NCT00006153

Brief Summary

The purpose of this study is to see if giving a vaccine (Remune) is effective in HIV-positive patients who are also taking anti-HIV therapy. Regular treatment of HIV-positive patients with anti-HIV drugs slows the multiplication of the HIV virus in the body. A vaccine called Remune works to stop the virus infection by "boosting" the body's immune cell defense against the HIV virus before the virus enters cells. It also blocks the virus from entering the cells. This study will see whether Remune will improve the immune cell natural defense in patients who are also taking anti-HIV drugs.

Trial Health

35
At Risk

Trial Health Score

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

Enrollment
45

participants targeted

Target at P50-P75 for phase_1 hiv-infections

Geographic Reach
1 country

1 active site

Status
terminated

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

August 7, 2000

Completed
1.1 years until next milestone

First Posted

Study publicly available on registry

August 31, 2001

Completed
Last Updated

July 30, 2008

Status Verified

June 1, 2003

First QC Date

August 7, 2000

Last Update Submit

July 29, 2008

Conditions

HIV Infections

Keywords

HIV AntibodiesImmunity, CellularDrug Therapy, CombinationAnti-HIV AgentsremuneHIV Therapeutic Vaccine

Interventions

HIV-1 ImmunogenBIOLOGICAL

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients may be eligible for this study if they:
  • Are HIV-positive and started anti-HIV drugs soon after tests showed the presence of HIV.
  • Have been on an anti-HIV drug combination that includes a protease inhibitor for at least 3 months but no longer than 12 months.
  • Have 2 consecutive viral loads of less than 50 copies/ml, at least 30 days apart, within 90 days of study entry.
  • Are at least 16 years old (consent of parent or guardian required if under 18 years).
  • Agree to practice abstinence or use effective methods of birth control during the study.

You may not qualify if:

  • Patients will not be eligible for this study if they:
  • Are pregnant or breast-feeding.
  • Currently abuse alcohol or drugs.
  • Are currently being treated for some types of cancer.
  • Have any illness or condition that might interfere with the study or put them at risk.
  • Have received a vaccination 6 weeks before study entry.
  • Have previously received Remune.
  • Are taking medications that affect the immune system within 30 days of study entry.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Joanne Santangelo

San Diego, California, 92103, 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

  • Eric Daar

    PRINCIPAL INVESTIGATOR

  • Susan Little

    PRINCIPAL INVESTIGATOR

  • Janis Giorgi

    PRINCIPAL INVESTIGATOR

  • Rachel Schrier

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

August 7, 2000

First Posted

August 31, 2001

Last Updated

July 30, 2008

Record last verified: 2003-06

Locations

US(1)