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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00000779

Enrollment

130

Registered

2001-08-31

Start date

Unknown

Completion date

1996-09-30

Last updated

2021-11-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections

Keywords

Vaccines, Synthetic, HIV-1, Adjuvants, Immunologic, AIDS-Related Complex, HIV Envelope Protein gp120, AIDS Vaccines, HIV Therapeutic Vaccine

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.

Interventions

BIOLOGICALrgp120/HIV-1 SF-2

BIOLOGICALEnv 2-3

BIOLOGICALAluminum hydroxide

BIOLOGICALMF59

BIOLOGICALrgp120/HIV-1IIIB

BIOLOGICALrgp120/HIV-1MN

Study design

Allocation

RANDOMIZED

Primary purpose

PREVENTION

Eligibility

Sex/Gender

ALL

Age

13 Years to No maximum

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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026