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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

Information source: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: HIV Infections

Intervention: Aldesleukin (Drug); ART (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: National Institute of Allergy and Infectious Diseases (NIAID)

Official(s) and/or principal investigator(s):
Kiat Ruxrungthum, Study Chair


The purpose of this study is to evaluate the safety and tolerability of giving IL-2 plus anti-HIV (antiretroviral) therapy to HIV-positive patients with CD4 cell counts (cells of the immune system that fight infection) of at least 350 cells/mm3. This study will also examine the ability of antiretroviral therapy combined with IL-2 to boost the immune system. 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.

Clinical Details

Official title: 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

Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

CD4 count

Laboratory and clinical adverse events

Detailed description: Interleukin-2 administered subcutaneously, in combination with antiretrovirals, results in an increased CD4+ cell count that might impact upon HIV disease progression. A Phase III trial involving large numbers of HIV-positive patients is the next step in the development process. To develop appropriate clinical experience with this combination, this Phase II trial will allow administration of IL-2 plus antiretroviral therapy to a small number of patients in sites being considered for the Phase III trial. Patients receive antiretrovirals alone or antiretrovirals plus IL-2 given subcutaneously. Three doses of IL-2 are studied, with 12 patients evaluated at each dose. When at least 9 of the first 12 patients complete the 5-day dosing period without dose-limiting toxicity, the next 12 patients are treated at the next highest dose every 12 hours for 5 days every 8 weeks; when this dose is tolerated, the last 12 patients randomized receive the highest study dose every 12 hours for 5 days every 8 weeks. Patients enrolled at the first two doses of IL-2 who complete three courses of treatment have their dose escalated to a maximum of the highest study dose.


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


Inclusion Criteria Patients may be eligible for this study if they:

- Are HIV-positive.

- Have a CD4 cell count greater than or equal to 300 cells/mm3.

- Have no AIDS-defining illnesses.

- Are at least 18 years old.

- Have been on antiretroviral therapy for at least 7 days prior to study entry.

Exclusion Criteria Patients will not be eligible for this study if they:

- 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 cancer (other than Kaposi's sarcoma), an AIDS-defining illness, a

central nervous system abnormality, or an autoimmune/inflammatory disease.

- Are pregnant or breast-feeding.

- Have ever received IL-2.

Locations and Contacts

Chulalongkorn Univ. Hosp. C603-010 CRS, Bangkok, Ratchathewi, Thailand

Siriraj Hospital C603-020 CRS, Bangkok, Ratchathewi, Thailand

Additional Information

Click here for more information about Aldesleukin

Haga clic aquí para ver información sobre este ensayo clínico en español.

Starting date: February 1998
Last updated: February 1, 2013

Page last updated: August 23, 2015

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