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

Completed · Phase 1

Conditions studied: HIV Infections

In brief

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.

Key facts

Study ID

NCT00000976

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

40

Last updated by the study team

2008-08-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Univ of California / San Diego Treatment Ctr — San Diego, California, United States
• Univ of Miami School of Medicine — Miami, Florida, United States
• Univ of Massachusetts — Worcester, Massachusetts, United States

Full record on ClinicalTrials.gov

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