Search / Trial NCT00000721

An Escalating Dose Tolerance Trial of BG8962 (rCD4) in Patients Who Are HIV Antibody Positive

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001

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Trial Information

Current as of June 14, 2024

Completed

Keywords

Recombinant Proteins Infusions, Intravenous Injections, Intramuscular Injections, Intravenous Injections, Subcutaneous Dose Response Relationship, Drug Drug Evaluation Acquired Immunodeficiency Syndrome Antigens, Cd4 Aids Related Complex

Description

Recombinant soluble CD4 protein (rCD4) is a drug that has been produced by genetic engineering techniques. In laboratory studies, rCD4 binds to HIV and reduces its ability to enter the cell, thus inhibiting its reproduction. Before rCD4 can be tested for therapeutic effectiveness in HIV-infected patients, it is necessary to determine the maximum dose that can be tolerated by humans. AMENDED: To date, Biogen's original sequence recombinant soluble CD4 and Biogen's natural sequence recombinant soluble CD4 have both been referred to as recombinant soluble CD4 (rsCD4). In order to distinguish b...

Gender

All

Eligibility criteria

  • Inclusion Criteria
  • Concurrent Medication:
  • Allowed:
  • Nystatin or clotrimazole for suppression of oral thrush.
  • Aerosolized pentamidine for Pneumocystis prophylaxis in Group A patients.
  • Trimethoprim / sulfamethoxazole for Pneumocystis prophylaxis in patients who are hematologically stable on trimethoprim / sulfamethoxazole.
  • Patients must have:
  • Group A: AIDS and symptoms defined in disease status.
  • Group B: AIDS related complex (ARC) and symptoms defined in disease status.
  • Exclusion Criteria
  • Co-existing Condition:
  • Patients with the following disease or conditions are excluded:
  • Malignancies other than Kaposi's sarcoma.
  • AIDS dementia.
  • Opportunistic infections requiring ongoing therapy except oral thrush suppression with nystatin or clotrimazole or Pneumocystis prophylaxis in Group A patients.
  • Significant organ system dysfunction including:
  • Granulocytopenia with a granulocyte count < 1000 cells/mm3.
  • Thrombocytopenia - < 75000 platelets/mm3.
  • Anemia with a hemoglobin < 9.5 g/dl.
  • Renal dysfunction - creatinine > 2 mg/dl.
  • Hepatic dysfunction with enzymes or bilirubin > 3 x upper limit of normal.
  • Patients with the following are excluded:
  • Preexisting antibodies to rCD4.
  • Malignancies other than Kaposi's sarcoma.
  • AIDS-dementia complex.
  • Opportunistic infections requiring ongoing therapy.
  • Significant organ system dysfunction.
  • Inability to sign voluntarily the consent form.
  • Prior Medication:
  • Excluded:
  • Recombinant soluble CD4 protein (rCD4).
  • Excluded within 30 days of study entry:
  • Immunomodulatory therapy or agent with anti-HIV activity.
  • Chemotherapy.
  • Prior Treatment:
  • Excluded within 30 days of study entry:
  • Radiotherapy.
  • Active illicit drug use or alcohol abuse at time of entry.

Attachments

readout_NCT00000721_2024-06-14.pdf

4.5 MB

NCT00000721_study_protocol.pdf

4.5 MB

About company

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

Jennifer Cobb

Immunology at National Institute of Allergy and Infectious Diseases (NIAID)

Locations

Palo Alto, California, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Reviews (48)

4.6

All reviews come from applied patients

5 stars
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6
3 stars
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1 stars
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Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Michael Foster
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Dries Vincent
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

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