Safety and Efficacy of an Antibody to CCR5 in Individuals With HIV Who Are Not Currently on Antiretroviral Therapy - Full Text View

Sponsored by:	Human Genome Sciences
Information provided by:	Human Genome Sciences
ClinicalTrials.gov Identifier:	NCT00114699

Purpose

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.

Condition	Intervention	Phase
HIV Infections	Drug: CCR5mAb004	Phase I

MedlinePlus related topics: AIDS

Drug Information available for: Immunoglobulins Globulin, Immune

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Phase 1, Randomized, Placebo-Controlled, Single-Injection, Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Ccr5mab004 (Human Monoclonal Igg4 Antibody To Ccr5) in Hiv-1 Seropositive Individuals Who Are Not Receiving Concurrent Antiretroviral Therapy

Further study details as provided by Human Genome Sciences:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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.

Estimated Enrollment:	40
Study Start Date:	April 2005
Study Completion Date:	April 2006

Eligibility

Ages Eligible for Study:	18 Years to 64 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00114699

Locations

United States, California
AIDS Research Alliance
Los Angeles, California, United States
Quest Clinical Research
San Francisco, California, United States
United States, Florida
The Orlando Immunology Center
Orlando, Florida, United States

Ft. Lauderdale, Florida, United States
United States, Maryland
Johns Hopkins Hospital
Baltimore, Maryland, United States
United States, Ohio
University Hospitals of Cleveland
Cleveland, Ohio, United States
OSU Medical Center
Columbus, Ohio, United States

Sponsors and Collaborators

Human Genome Sciences

More Information

Study ID Numbers:	CCR5-HV01
Study First Received:	June 16, 2005
Last Updated:	December 10, 2007
ClinicalTrials.gov Identifier:	NCT00114699
Health Authority:	United States: Food and Drug Administration

Keywords provided by Human Genome Sciences:

HIV
Treatment Naive

Study placed in the following topic categories:

Virus Diseases
Antibodies
Sexually Transmitted Diseases, Viral
HIV Infections
Sexually Transmitted Diseases

Acquired Immunodeficiency Syndrome
Retroviridae Infections
Immunologic Deficiency Syndromes
Immunoglobulins

Additional relevant MeSH terms:

RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
Lentivirus Infections
Infection

ClinicalTrials.gov processed this record on January 16, 2009