Completed

Phase 1
Age: 13Years +
All Genders
ID00000779

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

Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2021-11-04

130

Participants Needed

10

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

PRIMARY: To compare the immunogenicity and safety of each of several HIV-1 derived immunogens versus control in HIV-infected individuals with CD4 counts greater than or equal to 500 cells/mm3. SECONDARY: To determine whether significant advantages to any one vaccine exist. 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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 13Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

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.
Not Eligible

You will not qualify if you...

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety

Trial Site Locations

Total: 10 locations

1

UCLA CARE Center CRS

Los Angeles, California, United States

Status Unknown

2

Stanford CRS

Palo Alto, California, United States, 94115

Status Unknown

3

Santa Clara Valley Med. Ctr.

San Jose, California, United States, 951282699

Status Unknown

4

San Mateo County AIDS Program

San Mateo, California, United States, 943055107

Status Unknown

5

University of Colorado Hospital CRS

Aurora, Colorado, United States, 80262

Status Unknown

6

Massachusetts General Hospital ACTG CRS

Boston, Massachusetts, United States, 02114

Status Unknown

7

Bmc Actg Crs

Boston, Massachusetts, United States, 02118

Status Unknown

8

Beth Israel Deaconess Med. Ctr., ACTG CRS

Boston, Massachusetts, United States, 02215

Status Unknown

9

NY Univ. HIV/AIDS CRS

New York, New York, United States, 10016

Status Unknown

10

University of Washington AIDS CRS

Seattle, Washington, United States, 981224304

Status Unknown

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

N/A

Allocation

RANDOMIZED

Model

N/A

Primary Purpose

PREVENTION

Number of Arms

0

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Published Research Related To This Trial

Two double-blinded, randomized, comparative trials of 4 human immunodeficiency virus type 1 (HIV-1) envelope vaccines in HIV-1-infected individuals across a spectrum of disease severity: AIDS Clinical Trials Groups 209 and 214.

R T Schooley, C Spino, D Kuritzkes...

https://pubmed.ncbi.nlm.nih.gov/11023459