Interleukin-2 Plus Anti-HIV Therapy in HIV-Infected Children With Weakened Immune Systems
NCT ID: NCT00006066
Last Updated: 2021-11-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
92 participants
INTERVENTIONAL
2006-06-30
Brief Summary
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IL-2 is an important substance produced by the body's white blood cells that helps the body fight infection. People with HIV infection do not produce enough IL-2. It is hoped that IL-2 treatment will help boost the immune system in people with HIV infection. It has not been studied very much in children and doctors need to know what doses are safe to give.
Detailed Description
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Part I: Patients add a 5-day course of subcutaneous IL-2 every 8 weeks for up to 48 weeks (6 cycles) to their HAART therapy. Three dose levels of IL-2 are administered. \[AS PER AMENDMENT 5/3/01: It is strongly recommended, but not required, that\] the first and second cycles of IL-2 are given in the hospital on an inpatient basis. The parent or patient is trained to give the injections and has the option of administering subsequent injections at home. Patients are monitored for CD4 and CD8 cell count and viral load. Enrollment into Part 1 begins at the lowest dose level; assuming no serious toxicities (Grade 3 or higher) occur, patients are enrolled into higher dose levels. The highest tolerated dose is established.
Part 2: After the highest tolerated dose is established in Part 1, additional patients are randomized to receive HAART alone (Arm 1), HAART with high-dose IL-2 (Arm 2), or HAART with low-dose IL-2 (Arm 3). High-dose IL-2 is given twice daily at the highest dose tolerated in Part 1 for 5 days every 8 weeks for 6 cycles. Low-dose IL-2 is given once a day every day for 48 weeks. For Arms 2 and 3 \[AS PER AMENDMENT 5/3/01: (except patients in the pharmacokinetic substudy), it is strongly recommended, but not required, that\] IL-2 is given the first week on an inpatient basis by hospital personnel. As in Part 1, there is the option of administering the remaining injections at home. Intensive toxicity monitoring, routine lymphocyte subsets, and quantitative HIV RNA are performed on all patients at specified time points during the study. The first 12 patients in Arms 2 and 3 have pharmacokinetic testing with frequent blood samples drawn at intervals, some of which require staying up to 12 hours at the clinic. Diphtheria/tetanus immunizations and bacteriophage phi X174 immunizations are administered to all patients to determine antibody responses.
Conditions
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Keywords
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Study Design
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TREATMENT
Interventions
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Diphtheria & Tetanus Toxoids & Acellular Pertussis Vaccine Adsorbed
Diphtheria and Tetanus Toxoids Adsorbed
Tetanus and Diphtheria Toxoids Adsorbed
Bacteriophage phi X 174
Aldesleukin
Eligibility Criteria
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Inclusion Criteria
* Is HIV-positive.
* Is 2 to 18 years old (consent of parent or guardian required if under 18).
* Has received 12 or more weeks of anti-HIV drug therapy, consisting of at least 3 drugs. This combination may include a nucleoside reverse transcriptase inhibitor (NRTI), a nonnucleoside reverse transcriptase inhibitor, or a protease inhibitor, or 3 NRTIs. Combinations of NRTIs may not include abacavir (ABC). Patients may have taken ABC if it was not in combination with 2 other NRTIs. (This reflects a change in the requirement for anti-HIV therapy.)
* Has a plasma HIV RNA level of less than 10,000 copies/ml.
* Has evidence of a weakened immune system (based on CD4 cell counts and absolute CD4 percentage less than 25 percent). (This reflects a change in how a weakened immune system is defined.)
* Has a parent or guardian who is willing to comply with study requirements.
* Has symptoms of HIV infection.
Exclusion Criteria
* Has an active opportunistic (AIDS-related) infection.
* Is pregnant.
* Is taking certain medications, such as steroids or other drugs that affect the immune system, within 6 weeks prior to study entry.
* Is taking ABC.
* Is taking certain antibodies.
2 Years
18 Years
ALL
No
Sponsors
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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Responsible Party
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Principal Investigators
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Savita Pahwa
Role: STUDY_CHAIR
Locations
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Long Beach Memorial Med. Ctr., Miller Children's Hosp.
Long Beach, California, United States
Usc La Nichd Crs
Los Angeles, California, United States
UCSD Maternal, Child, and Adolescent HIV CRS
San Diego, California, United States
UCSF Pediatric AIDS CRS
San Francisco, California, United States
Children's National Med. Ctr. Washington DC NICHD CRS
Washington D.C., District of Columbia, United States
Children's National Med. Ctr., ACTU
Washington D.C., District of Columbia, United States
Univ. of Miami Ped. Perinatal HIV/AIDS CRS
Miami, Florida, United States
USF - Tampa NICHD CRS
Tampa, Florida, United States
Tulane/LSU Maternal/Child CRS
New Orleans, Louisiana, United States
HMS - Children's Hosp. Boston, Div. of Infectious Diseases
Boston, Massachusetts, United States
Nyu Ny Nichd Crs
New York, New York, United States
Columbia IMPAACT CRS
New York, New York, United States
SUNY Upstate Med. Univ., Dept. of Peds.
Syracuse, New York, United States
Univ. of Puerto Rico Ped. HIV/AIDS Research Program CRS
San Juan, , Puerto Rico
Countries
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Other Identifiers
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10607
Identifier Type: REGISTRY
Identifier Source: secondary_id
PACTG 402
Identifier Type: -
Identifier Source: secondary_id
ACTG 402
Identifier Type: -
Identifier Source: org_study_id