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A Phase I Comparative Blinded Trial of Several HIV-1 Derived Immunogens in Infected Individuals With >= 500 CD4 Cells/mm3

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Aluminum hydroxide
MF59
rgp120/HIV-1IIIB
rgp120/HIV-1MN
rgp120/HIV-1 SF-2
Env 2-3
Sponsored by
National Institute of Allergy and Infectious Diseases (NIAID)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV Infections focused on measuring Vaccines, Synthetic, HIV-1, Adjuvants, Immunologic, AIDS-Related Complex, HIV Envelope Protein gp120, AIDS Vaccines, HIV Therapeutic Vaccine

Eligibility Criteria

13 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria Concurrent Medication: 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 Co-existing Condition: 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.

Sites / Locations

  • UCLA CARE Center CRS
  • Stanford CRS
  • Santa Clara Valley Med. Ctr.
  • San Mateo County AIDS Program
  • University of Colorado Hospital CRS
  • Massachusetts General Hospital ACTG CRS
  • Bmc Actg Crs
  • Beth Israel Deaconess Med. Ctr., ACTG CRS
  • NY Univ. HIV/AIDS CRS
  • University of Washington AIDS CRS

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
October 27, 2021
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
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1. Study Identification

Unique Protocol Identification Number
NCT00000779
Brief Title
A Phase I Comparative Blinded Trial of Several HIV-1 Derived Immunogens in Infected Individuals With >= 500 CD4 Cells/mm3
Official Title
A Phase I Comparative Blinded Trial of Several HIV-1 Derived Immunogens in Infected Individuals With >= 500 CD4 Cells/mm3
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 1996 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)

4. Oversight

5. Study Description

Brief Summary
PRIMARY: To compare the immunogenicity and safety of each of several HIV-1 derived immunogens versus control in HIV-infected individuals with CD4 counts greater than or equal to 500 cells/mm3. 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
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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Vaccines, Synthetic, HIV-1, Adjuvants, Immunologic, AIDS-Related Complex, HIV Envelope Protein gp120, AIDS Vaccines, HIV Therapeutic Vaccine

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Allocation
Randomized
Enrollment
130 (false)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
Aluminum hydroxide
Intervention Type
Biological
Intervention Name(s)
MF59
Intervention Type
Biological
Intervention Name(s)
rgp120/HIV-1IIIB
Intervention Type
Biological
Intervention Name(s)
rgp120/HIV-1MN
Intervention Type
Biological
Intervention Name(s)
rgp120/HIV-1 SF-2
Intervention Type
Biological
Intervention Name(s)
Env 2-3

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria Concurrent Medication: 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 Co-existing Condition: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Schooley RT
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Walker B
Official's Role
Study Chair
Facility Information:
Facility Name
UCLA CARE Center CRS
City
Los Angeles
State/Province
California
Country
United States
Facility Name
Stanford CRS
City
Palo Alto
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
Santa Clara Valley Med. Ctr.
City
San Jose
State/Province
California
ZIP/Postal Code
951282699
Country
United States
Facility Name
San Mateo County AIDS Program
City
San Mateo
State/Province
California
ZIP/Postal Code
943055107
Country
United States
Facility Name
University of Colorado Hospital CRS
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80262
Country
United States
Facility Name
Massachusetts General Hospital ACTG CRS
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Bmc Actg Crs
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Name
Beth Israel Deaconess Med. Ctr., ACTG CRS
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
NY Univ. HIV/AIDS CRS
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
University of Washington AIDS CRS
City
Seattle
State/Province
Washington
ZIP/Postal Code
981224304
Country
United States

12. IPD Sharing Statement

Citations:
Citation
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)
Results Reference
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PubMed Identifier
11023459
Citation
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.
Results Reference
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A Phase I Comparative Blinded Trial of Several HIV-1 Derived Immunogens in Infected Individuals With >= 500 CD4 Cells/mm3

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