NCT00000820

Brief Summary

PRIMARY: To examine the effect of aldesleukin ( IL-2 ) on viral activity in the blood. To determine the safety of low-dose IL-2 in combination with antiretroviral therapy versus antiretroviral therapy alone. SECONDARY: To examine delayed type hypersensitivity responses to skin test antigens and antibody responses to protein and polysaccharide vaccines. The profound immune impairment that results from HIV-1 infection is due, at least in part, to the loss of CD4+ T cells and the cytokines these cells secrete, especially IL-2 and interferon-gamma. Antiretroviral agents do not directly address the problem of immune impairment. Replacement of IL-2 at nontoxic doses may prevent or delay clinical immunosuppression and its attendant opportunistic infections. Also, since patients with HIV-1 infection respond suboptimally to routine protein and polysaccharide immunizations, IL-2 may provide an adjuvant effect on vaccine responses.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
104

participants targeted

Target at P50-P75 for phase_2 hiv-infections

Geographic Reach
1 country

10 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 2, 1999

Completed
1.8 years until next milestone

First Posted

Study publicly available on registry

August 31, 2001

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2002

Completed
Last Updated

October 28, 2021

Status Verified

October 1, 2021

First QC Date

November 2, 1999

Last Update Submit

October 27, 2021

Conditions

HIV Infections

Keywords

Interleukin-2Drug Therapy, CombinationAIDS-Related ComplexAntiviral Agents

Interventions

AldesleukinDRUG

Eligibility Criteria

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

You may qualify if:

  • Concurrent Medication:
  • Allowed:
  • PCP prophylaxis.
  • Therapy for an opportunistic infection that develops on study, with the exception of foscarnet for CMV disease or resistant Herpes simplex.
  • Systemic corticosteroids ONLY IF given for no longer than 21 days for acute PCP.
  • Topical corticosteroids to areas separate from a skin test or IL-2 injection site.
  • Acyclovir up to 1000 mg/day as maintenance for recurrent genital Herpes.
  • Erythropoietin and filgrastim.
  • Antiemetics.
  • Antibiotics as clinically indicated.
  • Elective standard immunizations at week 8 or later.
  • Concurrent Treatment:
  • Allowed:
  • Local radiation therapy.
  • Prior Medication: Required:
  • +9 more criteria

You may not qualify if:

  • Co-existing Condition:
  • Patients with the following symptoms or conditions are excluded:
  • Malignancy requiring systemic or local cytotoxic chemotherapy.
  • Untreated thyroid disease.
  • Asthma requiring intermittent or chronic inhalation or systemic therapy.
  • Any medical condition that precludes study entry.
  • Concurrent Medication:
  • Excluded:
  • Antianginal agents such as nitrates, calcium channel blockers, beta blockers, and antiarrhythmics.
  • Systemic or local cytotoxic chemotherapy.
  • Interferons.
  • Interleukins other than study drug.
  • Pentoxifylline ( Trental ).
  • Acetylcysteine ( NAC ).
  • Sargramostim ( GM-CSF ).
  • +26 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Alabama Therapeutics CRS

Birmingham, Alabama, 35294, United States

Location

University of Colorado Hospital CRS

Aurora, Colorado, 80262, United States

Location

Indiana Univ. School of Medicine, Infectious Disease Research Clinic

Indianapolis, Indiana, 462025250, United States

Location

SUNY - Buffalo, Erie County Medical Ctr.

Buffalo, New York, 14215, United States

Location

Beth Israel Med. Ctr. (Mt. Sinai)

New York, New York, 10003, United States

Location

NY Univ. HIV/AIDS CRS

New York, New York, 10016, United States

Location

Cornell University A2201

New York, New York, 10021, United States

Location

Unc Aids Crs

Chapel Hill, North Carolina, 275997215, United States

Location

Case CRS

Cleveland, Ohio, 44106, United States

Location

Hosp. of the Univ. of Pennsylvania CRS

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

  • Vogler MA, Teppler H, Gelman R, Valentine F, Lederman MM, Pomerantz RJ, Pollard RB, Cherng DW, Gonzalez CJ, Squires KE, Frank I, Mildvan D, Mahon LF, Schock B; AIDS Clinical Trials Group 248 Study Team. Daily low-dose subcutaneous interleukin-2 added to single- or dual-nucleoside therapy in HIV infection does not protect against CD4+ T-cell decline or improve other indices of immune function: results of a randomized controlled clinical trial (ACTG 248). J Acquir Immune Defic Syndr. 2004 May 1;36(1):576-87. doi: 10.1097/00126334-200405010-00005.

    PMID: 15097300BACKGROUND

MeSH Terms

Conditions

HIV InfectionsAIDS-Related Complex

Interventions

aldesleukin

Condition Hierarchy (Ancestors)

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

Study Officials

  • Teppler H

    STUDY CHAIR

  • Pomerantz R

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 2, 1999

First Posted

August 31, 2001

Study Completion

March 1, 2002

Last Updated

October 28, 2021

Record last verified: 2021-10

Locations

US(10)