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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00000779
First received: November 2, 1999
Last updated: May 23, 2012
Last verified: May 2012
  Purpose

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.


Condition Intervention Phase
HIV Infections
Biological: Aluminum hydroxide
Biological: MF59
Biological: rgp120/HIV-1IIIB
Biological: rgp120/HIV-1MN
Biological: rgp120/HIV-1 SF-2
Biological: Env 2-3
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Primary Purpose: Prevention
Official Title: A Phase I Comparative Blinded Trial of Several HIV-1 Derived Immunogens in Infected Individuals With >= 500 CD4 Cells/mm3

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Estimated Enrollment: 130
Study Completion Date: September 1996
Detailed 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 seen among vaccine patients, then placebo patients may receive vaccination with one of the immunogens producing an immune response.

  Eligibility

Ages Eligible for Study:   13 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00000779

Locations
United States, California
UCLA CARE Center CRS
Los Angeles, California, United States
Stanford CRS
Palo Alto, California, United States, 94115
Santa Clara Valley Med. Ctr.
San Jose, California, United States, 951282699
San Mateo County AIDS Program
San Mateo, California, United States, 943055107
United States, Colorado
University of Colorado Hospital CRS
Aurora, Colorado, United States, 80262
United States, Massachusetts
Massachusetts General Hospital ACTG CRS
Boston, Massachusetts, United States, 02114
Beth Israel Deaconess Med. Ctr., ACTG CRS
Boston, Massachusetts, United States, 02215
Bmc Actg Crs
Boston, Massachusetts, United States, 02118
United States, New York
NY Univ. HIV/AIDS CRS
New York, New York, United States, 10016
United States, Washington
University of Washington AIDS CRS
Seattle, Washington, United States, 981224304
Sponsors and Collaborators
Investigators
Study Chair: Schooley RT
Study Chair: Walker B
  More Information

Publications:
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00000779     History of Changes
Other Study ID Numbers: ACTG 214, 11191
Study First Received: November 2, 1999
Last Updated: May 23, 2012
Health Authority: United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Vaccines, Synthetic
HIV-1
Adjuvants, Immunologic
AIDS-Related Complex
HIV Envelope Protein gp120
AIDS Vaccines
HIV Therapeutic Vaccine

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Adjuvants, Immunologic
Aluminum Hydroxide
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antacids
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 28, 2014