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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

Phase 1
18 Years
Not Enrolling
Nonneoplastic Condition

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Trial Information

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



- 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

- Assess, preliminarily, the ability of E1M184V peptide vaccine to induce a cytotoxic
T-cell response, defined by ELISPOT assay, in these patients.


- 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.

OUTLINE: This is a pilot study.

Patients receive vaccination comprising E1M184V peptide and incomplete Freund's adjuvant
subcutaneously (SC) on day 1 in weeks 0, 4, 8, 12, and 16. Patients also receive
sargramostim (GM-CSF) SC immediately after vaccination and once daily on days 1-4. Some
patients do not receive GM-CSF after the first 2 doses of vaccine. Treatment continues in
the absence of unacceptable toxicity.

Patients undergo blood collection at baseline and at 4, 12, 20, 36, and 52 weeks for
biomarker/laboratory analysis. Assays may include immunoenzyme techniques and viral

After completion of study treatment, patients are followed periodically for up to 2 years.

PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.

Inclusion Criteria


- 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


- 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


- 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

Type of Study:


Study Design:

Primary Purpose: Treatment

Outcome Measure:

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

Safety Issue:


Principal Investigator

Kathleen M. Wyvill, BSN, RN

Investigator Affiliation:

NCI - HIV and AIDS Malignancy Branch


United States: Food and Drug Administration

Study ID:




Start Date:

July 2006

Completion Date:

February 2011

Related Keywords:

  • Nonneoplastic Condition
  • HIV infection



Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office Bethesda, Maryland  20892-1182