NCT00006495

Brief Summary

The purpose of this study is to see how the vaccines Remune (HIV-1 immunogen) and vCP1452 affect immune responses in patients who also are taking anti-HIV medications. This study also will see if these vaccines are safe to use either alone or in combination. Treatment with anti-HIV drugs does not always keep HIV viral load low and under control. This study will look at the effect of the HIV vaccine, vCP1452, on the immune response and how it works in combination with Remune. Information about immune responses and the safety of these vaccines in HIV-positive patients will be gathered.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P75+ for phase_1 hiv-infections

Geographic Reach
1 country

9 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 15, 2000

Completed
10 months until next milestone

First Posted

Study publicly available on registry

August 31, 2001

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2004

Completed
Last Updated

November 1, 2021

Status Verified

October 1, 2021

First QC Date

November 15, 2000

Last Update Submit

October 28, 2021

Conditions

HIV Infections

Keywords

PlacebosT-Lymphocytes, Helper-InducerAIDS VaccinesRNA, ViralHIV Core Protein p24T-Lymphocytes, CytotoxicAnti-HIV AgentsHIV Therapeutic Vaccine

Interventions

ALVAC(2)120(B,MN)GNP (vCP1452)BIOLOGICAL
HIV-1 ImmunogenBIOLOGICAL

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients may be eligible for Step I of this study if they:
  • Are at least 18 years old.
  • Are HIV-infected.
  • Have been on stable anti-HIV combination drug therapy for at least 12 weeks prior to screening for viral load and are willing to continue the same treatment during the study unless they experience side effects from the drugs and have a viral load increase.
  • Have a viral load lower than 50 copies/ml at screening. Patients must have had a viral load below 500 copies/ml for at least 12 weeks prior to screening.
  • Have a CD4 T cell count of at least 300 cells/mm3 within 30 days prior to study entry.
  • Agree to practice acceptable methods of birth control, including male and female condoms, a diaphragm, or an intra-uterine device (IUD), while on study treatment and for 12 weeks after study treatment is discontinued.
  • Patients may be eligible for Step II of this study if they:
  • Are enrolled in A5058s under A5057/A5058s, Versions 1.0 and 2.0.

You may not qualify if:

  • Patients will not be eligible for Step I of this study if they:
  • Are pregnant or breast-feeding.
  • Have an acute infection requiring antibiotics, an outbreak of a herpes virus, or other illness or surgery within 30 days prior to entry.
  • Have a long-term infection other than HIV.
  • Have cancer that may require systemic treatment.
  • Have had lymph node irradiation.
  • Have received any HIV vaccine.
  • Have used GM-CSF, G-CSF, M-CSF, IFN, IL-2, or similar medication within 30 days prior to entry.
  • Have used drugs affecting the immune system within 30 days prior to entry, or have an illness that may require use of these drugs.
  • Have had immunizations within 30 days prior to study entry.
  • Have received hydroxyurea within 30 days prior to study entry.
  • Are allergic to egg proteins or neomycin or have had other serious allergic reactions.
  • Work in close contact with canaries, or react to canarypox. Persons with a pet canary are not excluded.
  • Have had 2 viral load measurements in a row taken at least 14 days apart that were 500 copies/ml or higher in the 12 weeks prior to screening.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

UCLA CARE Center CRS

Los Angeles, California, 90095, United States

Location

Univ. of Miami AIDS CRS

Miami, Florida, 331361013, United States

Location

Johns Hopkins Adult AIDS CRS

Baltimore, Maryland, 21287, United States

Location

Massachusetts General Hospital ACTG CRS

Boston, Massachusetts, 02114, United States

Location

Beth Israel Deaconess Med. Ctr., ACTG CRS

Boston, Massachusetts, 02215, United States

Location

Univ. of Rochester ACTG CRS

Rochester, New York, 14642, United States

Location

Unc Aids Crs

Chapel Hill, North Carolina, 275997215, United States

Location

Hosp. of the Univ. of Pennsylvania CRS

Philadelphia, Pennsylvania, 19104, United States

Location

Univ. of Texas Medical Branch, ACTU

Galveston, Texas, 775550435, United States

Location

MeSH Terms

Conditions

HIV Infections

Interventions

HIV-1 immunogen, incomplete Freund's adjuvant

Condition Hierarchy (Ancestors)

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

Study Officials

  • Spyros Kalams

    STUDY CHAIR

  • Fred Valentine

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Masking
DOUBLE
Purpose
TREATMENT
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 15, 2000

First Posted

August 31, 2001

Study Completion

September 1, 2004

Last Updated

November 1, 2021

Record last verified: 2021-10

Locations

US(9)