NCT00000909

Brief Summary

The purpose of this study is to evaluate the safety and tolerability of giving interleukin-2 (IL-2) alone to HIV-positive patients with CD4 cell counts greater than 350 cells/mm3 who do not wish to receive anti-HIV (antiretroviral) therapy. This study will also determine if IL-2 given alone can increase CD4 cell counts or decrease the level of HIV in the blood. IL-2 (a protein found in the blood that helps boost the immune system) can result in increases in CD4 cell count (immune system cells that fight infection). IL-2 is normally given in combination with antiretroviral therapy to treat HIV infection; however, some HIV patients do not wish to take antiretrovirals. This study asks if it is safe and effective to take IL-2 alone to treat HIV infection.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at below P25 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

November 2, 1999

Completed
1.8 years until next milestone

First Posted

Study publicly available on registry

August 31, 2001

Completed
2.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2004

Completed
Last Updated

October 29, 2021

Status Verified

October 1, 2021

First QC Date

November 2, 1999

Last Update Submit

October 27, 2021

Conditions

HIV Infections

Keywords

Interleukin-2Dose-Response Relationship, DrugCD4 Lymphocyte CountRNA, Viral

Interventions

AldesleukinDRUG

Eligibility Criteria

Age18 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.
  • Have had at least one CD4 cell count greater than or equal to 350 cells/mm3 within 30 days of study entry.
  • Are at least 18 years old.
  • Agree to abstinence or use of effective methods of birth control 1 month before and during the study.

You may not qualify if:

  • Patients will not be eligible for this study if they:
  • Have a history of a potentially life-threatening autoimmune or inflammatory disease.
  • Abuse alcohol or drugs, or have any serious psychiatric or medical illnesses that would affect their safety or ability to complete the study.
  • Have a history of an AIDS-defining illness.
  • Have a history of cancer, other than Kaposi's sarcoma.
  • Have ever taken IL-2 or any antiretroviral medications.
  • Are pregnant.
  • Are taking certain medications, including anti-seizure medications.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kobler Ctr. of Chelsea Westminster Hosp. C604-030 CRS

London, United Kingdom

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

  • Michael Youle

    STUDY CHAIR

  • Jorge Tavel

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
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

June 1, 2004

Last Updated

October 29, 2021

Record last verified: 2021-10

Locations

GB(1)