NCT00056797

Brief Summary

This study will evaluate whether the HIV vaccine ALVAC vCP1452 given in combination with interleukin-2 (IL-2), also known as aldesleukin, can increase immune system function in people with HIV infection.

Trial Health

87
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

Timeline
Completed

Started Mar 2002

Typical duration 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2002

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

March 24, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 25, 2003

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2006

Completed
Last Updated

December 14, 2016

Status Verified

July 1, 2007

Enrollment Period

4 years

First QC Date

March 24, 2003

Last Update Submit

December 13, 2016

Conditions

HIV Infections

Keywords

HIV Therapeutic vaccineIL-2Structured Treatment InterruptionTreatment Experienced

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, corresponding to 8 to 12 weeks following the interruption of HAART

Secondary Outcomes (3)

  • Proportion of subjects who relapse during the first 12 weeks following cessation of HAART

  • length of time to the termination of Step II

  • changes in frequency, activation state, and HIV-specific functional capacity of T cells and NK cells in blood, as monitored by the expression of intracellular cytokines during the first 12 weeks after cessation of HAART

Interventions

ALVAC HIV vaccine (vCP1452)BIOLOGICAL
Interleukin-2DRUG

Eligibility Criteria

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

You may qualify if:

  • HIV infected
  • Stable HAART, defined as two or more antiretroviral drugs in combination. Changes in drugs are allowed if for any reason other than virologic failure.
  • CD4 cell count \> 200 cells/ml for the 12 months prior to enrollment
  • CD4 cell count \>= 400 cells/ml on two successive occasions at least 14 days apart within 30 days of study entry
  • HIV RNA \< 2 million copies/ml, with suppression on HAART to \< 50 copies/ml on two successive occasions at least 14 days apart within 30 days of entry
  • Acceptable methods of contraception

You may not qualify if:

  • Current AIDS-defining illness
  • Virologic failure (HIV RNA \> 10,000 copies/ml) while receiving current HAART regimen
  • Immunomodulating agents, including interleukins; antibodies reactive with lymphocytes, monocytes, or antigen presenting cells; and polyribonucleotides
  • IL-2 therapy within 4 weeks of study entry
  • Uncontrolled active cardiac, renal, pulmonary, hepatic, or CNS disease
  • History of active malignancy requiring chemotherapy
  • History of thyroid disease or autoimmune disorders, including asthma, inflammatory bowel disease, rheumatoid arthritis, and psoriasis
  • Active infection with hepatitis B virus or hepatitis C virus
  • Severe retinopathy due to diabetes, hypertension, CMV, or macular degeneration
  • Serious infection or other serious medical illness that is potentially life threatening and requires systemic therapy and/or hospitalization within 14 days of study entry
  • Substance abuse that will compromise the participant's ability to adhere to the study requirements
  • Current alcohol use of more than 1 drink/day any time during 6 months prior to study entry. One drink is defined as 12 ounces of beer, 5 ounces of wine, or 1.25 ounces of hard liquor.
  • History of allergy to eggs, IL-2, or other components of the vaccine or IL-2 formulation
  • Pregnant or breast-feeding
  • Professionals working in close contact with canaries (e.g., breeding farms, bird shops)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NY Presbyterian Weill Cornell Medical Center

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

HIV Infections

Interventions

Interleukin-2

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

InterleukinsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsLymphokinesProteinsBiological Factors

Study Officials

  • Kendall A. Smith, MD

    Weill Medical College of Cornell University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
NIH

Study Record Dates

First Submitted

March 24, 2003

First Posted

March 25, 2003

Study Start

March 1, 2002

Primary Completion

March 1, 2006

Study Completion

March 1, 2006

Last Updated

December 14, 2016

Record last verified: 2007-07

Locations

US(1)