NCT00613379

Brief Summary

The purpose of this study is:

  1. 1.To assess and characterize the PK and PD of PRO 140 administered IV
  2. 2.To assess the antiviral activity of PRO 140
  3. 3.To assess the safety and tolerability of PRO 140

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for phase_2 hiv-infections

Timeline
Completed

Started Dec 2007

Shorter than P25 for phase_2 hiv-infections

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

December 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 30, 2008

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 13, 2008

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2008

Completed
4.8 years until next milestone

Results Posted

Study results publicly available

May 31, 2013

Completed
Last Updated

July 15, 2016

Status Verified

June 1, 2016

Enrollment Period

8 months

First QC Date

January 30, 2008

Results QC Date

April 12, 2013

Last Update Submit

June 16, 2016

Conditions

HIV Infections

Keywords

HIVtreatment naïve

Outcome Measures

Primary Outcomes (1)

  • 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).

    59 days

Study Arms (3)

Arm 1

EXPERIMENTAL

10 mg/kg PRO 140, one IV dose (N=10)

Drug: PRO 140

Arm 2

EXPERIMENTAL

5 mg/kg PRO 140, one IV dose (N=10)

Drug: PRO 140

Arm 3

PLACEBO COMPARATOR

Placebo, one IV dose (N=10)

Drug: Placebo

Interventions

PRO 140DRUG

10 mg/kg PRO 140, one IV dose (N=10)

Arm 1
PlaceboDRUG

PBO, one IV dose (N=10)

Arm 3

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+ 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.

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, experimental or approved.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Progenics Pharmaceuticals, Inc

Tarrytown, New York, 10591, United States

Location

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
Dr. Nader Pourhassan
Organization
Cytodyn, Inc.
npourhassan@cytodyn.com
360-980-8524

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
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 30, 2008

First Posted

February 13, 2008

Study Start

December 1, 2007

Primary Completion

August 1, 2008

Study Completion

August 1, 2008

Last Updated

July 15, 2016

Results First Posted

May 31, 2013

Record last verified: 2016-06

Locations

US(1)