A Phase I Study of Recombinant CD4(rCD4) in Patients With AIDS and AIDS-Related Complex

Launched by GENENTECH, INC. · Aug 30, 2001

Keywords

ClinConnect Summary

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Gender

ALL

Eligibility criteria

• • Inclusion Criteria
• Patients must have:
• • HIV-1 seropositivity.
• • Diagnosis of AIDS or AIDS related complex (ARC).
• • Failure to tolerate or respond to zidovudine (AZT) or decided to decline AZT therapy.
• • The ability to sign a written informed consent form prior to treatment.
• • A willingness to abstain from all other experimental therapy for HIV infection during the entire study period.
• • A life expectancy of at least 3 months.
• • Exclusion Criteria
• Co-existing Condition:
• Patients with the following conditions or symptoms are excluded:
• • Serious active opportunistic infections.
• • Malignancies other than Kaposi's sarcoma.
• Concurrent Medication:
• Excluded:
• • Zidovudine (AZT).
• • Corticosteroids.
• • Nonsteroidal anti-inflammatory agents (NSAI).
• • Other experimental therapy.
• Patients with the following are excluded:
• • Serious active opportunistic infections.
• • Malignancies other than Kaposi's sarcoma.
• Prior Medication:
• Excluded within 3 weeks of study entry:
• • Zidovudine (AZT).
• • Chemotherapy.
• • Immunomodulators.
• • Other experimental therapy.