Search / Trial NCT00000779

A Phase I Comparative Blinded Trial of Several HIV-1 Derived Immunogens in Infected Individuals With >= 500 CD4 Cells/mm3

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

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Trial Information

Current as of July 14, 2024

Completed

Keywords

Vaccines, Synthetic Hiv 1 Adjuvants, Immunologic Aids Related Complex Hiv Envelope Protein Gp120 Aids Vaccines Hiv Therapeutic Vaccine

Description

Before large clinical trials of anti-HIV vaccines are undertaken, it is important to determine whether there are significant advantages to any one of the vaccines currently offered for such studies. Patients are randomized to receive one of four vaccines or one of two placebo controls. The vaccines are: rgp 120/HIV-1IIIB, rgp 120/HIV-1MN, rgp 120/HIV-1SF, and env 2-3. The two control immunogens are aluminum hydroxide (alum) and BIOCINE Placebo Vaccine 2 (MF-59 adjuvant emulsion in citrate buffer). Patients are vaccinated at weeks 0, 4, 8, 12, 16, 20, 28, and 36. If significant benefit is s...

Gender

All

Eligibility criteria

  • Inclusion Criteria
  • Concurrent Medication:
  • Allowed:
  • Short-term nonsteroidal anti-inflammatory therapy.
  • Patients must have:
  • HIV seropositivity.
  • CD4 count >= 500 cells/mm3.
  • Successful establishment of EBV-transformed B-cell lines at study entry.
  • Consent of parent or guardian if < 18 years of age.
  • Exclusion Criteria
  • Co-existing Condition:
  • Patients with the following symptoms or conditions are excluded:
  • Suspected or known allergies to any vaccine components.
  • Medical contraindication.
  • Problem with compliance.
  • Concurrent Medication:
  • Excluded:
  • Antiretroviral therapy (e.g., AZT, ddI, or ddC).
  • Agents with putative immunomodulating activity (e.g., interferon, steroids, hematopoietin).
  • Parenteral therapies (including SC allergy sensitization).
  • Other investigational HIV drugs or therapies.
  • Prior Medication:
  • Excluded:
  • Any prior vaccinations against HIV.
  • Antiretroviral therapy (e.g., AZT, ddI, or ddC) within the past 6 months.
  • Agents with putative immunomodulating activity (e.g., interferon, steroids, hematopoietin) within the past 3 months.
  • Parenteral therapies (including SC allergy sensitization) within the past 3 months.
  • Other investigational HIV drugs or therapies within the past 3 months.

Attachments

readout_NCT00000779_2024-07-14.pdf

4.5 MB

NCT00000779_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

Los Angeles, California, United States

Palo Alto, California, United States

San Jose, California, United States

San Mateo, California, United States

Aurora, Colorado, United States

Boston, Massachusetts, United States

Boston, Massachusetts, United States

Boston, Massachusetts, United States

New York, New York, United States

Seattle, Washington, 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

5 stars
41
4 stars
6
3 stars
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2 stars
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1 stars
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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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