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

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID) (NIH)

Overall Status

Completed

CT.gov ID

NCT00000779

Collaborator

(none)

130

Enrollment

Locations

Patients Per Site

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
HIV Infections	Biological: Aluminum hydroxide Biological: MF59 Biological: rgp120/HIV-1IIIB Biological: rgp120/HIV-1MN Biological: rgp120/HIV-1 SF-2 Biological: Env 2-3	Phase 1

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 Design

Study Type:

Interventional

Allocation:

Randomized

Primary Purpose:

Prevention

Official Title:

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

Actual Study Completion Date :

Sep 1, 1996

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

13 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UCLA CARE Center CRS	Los Angeles	California	United States
2	Stanford CRS	Palo Alto	California	United States	94115
3	Santa Clara Valley Med. Ctr.	San Jose	California	United States	951282699
4	San Mateo County AIDS Program	San Mateo	California	United States	943055107
5	University of Colorado Hospital CRS	Aurora	Colorado	United States	80262
6	Massachusetts General Hospital ACTG CRS	Boston	Massachusetts	United States	02114
7	Bmc Actg Crs	Boston	Massachusetts	United States	02118
8	Beth Israel Deaconess Med. Ctr., ACTG CRS	Boston	Massachusetts	United States	02215
9	NY Univ. HIV/AIDS CRS	New York	New York	United States	10016
10	University of Washington AIDS CRS	Seattle	Washington	United States	981224304