Interleukin-2 (IL-2) Treatment for HIV Infected Patients Who Have Interrupted Their Anti-HIV Drug Therapy
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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 |
- 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 |
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 |
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| United States, California | |
| UCLA CARE Center CRS | |
| Los Angeles, California, United States, 90502 | |
| Stanford CRS | |
| Palo Alto, California, United States, 94305-5107 | |
| Univ. of California Davis Med. Ctr., ACTU | |
| Sacramento, California, United States, 95814 | |
| UC Davis Medical Center | |
| 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 | |
| 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 Aldesleukin 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 Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents |
ClinicalTrials.gov processed this record on May 19, 2013