A Study to Evaluate the Effects of Giving Interleukin-2 (IL-2) Plus Anti-HIV Therapy to HIV-Positive Patients With CD4 Cell Counts of at Least 350 Cells/mm3
A Randomized, Open-Label, Phase II Study of Subcutaneous Interleukin-2 (Proleukin) Plus Antiretroviral Therapy vs. Antiretroviral Therapy Alone in Patients With HIV Infection and at Least 350 CD4+ Cells/mm3
4 other identifiers
interventional
72
1 country
4
Brief Summary
To demonstrate the safety and tolerability of subcutaneously administered interleukin-2 (IL-2) plus antiretrovirals in patients with HIV infection and CD4 counts of 350 cells/mm3 or more. To demonstrate the immunological efficacy of subcutaneous IL-2 therapy plus antiretroviral therapy relative to antiretroviral therapy alone. IL-2, given through injection under the skin, in combination with anti-HIV therapy can increase CD4 cell counts. This study examines 3 doses of IL-2 in order to determine the safest and most effective dose to use.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 hiv-infections
Started Oct 1997
4 active sites
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
October 1, 1997
CompletedFirst Submitted
Initial submission to the registry
November 2, 1999
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 1999
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedOctober 29, 2021
October 1, 2021
2.2 years
November 2, 1999
October 27, 2021
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- You may be eligible for this study if you:
- Are HIV-positive.
- Have a CD4 cell count greater than or equal to 300 cells/mm3.
- Are at least 18.
- Have been on antiretroviral therapy for at least 7 days prior to study entry.
You may not qualify if:
- You will not be eligible for this study if you:
- Abuse alcohol or drugs, or have any serious psychiatric or medical illnesses that would affect your safety or ability to complete the study.
- Have a history of cancer (other than Kaposi's sarcoma), an AIDS-defining illness, a central nervous system (CNS) abnormality, or an autoimmune/inflammatory disease.
- Are pregnant or breast-feeding.
- Have ever received IL-2.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Hospital de Clinicas 'Jose de San Martin' C601-040 CRS
Ciudad de Buenos Aires, Buenos Aires, Argentina
Hospital F.J. Muniz C601-050 CRS
Ciudad de Buenos Aires, Buenos Aires, Argentina
Hospital General de Agudos J.M. Ramos Mejia CPCRA CRS
Ciudad de Buenos Aires, Buenos Aires, Argentina
Hospital Italiano de Buenos Aires C601-020 CRS
Ciudad de Buenos Aires, Buenos Aires, Argentina
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
M Losso
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Purpose
- TREATMENT
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 2, 1999
First Posted
August 31, 2001
Study Start
October 1, 1997
Primary Completion
December 1, 1999
Study Completion
December 1, 1999
Last Updated
October 29, 2021
Record last verified: 2021-10