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
HIV Infections
About this trial
This is an interventional treatment trial for HIV Infections focused on measuring Recombinant Proteins, Injections, Intravenous, IgG, Drug Evaluation, Administration, Oral, Acquired Immunodeficiency Syndrome, Antigens, CD4, Zidovudine, Carrier Proteins
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.
Sites / Locations
- Univ of California / San Diego Treatment Ctr
- Univ of Miami School of Medicine
- Univ of Massachusetts