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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

To determine the safety profile and maximum tolerated dose (MTD) of recombinant soluble human CD4 (rCD4) therapy in patients with AIDS or AIDS related complex (ARC). To obtain a preliminary indication of the antiviral effects of rCD4 in patients with AIDS and ARC. To measure steady state serum levels of rCD4 following continuous infusion therapy.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Genentech, Inc.

Criteria

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.