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

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001

Keywords

ClinConnect Summary

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-l...

Gender

ALL

Eligibility 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.

Trial Officials