NCT00114699

Brief Summary

This is a phase 1, randomized, placebo-controlled, dose-escalation study of CCR5mAb004 in HIV-1 seropositive individuals who are not receiving concurrent antiretroviral therapy. Subjects will be randomly assigned to receive a single intravenous (IV) infusion of one of four dose levels of CCR5mAb004 or matching placebo. A minimum of 10 subjects will be randomized to each cohort at a ratio of 4:1 (active:placebo). A minimum of 40 and maximum of 60 subjects will be enrolled. This study will be conducted at up to 10 sites in the United States. Subjects in each cohort will be followed for 56 days after study agent administration. The safety, tolerability, and immunogenicity of CCR5mAb004 will be evaluated based on physical examination, adverse event (AE) reporting, and clinical laboratory tests. Blood will be collected at specified times for the determination of CCR5mAb004 serum concentrations, HIV-1 RNA levels, and CD4+ and CD8+ cell counts. If CD4+ cell counts are less than 200 during the study period, the subject should be offered standard-of-care per HIV treatment guidelines that may include the initiation of appropriate anti-retroviral therapy (AVR). CCR5mAb004 pharmacokinetic (PK) and pharmacodynamics (PD) will be measured over the 56-day study period. Anti-CCR5mAb004 antibody titers will be assessed prior to dosing on Day 0 and on Day 28 and Day 56.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P50-P75 for phase_1 hiv-infections

Timeline
Completed

Started Apr 2005

Geographic Reach
1 country

7 active sites

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

April 1, 2005

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 16, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 17, 2005

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2006

Completed
Last Updated

August 2, 2013

Status Verified

August 1, 2013

First QC Date

June 16, 2005

Last Update Submit

August 1, 2013

Conditions

HIV Infections

Keywords

HIVTreatment Naive

Outcome Measures

Primary Outcomes (1)

  • The major safety endpoints are AE rates and laboratory abnormalities through Day 56.

Secondary Outcomes (1)

  • The efficacy endpoints include change from baseline HIV-1 RNA levels (including viral kinetics) through Day 56, and change from baseline CD4+ and CD8+ cell counts through Day 56.

Interventions

CCR5mAb004DRUG

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • HIV-1 infection confirmed by enzyme immunoassay (EIA) and Western blot.
  • Age 18 to 64 years.
  • HIV-1 RNA \> 5000 copies/mL.
  • CD4+ T cell count \> 250 cells/uL.
  • Treatment naïve, or off antiretroviral treatment for at least 30 days prior to screening and 60 days prior to Day 0
  • CCR5 tropism confirmed by R5 PhenoSense assays.

You may not qualify if:

  • CXCR4 tropic or dual tropic virus at screening.
  • Laboratory values of Grade 3 or greater according to the Modified Division of Microbiology and Infectious Diseases (DMID) Adult Toxicity Tables.
  • History of Category C AIDS-defining illness according to the 1993 Centers for Disease Control and Prevention (CDC) AIDS surveillance definition.
  • History of any medical disease or condition that makes the subject (in the opinion of the investigator) unsuitable for the study.
  • Malignancy within the past 5 years (except for basal carcinomas of the skin and in situ cancers of the cervix).
  • Females who are pregnant or breastfeeding, or who plan to become pregnant during the study.
  • Subjects whose dosage or number of prescription medications has changed within 30 days prior to screening
  • Positive for hepatitis B surface antigen (HBsAg) or antibody to hepatitis C virus (HCV).
  • Positive alcohol or drug screen

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

AIDS Research Alliance

Los Angeles, California, United States

Location

Quest Clinical Research

San Francisco, California, United States

Location

Unknown Facility

Fort Lauderdale, Florida, United States

Location

The Orlando Immunology Center

Orlando, Florida, United States

Location

Johns Hopkins Hospital

Baltimore, Maryland, United States

Location

University Hospitals of Cleveland

Cleveland, Ohio, United States

Location

OSU Medical Center

Columbus, Ohio, United States

Location

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

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

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 16, 2005

First Posted

June 17, 2005

Study Start

April 1, 2005

Study Completion

April 1, 2006

Last Updated

August 2, 2013

Record last verified: 2013-08

Locations

US(7)