 8 and 15
Arm Title
Arm 3
Arm Type
Active Comparator
Arm Description
PRO 140 for two single SC doses: Days 1 and 15 plus one SC dose of PBO at Day 8
Arm Title
Arm 4
Arm Type
Placebo Comparator
Arm Description
PBO for three single SC doses: Days 1, 8 and 15
Intervention Type
Drug
Intervention Name(s)
PRO 140 (humanized monoclonal antibody to CCR5)
Intervention Type
Drug
Intervention Name(s)
Placebo Comparator
Primary Outcome Measure Information:
Title
Maximum Change in Viral Load Following Initiation of Treatment (Viral Load is Defined as HIV-1 Copies/mL and Expressed as log10 Copies/mL).
Description
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).
Time Frame
59 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen Morris, MD, PhD
Organizational Affiliation
Progenics Pharmaceuticals, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Progenics Pharmaceuticals, Inc.
City
Tarrytown
State/Province
New York
ZIP/Postal Code
10591
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
20377413
Citation
Jacobson JM, Thompson MA, Lalezari JP, Saag MS, Zingman BS, D'Ambrosio P, Stambler N, Rotshteyn Y, Marozsan AJ, Maddon PJ, Morris SA, Olson WC. Anti-HIV-1 activity of weekly or biweekly treatment with subcutaneous PRO 140, a CCR5 monoclonal antibody. J Infect Dis. 2010 May 15;201(10):1481-7. doi: 10.1086/652190.
Results Reference
derived
Links:
URL
http://www.progenics.com
Description
Related Info
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Study of PRO 140 by Subcutaneous Administration in Adult Subjects With HIV -1 Infection
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