A Study to Evaluate the Effects of Giving IL-2 Alone to HIV-Positive Patients With CD4 Cell Counts of at Least 350 Cells/mm3 Who Do Not Wish to Receive Anti-HIV Therapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00000909
Recruitment Status : Completed
First Posted : August 31, 2001
Last Update Posted : May 22, 2012
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

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.

Condition or disease Intervention/treatment Phase
HIV Infections Drug: Aldesleukin Phase 2

Detailed Description:

Previous studies have shown that interleukin-2, when given under the skin, results in CD4+ cell count increases, and may impact upon disease progression. A Phase III trial is the next step in the development of these efficacy trials. One question, however, has not been addressed in previous IL-2 studies: whether it is both safe and reasonable to allow prospective IL-2 recipients the autonomy of choosing whether or not to take antiretrovirals in addition to their cytokine therapy. This trial addresses that concern.

In this open-label study, 36 patients are randomized to 1 of 3 treatment groups of 12 patients each:

Group I: IL-2 every 12 hours for 5 days every 8 weeks. Group II: IL-2 every 12 hours for 5 days every 8 weeks (higher IL-2 dose). Group III: Control group receiving no therapy. Patients must complete a minimum of 3 8-week cycles of treatment. Twelve patients are randomized to each arm. Following study completion, Group I and II patients may elect to continue receiving IL-2 during follow-up or as part of an additional protocol based on the results of this study.

[AS PER AMENDMENT 2/12/99: Patients who have received study medication and/or routine protocol visits and procedures for at least 6 months with acceptable compliance are eligible for continued follow-up in an extension phase. The extension phase will continue for at least 1 year from the date when the last patient has been enrolled in the extension phase. Patients originally randomized to IL-2 may continue to receive IL-2 during the extension period, with IL-2 therapy guided on an individual basis. Patients originally randomized to no therapy may continue to receive no therapy during the extension phase.] [AS PER AMENDMENT 7/11/00: Patients demonstrating acceptable compliance with routine visits and procedures during the initial treatment phase and/or extension phase may participate in the long-term follow-up phase which requires follow-up visits at least every 4 months for approximately 5 years. Patients originally randomized to Group 1 or 2 may continue to receive IL-2, with IL-2 therapy guided on an individual basis, during the long-term follow-up phase. Patients originally randomized to Group 3 may continue to receive no therapy during the long-term follow-up phase.]

Study Type : Interventional  (Clinical Trial)
Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Open Label Phase II Study of Subcutaneous Interleukin-2 (Proleukin) Alone vs No Therapy in Patients With HIV Infection and at Least 350 CD4+ Cells/mm3 Who Do Not Wish to Receive Treatment With Antiretroviral Therapy
Actual Study Completion Date : June 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
Drug Information available for: Aldesleukin

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria

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.

Exclusion Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00000909

United Kingdom
Kobler Ctr. of Chelsea Westminster Hosp. C604-030 CRS
London, United Kingdom
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Study Chair: Michael Youle
Study Chair: Jorge Tavel

Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID) Identifier: NCT00000909     History of Changes
Other Study ID Numbers: IRP 021D
10462 ( Registry Identifier: DAIDS ES )
First Posted: August 31, 2001    Key Record Dates
Last Update Posted: May 22, 2012
Last Verified: May 2012

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Dose-Response Relationship, Drug
CD4 Lymphocyte Count
RNA, Viral

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Antineoplastic Agents
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents