Status:
COMPLETED
Vaccine Therapy, Incomplete Freund's Adjuvant, and GM-CSF in Treating Patients With HIV
Lead Sponsor:
National Institutes of Health Clinical Center (CC)
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Nonneoplastic Condition
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
RATIONALE: Vaccines made from peptides may help the body build an effective immune response. Incomplete Freund's adjuvant may stimulate the immune system in different ways and may help the vaccine wor...
Detailed Description
OBJECTIVES: Primary * Assess the safety of vaccination comprising E1M184V peptide with incomplete Freund's adjuvant in combination with sargramostim (GM-CSF) in patients with HIV who are HLA-A2 posi...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
July 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2011
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00381875
Start Date
July 1 2006
End Date
February 1 2011
Last Update
May 2 2012
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office
Bethesda, Maryland, United States, 20892-1182