A Study of Anti-HIV Monoclonal Antibody KD-247
A Study of the Safety, Tolerability, and Pharmacokinetics of KD-247, a Humanized Monoclonal Antibody That Recognizes the Principal Neutralizing Determinant of HIV-1, in Asymptomatic HIV-1 Seropositive Individuals Who Are Not Receiving Concurrent Antiretroviral Therapy
1 other identifier
interventional
27
1 country
15
Brief Summary
The purpose of this study is to evaluate the safety and tolerability of 3 infusions of KD-247 over 2 weeks in HIV-1 seropositive individuals; to determine the pharmacokinetic parameters of KD-247 when administered as above; and to assess the effect of KD-247 infusions on plasma HIV-1 ribonucleic acid (RNA) load and on CD4+ T cell counts.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 hiv-infections
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2007
CompletedFirst Submitted
Initial submission to the registry
June 8, 2009
CompletedFirst Posted
Study publicly available on registry
June 10, 2009
CompletedNovember 19, 2012
November 1, 2012
June 8, 2009
November 16, 2012
Conditions
Keywords
Study Arms (2)
KD-247
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Cohort 1 - 4 mg/kg KD-247 IV on Days 1, 8, and 15; Cohort 2 - 8 mg/kg KD-247 IV on Days 1, 8, and 15; Cohort 3 - 16 mg/kg KD-247 IV on Days 1, 8, and 15
Cohort 1 - Physiological saline IV on Days 1, 8, and 15; Cohort 2 - Physiological saline IV on Days 1, 8, and 15; Cohort 3 - Physiological saline IV on Days 1, 8, and 15
Eligibility Criteria
You may qualify if:
- Have HIV-1 infection confirmed by enzyme immunoassay (EIA) and immunoblot.
- Are male or female subjects, age 18-64 years.
- Demonstrate an HIV-1 RNA copy number between 1000 and 100,000 copies/mL on 2 measurements at least 2 weeks apart. Measurements taken during screening and/or on a prior non-study related medical visit within 3 to 6 weeks of Study Day 1 may be considered.
- Have CD4+ T cell count \>350 cells/mm3 on 2 measurements at least 2 weeks apart. Measurements taken during screening and on one prior non-study medical visit within 3 to 6 weeks of Study Day 1 may be considered.
- Are treatment naïve or have been off antiretroviral drugs for at least 8 weeks prior to screening.
- By genotyping, have a sequence of the portion of the HIV envelope gene encoding the principal neutralizing determinant that is consistent with neutralization by KD-247.
- Weigh 45-120 kg.
- Have an absolute neutrophil count \>1000 cells/uL, hemoglobin (Hgb) \>10 g/dL, and platelets \>100,000/uL.
- Have serum creatinine ≤1.5 mg/dL and alanine transaminase (ALT) \<2.5 times the upper limit of normal.
- Have a 12-lead electrocardiogram (ECG) without clinically significant abnormalities in the opinion of the investigator.
- Female subjects must be:
- Women of non-childbearing potential, defined as either surgically sterile or at least 1-year post-menopausal (no menstrual periods for at least 2 years), or
- Women of childbearing potential using a highly effective method of contraception, and
- Women of childbearing potential with a negative serum beta human chorionic gonadotropin (β-HCG) test result at screening and within the 24 hours prior to administration of study drug. A negative urine pregnancy test within the 24 hours prior to administration of study drug will be acceptable, if the serum pregnancy test result is not yet available.
- For heterosexual male subjects, the subject and the subject's sexual partner must agree to use acceptable methods of contraception during the entire study. Acceptable methods include, but are not limited to, intrauterine device, diaphragm with spermicide, condoms, or abstinence. Oral contraceptives alone are not an acceptable method of birth control.
- +1 more criteria
You may not qualify if:
- Have a history of an acquired immune deficiency syndrome (AIDS)-defining illness or symptomatic HIV disease (i.e., Centers for Disease Control \[CDC\] Class B or C).
- Have received monoclonal antibody therapy of any kind in the past.
- Received vaccinations in the past 15 days prior to study entry.
- Received antihistamines in the 6 weeks prior to study entry.
- Received non-steroidal anti-inflammatory drugs (NSAIDs) in the 5-6 days prior to skin test.
- Any history of anaphylaxis, asthma, hypersensitivity reaction to a vaccine or drug infusion, angioedema, or urticaria.
- Have been treated with any of the following within the 3 months prior to screening: interferons, cytokines, or other immunomodulators; immunoglobulin therapy; systemic corticosteroids; cytotoxic drugs; or ionizing radiation.
- Have received any investigational agent within 60 days prior to screening.
- Have any condition which, in the judgment of the investigator, may make the subject's participation in this study too risky; interfere with the collection of or interpretation of PK data; or interfere with the ability of the subject to adhere to and complete the study. Such conditions may include, but are not limited to, cardiovascular, respiratory, gastrointestinal/hepatic, neurologic, and genitourinary disorders.
- Current alcohol or drug use that, in the judgment of the investigator, will interfere with the subject's ability to comply with the protocol requirements.
- Have an unexplained positive urine drug screen test for an illicit drug.
- Have a confirmed positive hepatitis B surface antigen (HBsAg) or antibody to hepatitis C virus (HCV).
- Have used any prescription within 14 days of study initiation or any over-the-counter (OTC) medication within 3 days of study initiation which, in the judgment of the investigator, would place the individual at risk or interfere with safety, tolerability, or PK data.
- Have dosages/amounts of drugs that have changed, or are scheduled to use new drugs which, in the judgment of the investigator, would place the individual at risk or interfere with safety, tolerability, or PK data.
- Have a recent history of major surgery, internal organ biopsy, or major trauma.
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (15)
Pacific Oaks Medical Group
Beverly Hills, California, 90211, United States
Providence Clinical Research
Burbank, California, 91505, United States
Peter J. Ruane, MD, Inc.
Los Angeles, California, 90036, United States
Washington Hospital Center CAR
Washington D.C., District of Columbia, 20010, United States
Gary Richmond, MD, PA
Fort Lauderdale, Florida, 33316, United States
Orlando Immunology Center
Orlando, Florida, 32803-1851, United States
Vita Research Solutions, Inc.
Tamarac, Florida, 33319, United States
AIDS Research Consortium of Atlanta
Atlanta, Georgia, 30308, United States
Northstar Medical
Chicago, Illinois, 60657, United States
Institute of Human Virology, University of Maryland
Baltimore, Maryland, 21201, United States
Albany Medical Center
Albany, New York, 12208, United States
Aaron Diamond AIDS Research Center (ADARC)
New York, New York, 10016, United States
Central Texas Clinical Research
Austin, Texas, 78705, United States
Therapeutic Concepts, P.A.
Houston, Texas, 77004, United States
DCOL Center for Clinical Research
Longview, Texas, 75605, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
June 8, 2009
First Posted
June 10, 2009
Study Start
September 1, 2007
Last Updated
November 19, 2012
Record last verified: 2012-11