Vaccine Therapy, Incomplete Freund's Adjuvant, and GM-CSF in Treating Patients With HIV

DISEASE CHARACTERISTICS:

• HIV-1 infection confirmed by Western blot and enzyme-linked immunosorbent assay
• HLA-A2 positive by polymerase chain reaction-sequence specific primers
• CD4 T-cell count ≥ 300/mm³

• Must be receiving stable regimen of highly active antiretroviral therapy (HAART) that does not include lamivudine or emtricitabine for ≥ 1 month prior to study entry

  • Patients on HAART, including lamivudine or emtricitabine, for which there is a medically appropriate regimen that does not include lamivudine or emtricitabine, are eligible if willing to change antiretrovirals
• Viral load \< 50 copies/mL for 1 month prior to study entry

PATIENT CHARACTERISTICS:

• See Disease Characteristics
• ECOG performance status 0-1
• Life expectancy ≥ 6 months
• Hemoglobin ≥ 9 g/dL
• WBC ≥ 1,000/mm³
• Absolute neutrophil count ≥ 750/mm³
• Platelet count ≥ 75,000/mm³
• PT and PTT ≤ 120% of control unless lupus anticoagulant detected
• Bilirubin ≤ 1.5 times upper limit of normal (ULN) (≤ 7.5 mg/dL with direct fraction ≤ 0.7 mg/dL if on protease inhibitor therapy or due to Gilbert's syndrome)
• AST and ALT ≤ 2.5 times ULN
• Creatinine ≤ 1.5 mg/dL OR creatinine clearance ≥ 60 mL/min
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception

• No hepatitis B surface antigen (HBsAg) or a prior history of HBsAg while on lamivudine or emtricitabine

  • Prior treatment with tenofovir and currently HBsAg negative allowed
• No evidence of a severe or life-threatening infection other than HIV within the past 6 months
• No opportunistic infections requiring systemic therapy within the past month
• No active malignancy, except for basal cell carcinoma
• No known hypersensitivity to incomplete Freund's adjuvant or incomplete Freund's adjuvant VG (vegetable-grade), E1M184V peptide, or sargramostim (GM-CSF)

• No other abnormality that would be scored as ≥ grade 3 toxicity, except any of the following (if asymptomatic):

  • Hyperuricemia of grade 4 (without physiologic consequences)
  • Elevation of lactate dehydrogenase ≥ grade 3
  • Elevation of creatine phosphokinase (CPK) ≥ grade 3
  • Hypophosphatemia ≥ grade 3 (if patient is on tenofovir)
  • Elevation of alkaline phosphate of grade 3

  • Hyperamylasemia of ≥ grade 3 allowed if any of the following criteria are met:

    • Macroamylasemia
    • Lipase ≤ 2 times ULN
  • Lymphopenia grade 3
• No other condition that, in the opinion of the investigator, would preclude compliance with study requirements

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

• No systemic corticosteroids within the past 3 weeks

  • Concurrent systemic corticosteroids allowed in the short term only
  • Physiologic replacement doses of steroids allowed
• No prior vaccination with a vaccine that includes all or part of the reverse transcriptase of HIV-1
• No other concurrent investigational drugs or vaccinations
• No concurrent lamivudine or emtricitabine