A Phase I Study of the Safety and Pharmacokinetics of Recombinant Human CD4 Immunoglobulin (rCd4-IgG) Administered by Intravenous Bolus in Patients With AIDS and AIDS Related Complex

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

Keywords

ClinConnect Summary

Other approaches in addition to existing treatment of HIV infection need to be evaluated. One approach may be to block HIV infection by interrupting the assembly of the virus within the cell or the budding of virus from the membrane of the infected cell. In addition, blocking the attachment of HIV to its cellular receptor may offer another point of attack. HIV binds to the CD4 receptor on the target T4 lymphocyte and the envelope glycoprotein of the virus (gp120) is capable of high affinity binding to CD4. Any agent that prevents the attachment of gp120 to the CD4 receptor should be able to...

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Eligibility criteria

• • Inclusion Criteria
• Patients must fulfill the following criteria:
• • Diagnosis of AIDS or AIDS-related complex, according to CDC criteria, in previously documented HIV seropositive individuals.
• • Failure to tolerate or respond to zidovudine (AZT) therapy for HIV infection or a decision to decline such therapy.
• • Willingness to abstain from all other experimental therapy for HIV infection during study period.
• • Life expectancy of at least 3 months.
• • Patients must be able to sign a written informed consent form.
• • Exclusion Criteria
• Co-existing Condition:
• Patients with the following are excluded:
• • Serious active opportunistic infection or malignancies not specifically allowed.
• Concurrent Medication:
• Excluded:
• • Oral or intravenous acyclovir for herpes.
• • Zidovudine (AZT).
• • Interferon.
• • Corticosteroids.
• • Nonsteroidal anti-inflammatory agents (NSAIDS).
• • Intravenous acyclovir.
• • Other known immunomodulatory agents.
• • Other experimental therapy.
• Patients with the following are excluded:
• • Serious active opportunistic infection or malignancies not specifically allowed.
• Prior Medication:
• Excluded within 4 weeks of study entry:
• • Zidovudine (AZT).
• • Chemotherapy.
• • Immunomodulatory agents.
• • Other experimental therapy.