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

Genentech

Status and phase: Completed; Phase 1

Conditions: HIV Infections

Treatments: Drug: CD4 Antigens

Study type: Interventional

Funder types: Industry

Identifiers

NCT00002004

Serial Number 002

064A

CO030g

Details and patient eligibility

About

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 assess pharmacokinetic properties of rCD4 in humans. To obtain a preliminary indication of the antiviral effects of rCD4 in patients with AIDS and AIDS related complex (ARC).

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.