Interleukin-2 Plus Anti-HIV Therapy in HIV-Infected Children With Weakened Immune Systems
- Conditions
- HIV Infections
- Registration Number
- NCT00006066
- Brief Summary
The purpose of this study is to determine the safety of a drug called interleukin-2 (IL-2) given with anti-HIV therapy in children with HIV infection. This study will also determine the best dose of IL-2 to give children.
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
One of the challenges in effective combination therapy in HIV-infected patients is the ability to achieve immune reconstitution. IL-2 is hypothesized to restore and/or preserve the immune system when added to potent antiretroviral regimens. This study will evaluate restoration of immune functions of CD4 cells and will also determine the best way to deliver IL-2 in a safe and effective way.
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 92
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (14)
Nyu Ny Nichd Crs
🇺🇸New York, New York, United States
Children's National Med. Ctr. Washington DC NICHD CRS
🇺🇸Washington, District of Columbia, 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
Univ. of Miami Ped. Perinatal HIV/AIDS CRS
🇺🇸Miami, Florida, United States
USF - Tampa NICHD CRS
🇺🇸Tampa, Florida, United States
HMS - Children's Hosp. Boston, Div. of Infectious Diseases
🇺🇸Boston, Massachusetts, United States
SUNY Upstate Med. Univ., Dept. of Peds.
🇺🇸Syracuse, New York, United States
Long Beach Memorial Med. Ctr., Miller Children's Hosp.
🇺🇸Long Beach, California, United States
Tulane/LSU Maternal/Child CRS
🇺🇸New Orleans, Louisiana, United States
Children's National Med. Ctr., ACTU
🇺🇸Washington, District of Columbia, United States
Columbia IMPAACT CRS
🇺🇸New York, New York, United States
Univ. of Puerto Rico Ped. HIV/AIDS Research Program CRS
🇵🇷San Juan, Puerto Rico