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

Further Study Details: 

Expected Total Enrollment:  130

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.

Ages Eligible for Study:  13 Years and above,  Genders Eligible for Study:  Both

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.

California
      Stanford at Kaiser / Kaiser Permanente Med Ctr, San Francisco,  California,  94115,  United States
      Stanford Univ Med Ctr, Stanford,  California,  943055107,  United States
      UCLA CARE Ctr, Los Angeles,  California,  90095,  United States
      San Mateo AIDS Program / Stanford Univ, Stanford,  California,  943055107,  United States
      Santa Clara Valley Med Ctr / AIDS Community Rsch Consortium, San Jose,  California,  951282699,  United States
Colorado
      Univ of Colorado Health Sciences Ctr, Denver,  Colorado,  80262,  United States
Connecticut
      Yale Univ / New Haven, New Haven,  Connecticut,  065102483,  United States
Massachusetts
      Harvard (Massachusetts Gen Hosp), Boston,  Massachusetts,  02114,  United States
      Beth Israel Deaconess - West Campus, Boston,  Massachusetts,  02215,  United States
      Boston Med Ctr, Boston,  Massachusetts,  02118,  United States
New Jersey
      Children's Hosp of New Jersey / UMDNJ - New Jersey Med Schl, Newark,  New Jersey,  071072198,  United States
New York
      Bellevue Hosp / New York Univ Med Ctr, New York,  New York,  10016,  United States
Washington
      Univ of Washington, Seattle,  Washington,  981224304,  United States

Study chairs or principal investigators

Schooley RT,  Study Chair
Walker B,  Study Chair

Study ID Numbers:  ACTG 214
Record last reviewed:  October 2002
Last Updated:  October 13, 2004
Record first received:  November 2, 1999
ClinicalTrials.gov Identifier:  NCT00000779
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08