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

National Institute of Allergy and Infectious Diseases (NIAID)

Status and phase: Completed; Phase 1

Conditions: HIV Infections

Treatments: Biological: Env 2-3; Biological: Aluminum hydroxide; Biological: rgp120/HIV-1IIIB; Biological: MF59; Biological: rgp120/HIV-1 SF-2; Biological: rgp120/HIV-1MN

Study type: Interventional

Funder types: NIH

Identifiers

NCT00000779

11191 (Registry Identifier)

ACTG 214

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 13+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.