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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00114699
Recruitment Status : Completed
First Posted : June 17, 2005
Last Update Posted : August 2, 2013
Information provided by (Responsible Party):
Human Genome Sciences Inc.

June 16, 2005
June 17, 2005
August 2, 2013
April 2005
Not Provided
The major safety endpoints are AE rates and laboratory abnormalities through Day 56.
Same as current
Complete list of historical versions of study NCT00114699 on Archive Site
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.
Same as current
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Safety and Efficacy of an Antibody to CCR5 in Individuals With HIV Who Are Not Currently on Antiretroviral Therapy
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

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.

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Phase 1
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single
Primary Purpose: Treatment
HIV Infections
Drug: CCR5mAb004
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
April 2006
Not Provided

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
Sexes Eligible for Study: All
18 Years to 64 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
United States
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Human Genome Sciences Inc.
Human Genome Sciences Inc.
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
Human Genome Sciences Inc.
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP