NCT00002353

Brief Summary

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

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 2, 1999

Completed
1.8 years until next milestone

First Posted

Study publicly available on registry

August 31, 2001

Completed
Last Updated

June 24, 2005

Status Verified

July 1, 1997

First QC Date

November 2, 1999

Last Update Submit

June 23, 2005

Conditions

HIV Infections

Keywords

Vaccines, SyntheticAIDS Vaccines

Interventions

P3C541b LipopeptideBIOLOGICAL

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

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.
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beth Israel Hosp

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 2, 1999

First Posted

August 31, 2001

Last Updated

June 24, 2005

Record last verified: 1997-07

Locations

US(1)