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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.
Sponsors and Collaborators: National Institute of Allergy and Infectious Diseases (NIAID)
Genentech
Glaxo Wellcome
Information provided by: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00000755
  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 I

MedlinePlus related topics: AIDS
Drug Information available for: Zidovudine
U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Parallel Assignment
Official Title: A Phase I/II Trial of Vaccine Therapy of HIV-1 Infected Individuals With 50-500 CD4 Cells/mm3

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

Estimated Enrollment: 168
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00000755

Locations
United States, California
San Francisco Gen Hosp
San Francisco, California, United States, 941102859
San Francisco AIDS Clinic / San Francisco Gen Hosp
San Francisco, California, United States, 941102859
Stanford Univ Med Ctr
Stanford, California, United States, 943055107
UCLA CARE Ctr
Los Angeles, California, United States, 90095
AIDS Clinical Research Ctr / UCLA Med Ctr
Los Angeles, California, United States, 900951793
United States, Colorado
Univ of Colorado Health Sciences Ctr
Denver, Colorado, United States, 80262
United States, Connecticut
Yale Univ / New Haven
New Haven, Connecticut, United States, 065102483
Yale Univ
New Haven, Connecticut, United States, 06519
United States, Massachusetts
Harvard (Massachusetts Gen Hosp)
Boston, Massachusetts, United States, 02114
Beth Israel Deaconess Med Ctr
Boston, Massachusetts, United States, 02215
Beth Israel Deaconess - West Campus
Boston, Massachusetts, United States, 02215
Boston Med Ctr
Boston, Massachusetts, United States, 02118
United States, New York
Bellevue Hosp / New York Univ Med Ctr
New York, New York, United States, 10016
United States, Washington
Univ of Washington
Seattle, Washington, United States, 981224304
Sponsors and Collaborators
Genentech
Glaxo Wellcome
Investigators
Study Chair: Schooley RT
Study Chair: Walker B
  More Information

Click here for more information about Zidovudine  This link exits the ClinicalTrials.gov site

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)
Schooley RT, Spino C, Kuritzkes D, Walker BD, Valentine FA, Hirsch MS, Cooney E, Friedland G, Kundu S, Merigan TC Jr, McElrath MJ, Collier A, Plaeger S, Mitsuyasu R, Kahn J, Haslett P, Uherova P, deGruttola V, Chiu S, Zhang B, Jones G, Bell D, Ketter N, Twadell T, Chernoff D, Rosandich M. 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. J Infect Dis. 2000 Nov;182(5):1357-64.

Study ID Numbers: ACTG 209
Study First Received: November 2, 1999
Last Updated: July 29, 2008
ClinicalTrials.gov Identifier: NCT00000755  
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

Study placed in the following topic categories:
Virus Diseases
Sexually Transmitted Diseases, Viral
HIV Infections
Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Zidovudine
AIDS-Related Complex
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:
Antimetabolites
Anti-Infective Agents
RNA Virus Infections
Anti-HIV Agents
Slow Virus Diseases
Immune System Diseases
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Infection
Antiviral Agents
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Anti-Retroviral Agents
Therapeutic Uses
Lentivirus Infections
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on January 15, 2009