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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
This study has been completed.
First Received: November 2, 1999   Last Updated: June 23, 2005   History of Changes
Sponsor: Genentech
Information provided by: NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier: NCT00001992
  Purpose

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


Condition Intervention Phase
HIV Infections
Biological: rgp120/HIV-1IIIB
Phase I

Study Type: Interventional
Study Design: Prevention
Official Title: A Phase I Study of the Safety and Immunogenicity of Rgp 120/HIV-1IIIB Vaccine in HIV-1 Seropositive Adult Volunteers

Resource links provided by NLM:

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00001992

Locations
United States, Maryland
Walter Reed Army Institute of Research
Rockville, Maryland, United States, 20850
Sponsors and Collaborators
Genentech
  More Information

No publications provided

Study ID Numbers: 075A, V0200g
Study First Received: November 2, 1999
Last Updated: June 23, 2005
ClinicalTrials.gov Identifier: NCT00001992     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:
Vaccines, Synthetic
Drug Evaluation
Acquired Immunodeficiency Syndrome
AIDS Vaccines

Additional relevant MeSH terms:
Virus Diseases
Sexually Transmitted Diseases, Viral
RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
HIV Infections
Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Infection
Retroviridae Infections
Immunologic Deficiency Syndromes

ClinicalTrials.gov processed this record on November 09, 2009