NCT00013663

Brief Summary

The purpose of this study is to determine if HIV-specific canarypox vaccine and/or interleukin-2 (IL-2) will control viral load (amount of HIV in the blood) after HIV treatment is withdrawn for a certain time period.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
92

participants targeted

Target at P50-P75 for phase_2 hiv-infections

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

March 27, 2001

Completed
5 months until next milestone

First Posted

Study publicly available on registry

August 31, 2001

Completed
4.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2006

Completed
Last Updated

November 2, 2012

Status Verified

June 1, 2006

First QC Date

March 27, 2001

Last Update Submit

November 1, 2012

Conditions

HIV Infections

Keywords

Virus ReplicationHIV-1AIDS VaccinesRNA, ViralAvipoxvirusGenetic VectorsViral LoadaldesleukinAntiretroviral Therapy, Highly ActiveHIV Therapeutic VaccineTreatment Interruption

Outcome Measures

Primary Outcomes (1)

  • Mean log10 viral load for each experimental group from the average of 5 values obtained during Weeks 21 to 25 (8 to 12 weeks following HAART interruption

Secondary Outcomes (3)

  • Proportion of participants who relapse during the first 12 weeks following stopping of HAART

  • length of time to the termination of Step II among participants

  • changes in frequency, activation state, and HIV-specific functional capacity of T and NK cells in blood, as monitored by expression of intracellular cytokines during the first 12 weeks after stopping HAART, with respect to termination of Step II

Interventions

ALVAC(2)120(B,MN)GNP (vCP1452)BIOLOGICAL
AldesleukinDRUG

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients may be eligible for this study if they:
  • Are HIV-positive.
  • Are more than 18 years old.
  • Have been receiving their current HAART (2 or more anti-HIV drugs in combination) for more than 6 consecutive months.
  • Have a CD4 count of 200 cells/microL or more within the 12 months prior to entering the study and 400 cells/microL or more on 2 occasions at least 2 weeks apart within 30 days of entry.
  • Have never had a viral load higher than 2 million molecules/ml and have had the viral load controlled with HAART to less than 50 molecules/ml on 2 occasions at least 2 weeks apart within 30 days of entry.
  • Have not had virologic failure on the current HAART regimen.
  • Have a negative urine pregnancy test within 14 days of entering the study.

You may not qualify if:

  • Patients will not be eligible for this study if they:
  • Have a current AIDS-defining illness.
  • Have had failure of the current HAART regimen (viral load higher than 10,000 molecules/ml).
  • Have a history of using agents affecting the immune system.
  • Have active uncontrolled heart disease.
  • Have had IL-2 therapy within 4 weeks of entering the study.
  • Have received other treatment that affects the immune system within 4 weeks of entry.
  • Have a history of a cancer requiring chemotherapy.
  • Have untreated thyroid disease, within 4 weeks of entering the study.
  • Have uncontrolled allergic disorders or autoimmune diseases, including asthma, inflammatory bowel disease, and psoriasis.
  • Abuse substances that may interfere with the ability to follow study requirements.
  • Are allergic to eggs.
  • Have hepatitis B or hepatitis C.
  • Are pregnant or breast-feeding.
  • Work in close contact with canaries, such as a job at breeding farms or bird shops.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New York Hosp - Cornell Med Ctr

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

HIV Infections

Interventions

aldesleukin

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

  • Kendall A. Smith, MD

    Division of Immunology, Department of Medicine, Weill Medical College, Cornell University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Masking
DOUBLE
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

March 27, 2001

First Posted

August 31, 2001

Study Completion

June 1, 2006

Last Updated

November 2, 2012

Record last verified: 2006-06

Locations

US(1)