A Phase I/II Trial of Vaccine Therapy of HIV-1 Infected Individuals With 50-500 CD4 Cells/mm3
2 other identifiers
interventional
168
1 country
10
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 hiv-infections
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Completion
Last participant's last visit for all outcomes
March 1, 1993
CompletedFirst Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedNovember 4, 2021
October 1, 2021
November 2, 1999
October 27, 2021
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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).
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)lead
- Genentech, Inc.collaborator
- Glaxo Wellcomecollaborator
Study Sites (10)
UCLA CARE Center CRS
Los Angeles, California, 90095, United States
Stanford CRS
Palo Alto, California, 943055107, United States
Ucsf Aids Crs
San Francisco, California, 941102859, United States
University of Colorado Hospital CRS
Aurora, Colorado, 80262, United States
Massachusetts General Hospital ACTG CRS
Boston, Massachusetts, 02114, United States
Bmc Actg Crs
Boston, Massachusetts, 02118, United States
Beth Israel Deaconess - East Campus A0102 CRS
Boston, Massachusetts, 02215, United States
Beth Israel Deaconess Med. Ctr., ACTG CRS
Boston, Massachusetts, 02215, United States
NY Univ. HIV/AIDS CRS
New York, New York, 10016, United States
University of Washington AIDS CRS
Seattle, Washington, 981224304, United States
Related Publications (3)
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)
BACKGROUNDSchooley 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)
BACKGROUNDSchooley 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. doi: 10.1086/315860. Epub 2000 Oct 9.
PMID: 11023459BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Schooley RT
- STUDY CHAIR
Walker B
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 2, 1999
First Posted
August 31, 2001
Study Completion
March 1, 1993
Last Updated
November 4, 2021
Record last verified: 2021-10