NCT00385567|TerminatedPhase 2DMC
Study Stopped
Difficulty recruiting eligible patients in timely fashion
A Trial of PEHRG214 in HIV-Infected Patients
A Phase 2 Randomized, Controlled Trial of PEHRG214 in HIV-Infected Patients
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Sponsor study identifier
interventional
70
2 countries
7
Study Start
January 2007
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
September 2008
Actual (reported)Study Completion
September 2008
Actual (reported)HRG2 is a Phase 2 randomized, controlled, open-label, multi-dose trial to determine the efficacy, safety, immunogenicity, and pharmacokinetic profile of PEHRG214 in HIV-infected patients, treated three times weekly for up to 16 weeks. All patients are receiving optimized standard of care HAART. The primary objective of the study is to determine the effect of PEHRG214 in decreasing the viral load (\>=1.0 log10), as compared to a Control group. The primary hypothesis is that treatment with PEHRG214 will result in clinically meaningful and sustained viral load suppression. The total sample size is 70-74 patients from approximately 8-10 participating study centers. The first 16-20 patients are enrolled in the non-randomized "pilot arm" and 54 subsequent patients are randomized (2:1 within center) to Treatment or Control group. The total study duration is 7-12 months.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 2008
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 1, 2006
Actual (reported)October 9, 2006
Actual (reported)January 2007
Date type not reportedThis date has not been verified as actual or estimated.
September 2008
Actual (reported)September 2008
Actual (reported)Decrease in viral load >= 1.0 log10 at 16 weeks
Positive changes in CD4 count, weight, and Karnofsky Performance Score at 16 weeks
Improvement in quality of life as determined monthly, using the MOS-HIV Health Survey
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
L.A. Gay & Lesbian Center
Los Angeles, California, 90028, United States
University of Miami School of Medicine - AIDS Clinical Research Unit
Miami, Florida, 33136, United States
Northstar Healthcare
Chicago, Illinois, 60657, United States
University of Iowa - HIV/ AIDS Clinical Trials
Iowa City, Iowa, 52242, United States
Beth Israel Medical Center - AIDS Clinical Trials Unit
New York, New York, 10003, United States
University of Texas Southwestern Medical Center - HIV Research Clinic
Dallas, Texas, 75390, United States
Clinical Research Puerto Rico, Inc
Verity EE, Williams LA, Haddad DN, Choy V, O'Loughlin C, Chatfield C, Saksena NK, Cunningham A, Gelder F, McPhee DA. Broad neutralization and complement-mediated lysis of HIV-1 by PEHRG214, a novel caprine anti-HIV-1 polyclonal antibody. AIDS. 2006 Feb 28;20(4):505-15. doi: 10.1097/01.aids.0000210604.78385.95.
Dezube BJ, Proper J, Zhang J, Choy VJ, Weeden W, Morrissey J, Burns EM, Dixon JD, O'Loughlin C, Williams LA, Pickering PJ, Crumpacker CS, Gelder FB. A passive immunotherapy, (PE)HRG214, in patients infected with human immunodeficiency virus: a phase I study. J Infect Dis. 2003 Feb 1;187(3):500-3. doi: 10.1086/367710. Epub 2003 Jan 8.
First Submitted
October 1, 2006
First Posted
October 9, 2006
Study Start
January 2007
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
September 2008
Actual (reported)Contact the study team to confirm eligibility.
San Juan, 00909, Puerto Rico
Pett SL, Williams LA, Day RO, Lloyd AR, Carr AD, Clezy KR, Emery S, Kaplan E, McPhee DA, McLachlan AJ, Gelder FB, Lewin SR, Liauw W, Williams KM. A phase I study of the pharmacokinetics and safety of passive immunotherapy with caprine anti-HIV antibodies, (PE)HRG214, in HIV-1-infected individuals. HIV Clin Trials. 2004 Mar-Apr;5(2):91-8. doi: 10.1310/1FLN-8KFC-5HEQ-K19J.
Study Completion
September 2008
Actual (reported)Last Updated
August 26, 2010
Record last verified: 2010-08
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Source: ClinicalTrials.gov.
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