NCT00642707

Brief Summary

The purpose of this study is:

  1. 1.To assess the antiviral activity of PRO 140
  2. 2.To assess the safety and tolerability of PRO 140
  3. 3.To generate additional PK, PD and safety data of PRO 140

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Mar 2008

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2008

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

March 21, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 25, 2008

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2008

Completed
4.6 years until next milestone

Results Posted

Study results publicly available

May 31, 2013

Completed
Last Updated

January 14, 2016

Status Verified

December 1, 2015

Enrollment Period

8 months

First QC Date

March 21, 2008

Results QC Date

April 12, 2013

Last Update Submit

December 14, 2015

Conditions

HIV -1 InfectionHIV Infections

Keywords

HIVTreatment Naïve

Outcome Measures

Primary Outcomes (1)

  • 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).

    59 days

Study Arms (4)

Arm 1

ACTIVE COMPARATOR

PRO 140 for three single SC doses: Days 1, 8, and 15

Drug: PRO 140 (humanized monoclonal antibody to CCR5)

Arm 2

ACTIVE COMPARATOR

PRO 140 for three single SC doses: Days 1, 8 and 15

Drug: PRO 140 (humanized monoclonal antibody to CCR5)

Arm 3

ACTIVE COMPARATOR

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)

Arm 4

PLACEBO COMPARATOR

PBO for three single SC doses: Days 1, 8 and 15

Drug: Placebo Comparator

Interventions

PRO 140 (humanized monoclonal antibody to CCR5)DRUG
Arm 1Arm 2Arm 3
Placebo ComparatorDRUG
Arm 4

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Progenics Pharmaceuticals, Inc.

Tarrytown, New York, 10591, United States

Location

Related Publications (1)

  • 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.

    PMID: 20377413DERIVED

Related Links

MeSH Terms

Conditions

HIV Infections

Interventions

leronlimab

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Results Point of Contact

Title
Kush Dhody
Organization
CytoDyn, Inc.
kushd@amarexcro.com
301-956-2536

Study Officials

  • Stephen Morris, MD, PhD

    Progenics Pharmaceuticals, Inc.

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 21, 2008

First Posted

March 25, 2008

Study Start

March 1, 2008

Primary Completion

November 1, 2008

Study Completion

November 1, 2008

Last Updated

January 14, 2016

Results First Posted

May 31, 2013

Record last verified: 2015-12

Locations

US(1)