NCT00381875已完成1 期
A Pilot Study to Investigate the Safety and Immunogenicity of a Peptide Vaccine for HIV Infected HLA-A2 Individuals Designed to Impede the Development of Antiretroviral Resistance
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Impact of treatment on immune response, in terms of the difference between cytotoxic T-lymphocyte effector frequency, as measured by enzyme-linked immunospot (ELISPOT) at baseline and at week 20
研究概览
简要总结
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 work better. Colony-stimulating factors, such as GM-CSF, may increase the number of immune cells found in bone marrow or peripheral blood. Giving vaccine therapy together with incomplete Freund's adjuvant and GM-CSF may be an effective treatment for patients with HIV.
PURPOSE: This clinical trial is studying how well giving vaccine therapy together with incomplete Freund's adjuvant and GM-CSF works in treating patients with HIV.
详细描述
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 positive.
- Assess, preliminarily, the ability of E1M184V peptide vaccine to induce a cytotoxic T-cell response, defined by ELISPOT assay, in these patients.
Secondary
- Explore, preliminarily, the effect of this regimen on HIV viral load and CD4 count in these patients.
- Explore, preliminarily, the development of lamivudine or emtricitabine resistance in patients who subsequently receive lamivudine or emtricitabine.
- Explore, preliminarily, the ability of E1M184V peptide vaccine to induce a cytotoxic T-cell response as assessed by HLA-A2 class I tetramers and intracellular interferon gamma production after stimulation with E1M184V.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- 未提供
结局指标
主要结局
Impact of treatment on immune response, in terms of the difference between cytotoxic T-lymphocyte effector frequency, as measured by enzyme-linked immunospot (ELISPOT) at baseline and at week 20
次要结局
- Effects of treatment on viral load
- Sequencing of any resultant HIV strains
- CD4 counts for assessment of effects on HIV disease
研究者
研究点 (2)
Loading locations...
相似试验
终止
2 期
Vaccine Therapy, Paclitaxel, and Carboplatin in Treating Patients Who Are Undergoing Surgery for Stage III or Stage IV Ovarian Cancer, Primary Peritoneal Cancer, or Fallopian Tube CancerFallopian Tube CancerPrimary Peritoneal Cavity CancerOvarian CancerNCT00373217Craig L Slingluff, Jr6
已完成
1 期
Vaccine Therapy in Treating Patients With Stage III or Stage IV Breast CancerBreast CancerNCT00304096University of Virginia12
已完成
1 期
Vaccine Therapy and GM-CSF in Treating Patients With Acute Myeloid Leukemia, Myelodysplastic Syndromes, Non-Small Cell Lung Cancer, or MesotheliomaMalignant MesotheliomaMyelodysplastic SyndromesLung CancerLeukemiaPrimary Peritoneal Cavity CancerNCT00398138Memorial Sloan Kettering Cancer Center22
已完成
2 期
Vaccine Therapy in Treating Patients With Newly Diagnosed Glioblastoma MultiformeMalignant Neoplasms of BrainNCT00643097John Sampson40
Unknown
2 期
Vaccine Therapy in Treating Patients With Stage IIIB, Stage IV, or Recurrent Non-Small Cell Lung CancerLung CancerNCT00104780Epimmune