Back to resultsPRO 140 by IV Administration in Adults With HIV-1 Infection
Primary Purpose
HIV Infections
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
PRO 140
PRO 140
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for HIV Infections 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+ 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.
Sites / Locations
- Progenics Pharmaceuticals, Inc
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
Arm 1
Arm 2
Arm 3
Arm Description
10 mg/kg PRO 140, one IV dose (N=10)
5 mg/kg PRO 140, one IV dose (N=10)
Placebo, one IV dose (N=10)
Outcomes
Primary Outcome Measures
Maximum Change in Viral Load Following Initiation of Treatment.
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
NCT ID
NCT00613379
First Posted
January 30, 2008
Last Updated
June 16, 2016
Sponsor
CytoDyn, Inc.
Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
1. Study Identification
Unique Protocol Identification Number
NCT00613379
Brief Title
PRO 140 by IV Administration in Adults With HIV-1 Infection
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 Type
Interventional
2. Study Status
Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
December 2007 (undefined)
Primary Completion Date
August 2008 (Actual)
Study Completion Date
August 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CytoDyn, Inc.
Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is:
To assess and characterize the PK and PD of PRO 140 administered IV
To assess the antiviral activity of PRO 140
To assess the safety and tolerability of PRO 140
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
HIV, treatment naïve
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm 1
Arm Type
Experimental
Arm Description
10 mg/kg PRO 140, one IV dose (N=10)
Arm Title
Arm 2
Arm Type
Experimental
Arm Description
5 mg/kg PRO 140, one IV dose (N=10)
Arm Title
Arm 3
Arm Type
Placebo Comparator
Arm Description
Placebo, one IV dose (N=10)
Intervention Type
Drug
Intervention Name(s)
PRO 140
Intervention Description
10 mg/kg PRO 140, one IV dose (N=10)
Intervention Type
Drug
Intervention Name(s)
PRO 140
Intervention Description
5 mg/kg PRO 140, one IV dose (N=10)
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
PBO, one IV dose (N=10)
Primary Outcome Measure Information:
Title
Maximum Change in Viral Load Following Initiation of Treatment.
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+ 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.
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
Links:
URL
http://www.progenics.com
Description
Former Sponsor website
URL
http://www.cytodyn.com/
Description
Sponsor Website
Learn more about this trial
PRO 140 by IV Administration in Adults With HIV-1 Infection
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