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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00002353
First Posted: August 31, 2001
Last Update Posted: December 9, 2005
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
NIH AIDS Clinical Trials Information Service
  Purpose
To evaluate an HIV lipopeptide immunotherapeutic, P3C541b, at two dose levels administered subcutaneously in HIV-seropositive patients.

Condition Intervention Phase
HIV Infections Biological: P3C541b Lipopeptide Phase 1

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: A Phase I Safety and Immunogenicity Trial of UBI HIV Lipopeptide Immunotherapeutic P3C541b in HIV-1 Seropositive Human Subjects

Resource links provided by NLM:


Further study details as provided by NIH AIDS Clinical Trials Information Service:

Detailed Description:
Patients are randomized to receive P3C541b or placebo within each of two study groups. Enrollment in the first group will be independent of HLA type, whereas all but two of the patients enrolled in group 2 must have one or more HLA types A33, B8, B27, or Bw62. Treatment in group 2 will not begin until those in group 1 have reached day 14 without serious toxicity.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002353


Locations
United States, Massachusetts
Beth Israel Hosp
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
United Biomedical
  More Information

ClinicalTrials.gov Identifier: NCT00002353     History of Changes
Other Study ID Numbers: 090
V103B
First Submitted: November 2, 1999
First Posted: August 31, 2001
Last Update Posted: December 9, 2005
Last Verified: July 1997

Keywords provided by NIH AIDS Clinical Trials Information Service:
Vaccines, Synthetic
AIDS Vaccines

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases