Trial record 17 of 30 for:    " May 31, 2009":" June 30, 2009"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]

A Study of Anti-HIV Monoclonal Antibody KD-247

This study has been completed.
Sponsor:
Information provided by:
The Chemo-Sero-Therapeutic Research Institute
ClinicalTrials.gov Identifier:
NCT00917813
First received: June 8, 2009
Last updated: November 16, 2012
Last verified: November 2012
  Purpose

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.


Condition Intervention Phase
HIV Infections
Drug: KD-247
Drug: Physiological saline
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by The Chemo-Sero-Therapeutic Research Institute:

Estimated Enrollment: 27
Study Start Date: September 2007
Arms Assigned Interventions
Experimental: KD-247 Drug: KD-247
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
Placebo Comparator: Placebo Drug: Physiological saline
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

Detailed Description:

A minimum of 6 active subjects and 3 placebo subjects for each dose cohort will complete 2 weeks of infusions. A maximum of 27 total subjects will be dosed with KD-247 and up to 9 total will receive placebo. Per cohort subjects randomized to active treatment will receive iv infusions of KD 247 over 2 hours at each dosing visit. Subjects randomized to placebo will receive 2-hour iv infusions of saline solution at each dosing visit. Following the first infusion of KD-247 (or placebo) for each subject in the study, there will be a 24-hour in-patient observation period before the next subject can be randomized within the study. Dose escalation will proceed only after safety data through Day 18 for all subjects in the lower-dose cohort is reviewed.

  Eligibility

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

Inclusion Criteria:

  1. Have HIV-1 infection confirmed by enzyme immunoassay (EIA) and immunoblot.
  2. Are male or female subjects, age 18-64 years.
  3. 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.
  4. 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.
  5. Are treatment naïve or have been off antiretroviral drugs for at least 8 weeks prior to screening.
  6. 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.
  7. Weigh 45-120 kg.
  8. Have an absolute neutrophil count >1000 cells/uL, hemoglobin (Hgb) >10 g/dL, and platelets >100,000/uL.
  9. Have serum creatinine ≤1.5 mg/dL and alanine transaminase (ALT) <2.5 times the upper limit of normal.
  10. Have a 12-lead electrocardiogram (ECG) without clinically significant abnormalities in the opinion of the investigator.
  11. 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.
  12. 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.
  13. Be willing and able to provide written informed consent.

Exclusion Criteria:

  1. 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).
  2. Have received monoclonal antibody therapy of any kind in the past.
  3. Received vaccinations in the past 15 days prior to study entry.
  4. Received antihistamines in the 6 weeks prior to study entry.
  5. Received non-steroidal anti-inflammatory drugs (NSAIDs) in the 5-6 days prior to skin test.
  6. Any history of anaphylaxis, asthma, hypersensitivity reaction to a vaccine or drug infusion, angioedema, or urticaria.
  7. 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.
  8. Have received any investigational agent within 60 days prior to screening.
  9. 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.
  10. 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.
  11. Have an unexplained positive urine drug screen test for an illicit drug.
  12. Have a confirmed positive hepatitis B surface antigen (HBsAg) or antibody to hepatitis C virus (HCV).
  13. 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.
  14. 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.
  15. Have a recent history of major surgery, internal organ biopsy, or major trauma.
  16. Females who are pregnant or breast-feeding, or who plan to become pregnant during the study.
  17. Have a mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study.
  18. Show a positive reaction to the prick test for KD-247, i.e., ≥3 mm in diameter greater than the negative control.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00917813

Locations
United States, California
Pacific Oaks Medical Group
Beverly Hills, California, United States, 90211
Providence Clinical Research
Burbank, California, United States, 91505
Peter J. Ruane, MD, Inc.
Los Angeles, California, United States, 90036
United States, District of Columbia
Washington Hospital Center CAR
Washington, DC, District of Columbia, United States, 20010
United States, Florida
Gary Richmond, MD, PA
Fort Lauderdale, Florida, United States, 33316
Orlando Immunology Center
Orlando, Florida, United States, 32803-1851
Vita Research Solutions, Inc.
Tamarac, Florida, United States, 33319
United States, Georgia
AIDS Research Consortium of Atlanta
Atlanta, Georgia, United States, 30308
United States, Illinois
Northstar Medical
Chicago, Illinois, United States, 60657
United States, Maryland
Institute of Human Virology, University of Maryland
Baltimore, Maryland, United States, 21201
United States, New York
Albany Medical Center
Albany, New York, United States, 12208
Aaron Diamond AIDS Research Center (ADARC)
New York, New York, United States, 10016
United States, Texas
Central Texas Clinical Research
Austin, Texas, United States, 78705
Therapeutic Concepts, P.A.
Houston, Texas, United States, 77004
DCOL Center for Clinical Research
Longview, Texas, United States, 75605
Sponsors and Collaborators
The Chemo-Sero-Therapeutic Research Institute
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00917813     History of Changes
Other Study ID Numbers: KD-1002
Study First Received: June 8, 2009
Last Updated: November 16, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by The Chemo-Sero-Therapeutic Research Institute:
HIV
monoclonal antibody
KD-247
treatment naive

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Antibodies
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 15, 2014