A Phase I Study of the Safety and Pharmacokinetics of Recombinant CD4 (rCD4) in Patients With AIDS and AIDS-Related Complex

Inclusion Criteria

Patients must have:

• HIV-1 seropositivity.
• Diagnosis of AIDS or AIDS related complex (ARC).
• Failure to tolerate or respond to zidovudine (AZT) or decided to decline AZT therapy.
• The ability to sign a written informed consent form prior to treatment.
• A willingness to abstain from all other experimental therapy for HIV infection during the entire study period.
• A life expectancy of at least 3 months.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions or symptoms are excluded:

• Serious active opportunistic infections.
• Malignancies other than Kaposi's sarcoma.

Concurrent Medication:

Excluded:

• Zidovudine (AZT).
• Corticosteroids.
• Nonsteroidal anti-inflammatory agents (NSAI).
• Other experimental therapy.

Patients with the following are excluded:

• Serious active opportunistic infections.
• Malignancies other than Kaposi's sarcoma.

Prior Medication:

Excluded within 3 weeks of study entry:

• Zidovudine (AZT).
• Chemotherapy.
• Immunomodulators.
• Other experimental therapy.