Search / Trial NCT00000633

A Phase I Multicenter Clinical Trial to Evaluate the Safety and Immunogenicity of Immuno-AG Recombinant HIV gp160 in Asymptomatic HIV Seropositive Individuals

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001

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Trial Information

Current as of December 10, 2023

Completed

Keywords

Vaccines, Synthetic Vaccinia Virus Viral Vaccines Hiv 1 Hiv Envelope Protein Gp160 Acquired Immunodeficiency Syndrome Aids Related Complex Aids Vaccines Hiv Therapeutic Vaccine

Description

Potentiation of a patient's immune response to HIV might possibly prolong the period of clinical latency and protect the patient indefinitely. Preliminary results from a study of Immuno-AG recombinant gp160 vaccine in healthy volunteers not infected with HIV suggest that the vaccine is safe and produces antibodies against the virus. Because another previous study failed to demonstrate a specific anti-HIV response in patients injected with a recombinant vaccinia virus containing HIV-1 genes, this study is also testing the immunotherapeutic role of other immunizations (such as hepatitis B vac...

Gender

All

Eligibility criteria

  • Inclusion Criteria
  • Concurrent Medication: Recommended:
  • Prophylaxis with isoniazid in patients not previously treated.
  • Patients must have:
  • HIV seropositivity by Western blot.
  • Normal history and physical exam (generalized lymphadenopathy is acceptable).
  • Mean CD4 cell count = or > 600 cells/mm3 for all visits (minimum 2 counts) within 60 days prior to study entry, with no single count < 450 cells/mm3.
  • Negative PPD test or normal chest x-ray with positive PPD (induration = or > 5 mm).
  • Exclusion Criteria
  • Co-existing Condition:
  • Patients with the following symptoms or conditions are excluded:
  • Hepatitis B surface antigen positive.
  • Evidence of an AIDS- or ARC-defining opportunistic infection.
  • Evidence of disseminated tuberculosis, severe or persistent candidiasis, oral hairy leukoplakia, prolonged or very severe diarrhea, herpes zoster, or herpes simplex persisting more than one month.
  • Active syphilis.
  • Patients with the following prior conditions are excluded:
  • Evidence of psychiatric disorder within the past year that would impair adherence to the protocol.
  • History of an AIDS- or ARC-defining opportunistic infection.
  • History of disseminated tuberculosis, severe or persistent candidiasis, oral hairy leukoplakia, prolonged or very severe diarrhea, herpes zoster, or herpes simplex persisting more than one month.
  • Prior Medication:
  • Excluded:
  • Immunomodulating agents (e.g., isoprinosine, imuthiol, lithium) within 90 days of screening.
  • Immunosuppressive medications within the previous 3 months.
  • Zidovudine (AZT) or any antiviral agent (including interferon) within the previous 6 months.
  • Vaccination against other pathogens within 4 weeks of initial screening laboratory work.
  • Use of illicit drugs or significant amounts of alcohol that could significantly interfere with study compliance.

Attachments

readout_NCT00000633_2023-12-10.pdf

4.5 MB

NCT00000633_study_protocol.pdf

4.5 MB

About company

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

Jennifer Cobb

Immunology at National Institute of Allergy and Infectious Diseases (NIAID)

Locations

Baltimore, Maryland, United States

Saint Louis, Missouri, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Reviews (48)

4.6

All reviews come from applied patients

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Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Michael Foster
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Dries Vincent
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

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