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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Page 1 of 1 (1 locations)

1

Stanford CRS

Palo Alto, California, United States, 943055107