A Phase I Comparative Blinded Trial of Several HIV-1 Derived Immunogens in Infected Individuals With >= 500 CD4 Cells/mm3
NCT ID: NCT00000779
Last Updated: 2021-11-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
130 participants
INTERVENTIONAL
1996-09-30
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PREVENTION
Interventions
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Aluminum hydroxide
MF59
rgp120/HIV-1IIIB
rgp120/HIV-1MN
rgp120/HIV-1 SF-2
Env 2-3
Eligibility Criteria
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Inclusion Criteria
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
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.
13 Years
ALL
No
Sponsors
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National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Responsible Party
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Principal Investigators
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Schooley RT
Role: STUDY_CHAIR
Walker B
Role: STUDY_CHAIR
Locations
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UCLA CARE Center CRS
Los Angeles, California, United States
Stanford CRS
Palo Alto, California, United States
Santa Clara Valley Med. Ctr.
San Jose, California, United States
San Mateo County AIDS Program
San Mateo, California, United States
University of Colorado Hospital CRS
Aurora, Colorado, United States
Massachusetts General Hospital ACTG CRS
Boston, Massachusetts, United States
Bmc Actg Crs
Boston, Massachusetts, United States
Beth Israel Deaconess Med. Ctr., ACTG CRS
Boston, Massachusetts, United States
NY Univ. HIV/AIDS CRS
New York, New York, United States
University of Washington AIDS CRS
Seattle, Washington, United States
Countries
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References
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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. doi: 10.1086/315860. Epub 2000 Oct 9.
Other Identifiers
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11191
Identifier Type: REGISTRY
Identifier Source: secondary_id
ACTG 214
Identifier Type: -
Identifier Source: org_study_id