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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.

Sponsored by: 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

MedlinePlus related topics:   AIDS   

U.S. FDA Resources

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
  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


Study ID Numbers:   075A, V0200g
First Received:   November 2, 1999
Last Updated:   June 23, 2005
ClinicalTrials.gov Identifier:   NCT00001992
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  

Study placed in the following topic categories:
Virus Diseases
Sexually Transmitted Diseases, Viral
HIV Infections
Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:
RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
Lentivirus Infections
Infection

ClinicalTrials.gov processed this record on November 30, 2008




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