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A Phase I/II Trial of Vaccine Therapy of HIV-1 Infected Individuals With 50-500 CD4 Cells/mm3

This study has been completed.
Sponsor:
Collaborators:
Genentech, Inc.
Glaxo Wellcome
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00000755
First received: November 2, 1999
Last updated: May 22, 2012
Last verified: May 2012
  Purpose

To examine the response of HIV-1 infected patients to vaccination with gp120/HIV-1MN antigen. To determine the effect of antiretroviral therapy on vaccine responsiveness.

Fifty percent of HIV-1 infected individuals remain symptom free for 8-12 years. It has been hypothesized that HIV-specific immune responses are responsible for the period of relative quiescence of viral replication. Recent studies suggest that these immune functions can be augmented by vaccination with HIV-derived antigens.


Condition Intervention Phase
HIV Infections
Biological: rgp120/HIV-1MN
Drug: Zidovudine
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Parallel Assignment
Primary Purpose: Prevention
Official Title: A Phase I/II Trial of Vaccine Therapy of HIV-1 Infected Individuals With 50-500 CD4 Cells/mm3

Resource links provided by NLM:


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

Estimated Enrollment: 168
Study Completion Date: March 1993
Detailed Description:

Fifty percent of HIV-1 infected individuals remain symptom free for 8-12 years. It has been hypothesized that HIV-specific immune responses are responsible for the period of relative quiescence of viral replication. Recent studies suggest that these immune functions can be augmented by vaccination with HIV-derived antigens.

Patients are randomized to receive rgp120/HIV-1MN vaccine or alum adjuvant placebo by intramuscular injection at weeks 0, 4, 8, 12, 16, and 20, with or without daily oral zidovudine (AZT) or their current stable dose of antiretroviral therapy. After completing the primary vaccination series, patients are permitted to continue into an extension phase, in which they receive a booster vaccination at weeks 28, 36, and 44. Patients will be stratified by CD4 count: 350-500, 200-349, and 50-199 cells/mm3. A fourth group with counts of 350-500 cells/mm3 will serve as a pilot group and receive vaccine only.

  Eligibility

Ages Eligible for Study:   13 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

Required immediately prior to study entry:

  • A minimum of 2 and a maximum of 12 months of AZT therapy at 500-600 mg/day (does not apply to the pilot group patients receiving vaccine only and to patients with CD4 counts of 50-199 cells/mm3).

Concurrent Medication:

Allowed:

  • PCP prophylaxis.
  • Rifabutin and clarithromycin (in patients with CD4 counts of 50-199 cells/mm3 only).
  • Short-term nonsteroidal anti-inflammatory therapy for acute conditions.
  • Short intermittent cycles of acyclovir.

Patients must have:

  • HIV infection, with CD4 count of 50-500 cells/mm3.
  • No active opportunistic infection (patients with CD4 counts of 50-199 cells/mm3 may have a history of an opportunistic infection).
  • Consent of parent, guardian, or person with power of attorney, if less than 18 years of age.
  • B-cell lines established in order to be vaccinated.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

  • Known or suspected allergies to any vaccine components.

Concurrent Medication:

Excluded:

  • Agents with immunosuppressive activity.
  • Antiretroviral therapies other than AZT (except in patients with CD4 counts of 50-199 cells/mm3).
  • Interferon.
  • Parenteral therapies (including SC allergy medications and chemotherapy for Kaposi's sarcoma).
  • Steroids.
  • Hematopoietins.

Prior Medication:

Excluded within 12 weeks prior to study entry:

  • Agents with immunosuppressive activity.
  • Antiretroviral therapies other than AZT (except in patients with CD4 counts of 50-349 cells/mm3).
  • Interferon.
  • Parenteral therapies (including SC allergy medications and chemotherapy for Kaposi's sarcoma).
  • Steroids.
  • Hematopoietins.

Active drug abuse.

  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: NCT00000755

Locations
United States, California
UCLA CARE Center CRS
Los Angeles, California, United States, 90095
Stanford CRS
Palo Alto, California, United States, 943055107
Ucsf Aids Crs
San Francisco, California, United States, 941102859
United States, Colorado
University of Colorado Hospital CRS
Aurora, Colorado, United States, 80262
United States, Massachusetts
Beth Israel Deaconess - East Campus A0102 CRS
Boston, Massachusetts, United States, 02215
Beth Israel Deaconess Med. Ctr., ACTG CRS
Boston, Massachusetts, United States, 02215
Bmc Actg Crs
Boston, Massachusetts, United States, 02118
Massachusetts General Hospital ACTG CRS
Boston, Massachusetts, United States, 02114
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
Genentech, Inc.
Glaxo Wellcome
Investigators
Study Chair: Schooley RT
Study Chair: Walker B
  More Information

Additional Information:
Publications:
Kuritzkes DR, Spino C, Valentine F, Schooley RT. Association of plasma HIV-1 RNA, CD4 count, and immune response in patients with 50-500 CD4 cells/ul. Conf Retroviruses Opportunistic Infect. 1997 Jan 22-26;4th:204 (abstract no 757)
Schooley RT, Spino C, Chiu S, DeGruttola V, Kuritzkes DR. Poor immunogenicity of HIV-1 envelope vaccines with alum or MF59 aduvant in HIV-infected individuals: results of two randomized trials. Conf Retroviruses Opportunistic Infect. 1997 Jan 22-26;4th:204 (abstract no 756)

Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00000755     History of Changes
Other Study ID Numbers: ACTG 209, 11186
Study First Received: November 2, 1999
Last Updated: May 22, 2012
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
RNA Virus Infections
Retroviridae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases
Zidovudine
Anti-HIV Agents
Anti-Infective Agents
Anti-Retroviral Agents
Antimetabolites
Antiviral Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014