A Phase I Study of the Safety and Pharmacokinetics of Recombinant Human CD4-Immunoglobulin G (rCD4-IgG) Administered by Intravenous Bolus Injection in Combination With Oral Zidovudine 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 of recombinant human CD4-immunoglobulin G (CD4-IgG) and zidovudine (AZT) combination therapy in patients with AIDS or AIDS-related complex (ARC); to assess pharmacokinetic (blood level) properties of CD4-IgG in combination with AZT; and to obtain preliminary indication of the antiviral and immunologic effects of CD4-IgG in combination with AZT in patients with AIDS and ARC.

Treatment of AIDS has been directed toward the underlying retroviral infection as well as toward specific opportunistic infections and malignancies that are associated with the syndrome. The most extensively studied drugs are reverse transcriptase inhibitors such as AZT and other nucleoside analogs, including didanosine (ddI) and dideoxycytidine (ddC). The most extensive clinical experience has been achieved with AZT. These clinical trials indicated a decreased incidence of opportunistic infection and increased survival in patients with AIDS. However, AZT treatment is associated with dose-limiting toxicities. Additionally, identification of resistance to AZT has increased the need to test the effectiveness of AZT in combination with other drugs. CD4-IgG is capable of binding to HIV envelope protein (gp120) and inhibiting HIV infectivity in test tube studies. Potential therapeutic benefit in patients with HIV infection may be derived from CD4-IgG.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Collaborator: Genentech, Inc.
• Treatments: Antibodies; CD4 Immunoadhesins; Immunoglobulin G; Immunoglobulins; Zidovudine

Criteria

Inclusion Criteria

Concurrent Medication:

Allowed:

• Topical acyclovir.

Patients must have the following:

• HIV seropositivity.

• Life expectancy of at least 3 months.

• No white or red blood cell casts in urine.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions or symptoms are excluded:

• Serious active opportunistic infection or malignancies other than Kaposi's sarcoma.

• Kaposi's sarcoma requiring therapy, tumor-associated edema, or visceral disease.

Concurrent Medication:

Excluded:

• Intravenous acyclovir for Herpes.

• Interferon.

• Systemic corticosteroids.

• Nonsteroidal anti-inflammatory agents.

• Intravenous acyclovir.

• Other known immunomodulatory agents.

• Dideoxycytosine (ddC), didanosine (ddI).

• Other nucleoside analogs not specifically allowed.

• Other experimental therapy.

Patients with the following are excluded:

• Serious active opportunistic infection or malignancies other than Kaposi's sarcoma.

• More than 120 days (total) of prior zidovudine (AZT) therapy.

• Currently receiving intravenous acyclovir for Herpes.

Prior Medication:

Excluded:

• > 120 days total of prior zidovudine (AZT) therapy.

• Excluded within 3 weeks of study entry:

• Immunomodulatory agents.

• Other experimental therapy.

Prior Treatment:

Excluded within the past 3 months:

• Transfusion.