A Phase I Study of the Safety and Immunogenicity of Rgp 120/HIV-1IIIB Vaccine in HIV-1 Seropositive Adult Volunteers

Genentech, Inc.1 site in 1 countryStarted: August 31, 2001Last updated: June 24, 2005

Conditions

Trial Snapshot

To test the safety and immunogenicity of rgp 120/HIV-1IIIB vaccine in HIV-1 seropositive adult patients.

•Patients must have the following:
•Stage 1 or 2 Walter Reed clinical staging of HIV infected individuals.
•The ability to understand and sign a written informed consent form, which must be obtained prior to study entry.
•Be available for 24 weeks so that follow up may be completed.
•Qualify for care as Department of Defense health care beneficiary.

•Co-existing Condition:
•Patients with the following conditions or symptoms are excluded:
•Prior history of clinically significant cardiac, pulmonary, hepatic, renal, neurologic or autoimmune disease, other than HIV-1 infection, and in less than average general health as determined by a medical history, physical examination, and the required laboratory test results.
•Concurrent Medication:
•Corticosteroids or other known immunosuppressive drugs.
•Any experimental agents.
•Patients with the following are excluded:
•Prior history of clinically significant cardiac, pulmonary, hepatic, renal, neurologic or autoimmune disease, other than HIV-1 infection, and in less than average general health as determined by a medical history, physical examination, and the required laboratory test results.
•Prior Medication:
•Excluded within 30 days of study entry:
•Zidovudine or other anti-retroviral agents.

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