HIV Infection Clinical Trial
Official title:
Phase I Protocol for the Evaluation of the Safety and Immunogenicity of Vaccination With Synthetic HIV Envelope Peptides in Patients With Early Human Immunodeficiency Virus Infection
Synthetic HIV Peptide Vaccines (Treatment Protocol)
We are conducting a study to evaluate the safety of two peptide vaccines (given alone or in
combination) in patients with early HIV infection. Patients entered onto the study must have
>500 CD4 cells/mm(3) and have preserved cardiac, hepatic, renal, and bone marrow function.
Patients must be off all anti-retroviral therapy for at least 6 months and may not have
received any experimental HIV vaccines. The vaccines being testing in this trial are
comprised of short peptide segments of the HIV envelope, including the V3 loop. In animal
studies, the peptides were able to induce neutralizing antibodies as well as cytotoxic T
responses to HIV. This will be the first trial in which they are given to humans. The study
will last for approximately one year, during which time the volunteers will receive 6
peptide vaccines under the skin. For more information, please call Tino Merced-Galindez,
R.N. at (301) 496-8959 or Dr. Richard Little at (800) 772-5464.
Assessment of toxicity and immunogenicity of two HIV-1 derived peptide vaccines in Montanide ISA-51 (incomplete Freund's adjuvant) given singly and in combination. ;
Endpoint Classification: Safety Study, Primary Purpose: Treatment
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