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An Escalating Dose Tolerance Trial of BG8962 (rCD4) in Patients Who Are HIV Antibody Positive
Not Recruiting
Trial ID: NCT00000721
Purpose
To determine the maximal safe daily dose of BG8962 (rCD4) which can be administered by
continuous subcutaneous infusion (CSCI) over 24 hours; to determine the pharmacokinetics of
BG8962 when it is administered by intramuscular and subcutaneous routes; and to look for dose
related antiviral activity determined by quantitation of infectious HIV peripheral blood
leukocytes (PBLs) and plasma, and by monitoring the blood levels of viral p24 antigen (when
present), CD4+ T-cells, and Beta-2- microglobulin. 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 between these two products, a change in nomenclature has been made. In this
protocol, whenever the original sequence CD4 molecule is referred to, it is called
recombinant soluble T4 (rsT4). Whenever the natural sequence molecule (currently under study
in this protocol) is referred to, it is called BG8962 or rCD4. Whenever the drug is discussed
generically, it is referred to as rsCD4.
Official Title
An Escalating Dose Tolerance Trial of BG8962 (rCD4) in Patients Who Are HIV Antibody Positive
Stanford Investigator(s)
Eligibility
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.
Intervention(s):
drug: CD4 Antigens
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305