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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

About this trial

This is an interventional treatment trial for HIV -1 Infection focused on measuring HIV, Treatment Naïve

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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

NCT ID

NCT00642707

First Posted

March 21, 2008

Last Updated

December 14, 2015

Sponsor

CytoDyn, Inc.

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

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

Time Frame

59 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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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