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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 |
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 |
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 |
Estimated Enrollment: | 168 |
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.
Ages Eligible for Study: | 13 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Required immediately prior to study entry:
Concurrent Medication:
Allowed:
Patients must have:
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
Concurrent Medication:
Excluded:
Prior Medication:
Excluded within 12 weeks prior to study entry:
Active drug abuse.
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 |
National Institute of Allergy and Infectious Diseases (NIAID) |
Genentech |
Glaxo Wellcome |
Study Chair: | Schooley RT | |
Study Chair: | Walker B |
Click here for more information about Zidovudine 
  |
Study ID Numbers: | ACTG 209 |
First Received: | November 2, 1999 |
Last Updated: | July 29, 2008 |
ClinicalTrials.gov Identifier: | NCT00000755 |
Health Authority: | United States: Federal Government |
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