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:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002353
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: July 1997
  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: Endpoint Classification: Safety Study
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

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002353

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

No publications provided

ClinicalTrials.gov Identifier: NCT00002353     History of Changes
Other Study ID Numbers: 090, V103B
Study First Received: November 2, 1999
Last Updated: June 23, 2005
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on July 20, 2014