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

This study has been completed.
Study NCT00000779.   Last updated on June 23, 2005.   Information provided by National Institute of Allergy and Infectious Diseases (NIAID)

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Descriptive Information Fields
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
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.

Study Phase Phase I
Study Type  Interventional
Study Design  Prevention, Randomized, Safety Study
Primary Outcome Measure 
Secondary Outcome Measure 
Condition  HIV Infections
Intervention  Biological: Aluminum hydroxide
Biological: MF59
Biological: rgp120/HIV-1IIIB
Biological: rgp120/HIV-1MN
Biological: rgp120/HIV-1 SF-2
Biological: Env 2-3
MEDLINE PMIDs 11023459
Links
Recruitment Information Fields
Recruitment Status  Completed
Enrollment  130
Start Date 
Completion Date
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.
Gender Both
Ages 13 Years and older
Accepts Healthy Volunteers No
Contacts ††
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00000779
Organization ID ACTG 214
Secondary IDs ††
Study Sponsor  National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators ††
Investigators 
Study Chair:     Schooley RT        
Study Chair:     Walker B        
Information Provided By National Institute of Allergy and Infectious Diseases (NIAID)
Verification Date October 2002
First Received Date  November 2, 1999
Last Updated Date June 23, 2005

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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