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

Completed · Phase 1

Conditions studied: HIV Infections

In brief

To evaluate an HIV lipopeptide immunotherapeutic, P3C541b, at two dose levels administered subcutaneously in HIV-seropositive patients.

Key facts

Study ID

NCT00002353

Run by

United Biomedical

Last updated by the study team

2005-06-24

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Beth Israel Hosp — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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