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

• Sponsor: Human Genome Sciences Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00114699
• Collaborator: (none)
• Enrollment: 40
• Locations: 7
• Duration (Months): 12
• Patients Per Site: 5.7
• Patients Per Site Per Month: 0.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
HIV Infections	Drug: CCR5mAb004	Phase 1

Study Design

• Study Type: Interventional
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: Single
• Primary Purpose: Treatment
• 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
• Study Start Date: Apr 1, 2005
• Actual Study Completion Date: Apr 1, 2006

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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. []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 64 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	AIDS Research Alliance	Los Angeles	California	United States
2	Quest Clinical Research	San Francisco	California	United States
3		Ft. Lauderdale	Florida	United States
4	The Orlando Immunology Center	Orlando	Florida	United States
5	Johns Hopkins Hospital	Baltimore	Maryland	United States
6	University Hospitals of Cleveland	Cleveland	Ohio	United States
7	OSU Medical Center	Columbus	Ohio	United States

Sponsors and Collaborators

• Human Genome Sciences Inc.

Investigators

• Study Director: GSK Clinical Trials, GlaxoSmithKline

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Human Genome Sciences Inc.
• ClinicalTrials.gov Identifier: NCT00114699
• Other Study ID Numbers: CCR5-HV01
• First Posted: Jun 17, 2005
• Last Update Posted: Aug 2, 2013
• Last Verified: Aug 1, 2013

• Keywords provided by Human Genome Sciences Inc.: HIV; Treatment Naive
• Additional relevant MeSH terms: HIV Infections

Study Results

No Results Posted as of Aug 2, 2013