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

Inclusion Criteria

• •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
• •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