A Phase I Safety and Immunogenicity Trial of UBI HIV Lipopeptide Immunotherapeutic P3C541b in HIV-1 Seropositive Human Subjects

Inclusion Criteria

Patients must have:

• HIV positivity.
• CD4 count >= 500 cells/mm3.
• No evidence of AIDS, persistent diarrhea, fever, oral hairy leukoplakia, herpes varicella-zoster (multidermatomal), oral candidiasis, opportunistic infections, severe cytomegalovirus infection, or disseminated or chronic herpes simplex.
• Successful establishment of EBV transformed B lymphoblastoid cell line.

NOTE:

• Most patients in group 2 must possess one or more HLA types A33, B8, B27, or Bw62.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

• Active syphilis.
• Positive circulating hepatitis B virus antigen.
• Active clinically significant medical problems.
• Evidence of psychiatric, medical, or substance abuse problems that would affect ability to participate on study.
• Occupational or other responsibilities that would prevent completion of study.

Concurrent Medication:

Excluded:

• Other HIV immunotherapeutic.
• Zidovudine or analog.
• Investigational therapies for HIV.

Patients with the following prior conditions are excluded:

• History of cancer unless surgically excised with reasonable assurance of cure.
• History of anaphylaxis or other serious adverse reactions to vaccines.
• History of serious allergic reaction to any substance that required hospitalization or emergent medical care (e.g., Stevens-Johnson syndrome, bronchospasms, or hypotension).
• History of autoimmune disease or use of immunosuppressive medications.
• History of suicide attempts or past psychosis.

Prior Medication:

Excluded within the past 6 months:

• HIV immunotherapeutic.
• Zidovudine or analog.
• Investigational therapies for HIV. Illicit drug use within past 30 days.