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

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00000779
• Other study ID #: ACTG 214
• Secondary ID: 11191
• Status: Completed
• Phase: Phase 1
• Est. completion date: September 1996

Study information

• Verified date: October 2021
• Source: National Institute of Allergy and Infectious Diseases (NIAID)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: September 1996
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• HIV Infections

Intervention

Biological:
• Aluminum hydroxide

• MF59

• rgp120/HIV-1IIIB

• rgp120/HIV-1MN

• rgp120/HIV-1 SF-2

• Env 2-3

Locations

Country	Name	City	State
United States	University of Colorado Hospital CRS	Aurora	Colorado
United States	Beth Israel Deaconess Med. Ctr., ACTG CRS	Boston	Massachusetts
United States	Bmc Actg Crs	Boston	Massachusetts
United States	Massachusetts General Hospital ACTG CRS	Boston	Massachusetts
United States	UCLA CARE Center CRS	Los Angeles	California
United States	NY Univ. HIV/AIDS CRS	New York	New York
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 Washington AIDS CRS	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. Epub 2000 Oct 9. — View Citation