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

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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.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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