Status:
COMPLETED
An Escalating Dose Tolerance Trial of BG8962 (rCD4) in Patients Who Are HIV Antibody Positive
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsors:
Biogen
Conditions:
HIV Infections
Eligibility:
All Genders
13+ years
Phase:
PHASE1
Brief Summary
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 adm...
Detailed 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 inhi...
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.
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
March 1 1991
Estimated Enrollment :
85 Patients enrolled
Trial Details
Trial ID
NCT00000721
End Date
March 1 1991
Last Update
October 28 2021
Active Locations (1)
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1
Stanford CRS
Palo Alto, California, United States, 943055107