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AIDS Related Cancers – NCI-06-C-0211

Dr. Robert Yarchoan
Principal Investigator

NCI’s Center for Cancer Research (CCR) is currently conducting the following trial for patients with AIDS related cancers. Click on the trial below for additional details, including a summary of primary eligibility, study outline, and information on how to contact Dr. Yarchoan and his staff directly.

You may also call the Clinical Trials Referral Office at 1-888-NCI-1937 (1-888-624-1937) to inquire about referring a patient to this trial.

A Pilot Study to Investigate the Safety and Immunogenicity of a Peptide Vaccine for HIV Infected HLA-A2 Individuals Designed to Impede Development of Antiretroviral Resistance
NCI-06-C-0211

  • Patients receive a subcutaneous vaccination at Weeks 0, 4, 8, 12, and 16 with 300μ (micrograms) E1M184V administered in Montanide ISA 51 or Montanide ISA 51 VG
  • Patients will also be administered 250μ sargramostim subcutaneously in the vaccination site immediately after the vaccinations and then daily for 3 additional days
  • The first 3 to 6 patients entered will not receive sargramostim with their first 2 doses of vaccine and Montanide ISA 51 or Montanide ISA 51 VG
  • Patients will be assessed for safety, clinical status, immunologic response to the vaccine, and virological status
  • After the vaccinations are complete, patients have the option of switching their antiretroviral regimen to one that includes lamivudine or emtricitabine and will be monitored for up to 2 years after the initiation of the vaccination for their immune response to the vaccine, virological status, and, if possible, the genotype of their HIV

Why is this trial important?

This study will test a novel approach to treating HIV that combines a peptide experimental therapeutic vaccine with antiretroviral therapy. The vaccine is designed to enhance immunity against an HIV mutation that caused resistance to certain drugs (such as lamivudine) and it is possible that this approach may help delay the development of resistance to certain antiretroviral drugs.

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