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Investigator(s):
Robert Yarchoan, M.D. Principal Investigator Phone: 301-496-8959 yarchoan@helix.nih.gov	Thomas Uldrick, M.D. Lead Associate Investigator Phone: 301-496-8959 uldrickts@mail.nih.gov
Referral Contact(s):
Kathy Wyvill, R.N. Research Nurse Phone: 301-496-8959 1-800-243-2732 ext. 4 (Toll Free) Fax: 301-402-7552 wyvillk@mail.nih.gov	Karen Aleman, R.N., B.S.N. Research Nurse Phone: 301-496-8959 1-800-243-2732 ext. 4 (Toll Free) Fax: 301-402-7552 alemank@mail.nih.gov

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Primary Eligibility:

• HIV-1 infection confirmed by Western Blot and ELISA
• HLA A2 confirmed by PCR-SSP Method
• CD4 T-cell count ≥ 300 cells/mm³ within 2 weeks of enrollment
• Patients must be on a stable regimen of highly active antiretroviral therapy that does not include lamivudine or emtricitabine for at least 1 month prior to enrollment or be willing to switch to such a regimen
• Patients must have a viral load < 50 copies/ml for 1 month prior to enrollment
• Patients with current hepatitis B surface antigen or with a prior history of hepatitis B surface antigen are ineligible
• No previous vaccination with a vaccine that includes all or part of the reverse transcriptase of HIV-1

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Study Outline:

• 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

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Additional Information:

• This trial will be conducted at the NIH Clinical Center in Bethesda, MD. It is open to patients who meet the eligibility requirements, regardless of where they live in the United States.
• There is no charge for medical care received at NIH Clinical Center.
• FAQs about this study - provides information for patients about the trial such as frequency and duration of visits, costs, how to enroll, treatment plan.
• PDQ (Physicians Data Query) - provides additional details about this study for health care providers.

Reviewed: 6/12/09
Updated: 7/30/09