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

Genentech

Status and phase: Completed; Phase 1

Conditions: HIV Infections

Treatments: Biological: rgp120/HIV-1IIIB

Study type: Interventional

Funder types: Industry

Identifiers

NCT00001992

V0200g

075A

Details and patient eligibility

About

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

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

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.

Exclusion Criteria

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:

Excluded:

• 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.