Study of PRO 140 by Subcutaneous Administration in Adult Subjects With HIV -1 Infection
This study has been completed.
Sponsor:
Progenics Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Progenics Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00642707
First received: March 21, 2008
Last updated: April 12, 2013
Last verified: April 2013
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Purpose
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
| Condition | Intervention | Phase |
|---|---|---|
|
HIV -1 Infection HIV Infections |
Drug: PRO 140 (humanized monoclonal antibody to CCR5) Drug: Placebo Comparator |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Genetics Home Reference related topics:
complement factor I deficiency
MedlinePlus related topics:
HIV/AIDS
U.S. FDA Resources
Further study details as provided by Progenics Pharmaceuticals, Inc.:
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). [ Time Frame: 59 days ] [ Designated as safety issue: No ]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).
| Enrollment: | 44 |
| Study Start Date: | March 2008 |
| Study Completion Date: | November 2008 |
| Primary Completion Date: | November 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Arm 1
PRO 140 for three single SC doses: Days 1, 8, and 15
|
Drug: PRO 140 (humanized monoclonal antibody to CCR5) |
|
Active Comparator: Arm 2
PRO 140 for three single SC doses: Days 1, 8 and 15
|
Drug: PRO 140 (humanized monoclonal antibody to CCR5) |
|
Active Comparator: Arm 3
PRO 140 for two single SC doses: Days 1 and 15 plus one SC dose of PBO at Day 8
|
Drug: PRO 140 (humanized monoclonal antibody to CCR5) |
|
Placebo Comparator: Arm 4
PBO for three single SC doses: Days 1, 8 and 15
|
Drug: Placebo Comparator |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00642707
Locations
| United States, New York | |
| Progenics Pharmaceuticals, Inc. | |
| Tarrytown, New York, United States, 10591 | |
Sponsors and Collaborators
Progenics Pharmaceuticals, Inc.
Investigators
| Study Director: | Stephen Morris, MD, PhD | Progenics Pharmaceuticals, Inc. |
More Information
Additional Information:
No publications provided
| Responsible Party: | Progenics Pharmaceuticals, Inc. |
| ClinicalTrials.gov Identifier: | NCT00642707 History of Changes |
| Other Study ID Numbers: | PRO 140 2101 |
| Study First Received: | March 21, 2008 |
| Results First Received: | April 12, 2013 |
| Last Updated: | April 12, 2013 |
| Health Authority: | United States: Food and Drug Administration United States: Institutional Review Board United States: National Institute of Health |
Keywords provided by Progenics Pharmaceuticals, Inc.:
|
HIV Treatment Naïve |
Additional relevant MeSH terms:
|
Acquired Immunodeficiency Syndrome HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases |
Slow Virus Diseases Immunologic Deficiency Syndromes Immune System Diseases Antibodies, Monoclonal Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 18, 2013