Interleukin-2 (IL-2) Treatment for HIV Infected Patients Who Have Interrupted Their Anti-HIV Drug Therapy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00038259
First received: May 29, 2002
Last updated: May 9, 2012
Last verified: May 2012
  Purpose

When an HIV infected person taking strong anti-HIV drugs temporarily stops taking them, viral load rises and the body's immune system is exposed to more HIV. This may lead to the body mounting a better immune response against the virus. The purpose of this study is to find out if taking interleukin-2 (also called IL-2 or aldesleukin) while stopping anti-HIV drugs for short periods of time can help patients control their HIV viral load.

Study hypothesis: Patients in this study will have lower virologic rebound and will maintain their CD4 cell counts for a longer time than other patients in comparative studies.


Condition Intervention
HIV Infections
Drug: Aldesleukin

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Exploratory, Open-Label, Randomized Trial to Evaluate the Ability of Interleukin-2 (IL-2) to Enhance HIV-Specific Immunity and Influence the Time to Virologic Relapse Following Withdrawal of Potent Antiretroviral Therapy

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Primary Outcome Measures:
  • Mean of log10 HIV-1 RNA copies/ml obtained at Weeks 11 and 12 following the final interruption of potent antiretroviral therapy

Estimated Enrollment: 21
Study Completion Date: May 2006
Detailed Description:

Structured treatment interruptions (STIs) may stimulate an anti-HIV immune response. Evidence suggests that IL-2, which increases CD4 counts, could also enhance specific immune responses to HIV. Enhanced immune responses could influence the magnitude of and the time to virologic rebound following treatment discontinuation. This study will compare the viral loads present after 12 weeks of an antiretroviral therapy (ART) interruption period between patients who have received different dosing regimens of IL-2 and have taken part in at least two STIs.

This study will last 40 to 104 weeks. IL-2 is provided as part of this study; potent ART is not provided. Patients in this study will receive potent ART with at least two scheduled potent ART interruptions. Patients will be randomly assigned to one of two treatment arms. Arm A patients will receive low-dose injections of IL-2 for 3 weeks, during the last 2 weeks of potent ART interruption periods and the first week of restarting potent ART. Arm B patients will receive high-dose injections of IL-2 during the first 5 days of restarting potent ART after the interruption period. The first two ART interruptions are 4 weeks in duration, followed by 12 weeks back on ART. Depending on the patient's viral load and CD4 count at Week 32, patients will either enter a third potent ART interruption for 12 to 48 weeks or will continue ART. No IL-2 will be given with the third scheduled potent ART interruption. Throughout the study, participants will have physical exams and laboratory tests, including measurements of viral load and CD4 count.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Note: ACTG A5132 closed to accrual on 11/01/04.

Inclusion Criteria:

  • HIV infected
  • CD4 cell count of 300 cells/mm3 or more within 30 days prior to study entry
  • HIV viral load of less than 50 copies/ml within 30 days prior to study entry
  • Anti-HIV drug regimen of at least 3 anti-HIV drugs for at least 6 months immediately prior to study entry
  • Documented pretherapy plasma HIV viral load measured within 6 months of starting ART
  • Willing to use acceptable methods of contraception

Exclusion Criteria:

  • HIV viral load of 50 copies/ml or more within 60 days before study entry
  • Current use of experimental anti-HIV drugs other than FDA sanctioned investigational drugs
  • Abacavir as part of anti-HIV regimen within 8 weeks prior to study entry
  • Pregnant or breastfeeding
  • History of autoimmune disease, except for stable autoimmune thyroid disease
  • Heart problems or on certain medications for treatment of heart problems
  • Cancer requiring chemotherapy
  • Untreated thyroid disease
  • Disease of the central nervous system that has been active within 1 year prior to study entry
  • Uncontrolled diabetes
  • Allergies to the study medications
  • Other illnesses that would make it inappropriate for patients to participate in the study
  • Immunomodulatory therapy within 4 weeks prior to study entry
  • Hydroxyurea within 6 months prior to study entry
  • Drug or alcohol use that, in the opinion of the investigator, would interfere with the study
  • Psychiatric or mental impairment that would affect compliance
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00038259

Locations
United States, California
UCLA CARE Center CRS
Los Angeles, California, United States, 90502
Stanford CRS
Palo Alto, California, United States, 94305-5107
UC Davis Medical Center
Sacramento, California, United States, 95814
Univ. of California Davis Med. Ctr., ACTU
Sacramento, California, United States, 95814
Santa Clara Valley Med. Ctr.
San Jose, California, United States, 94305-5107
San Mateo County AIDS Program
San Mateo, California, United States, 94305-5107
United States, Florida
Univ. of Miami AIDS CRS
Miami, Florida, United States, 33136-1013
United States, Hawaii
Univ. of Hawaii at Manoa, Leahi Hosp.
Honolulu, Hawaii, United States, 96816
United States, Ohio
MetroHealth CRS
Cleveland, Ohio, United States
United States, Texas
Univ. of Texas Medical Branch, ACTU
Galveston, Texas, United States, 775550435
Sponsors and Collaborators
Investigators
Study Chair: Richard M. Pollard, MD University of California, Davis
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00038259     History of Changes
Other Study ID Numbers: A5132, 10081
Study First Received: May 29, 2002
Last Updated: May 9, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Interleukin-2
Drug Administration Schedule
CD4 Lymphocyte Count
Anti-HIV Agents
Viral Load
Treatment Interruption
Treatment Experienced
STI

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
Interleukin-2
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents

ClinicalTrials.gov processed this record on October 01, 2014