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A Study to Test the Safety of Recombinant Interleukin-2 (rIL-2) in HIV-Infected Children Clinical Trials Info presented on Clinical Trials Search is not intended to be a substitute for certified medical advice, visits or professional assistance using a real physician. We are not physicians. Always consult your dr. about A Study to Test the Safety of Recombinant Interleukin-2 (rIL-2) in HIV-Infected Children conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. A Study to Test the Safety of Recombinant Interleukin-2 (rIL-2) in HIV-Infected Children Clinical research trials and A Study to Test the Safety of Recombinant Interleukin-2 (rIL-2) in HIV-Infected Children health trials happen in many of localities throughout the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically measure the effectualness of new drugs. The function of the studies / projects is to resolve particular human medical questions. Clinical trials are a popular manner for mDs, government agencies, and private sector corporations to discover remedies for all varieties of circumstances, like A Study to Test the Safety of Recombinant Interleukin-2 (rIL-2) in HIV-Infected Children. A Study to Test the Safety of Recombinant Interleukin-2 (rIL-2) in HIV-Infected Children Clinical Trials and other clinical trials allow volunteers to obtain healthcare treatment options before they are available to the masses. Some times the participants undergo professional assistance for free of charge, and occasionally they are paid for their time. Sometimes there is a cost for a A Study to Test the Safety of Recombinant Interleukin-2 (rIL-2) in HIV-Infected Children clinical trial. Human subjects often get the best healthcare available for their A Study to Test the Safety of Recombinant Interleukin-2 (rIL-2) in HIV-Infected Children condition. Dangers are a reality, however, and may include additional or frequent mD visits, healthcare dangers (potentially life-jeopardising), and/or the treatment being ineffectual. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
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Home > "A" Clinical Trials Conditions > A Study to Test the Safety of Recombinant Interleukin-2 (rIL-2) in HIV-Infected Children  A Study to Test the Safety of Recombinant Interleukin-2 (rIL-2) in HIV-Infected Children
A Study to Test the Safety of Recombinant Interleukin-2 (rIL-2) in HIV-Infected Children
For Condition: HIV Infections
Status: No longer recruiting
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) , National Institute of Child Health and Human Development (NICHD)
Synopsis: The purpose of this study is to determine the safety and maximum tolerated dose (the highest dose that can be given safely) of recombinant Interleukin-2 (rIL-2) in HIV-infected children. This study also evaluates the effect of rIL-2 on the immune system of these patients. IL-2 is a substance naturally produced by the body's white blood cells that plays an important role in helping the body fight infection. HIV-infected patients do not produce enough IL-2, and it is hoped that the use of rIL-2 may improve immune system function in these patients. First, it is necessary to determine the safety and effectiveness of this drug in HIV-infected children.
Details: According to study records, IL-2 has not been tested in HIV-infected children. Experience with IL-2 in pediatric populations is extremely limited. Pahwa et al. gave 30,000 units/kg daily IV to a child with severe combined immunodeficiency. This dose was well tolerated and the patient improved clinically as well as immunologically. Part A is necessary to determine the maximum tolerated dose of IL-2 in infected children. Part B will determine the efficacy of the maximum tolerated dose in infected children. Part A: Children will receive rIL-2 intravenously for 5 days every 8 weeks for 3 cycles. The study will enroll 4 patients in each of 3 dose levels. Dose escalation may occur if all 4 patients in a dose level tolerate therapy without evidence of Grade 3 (or higher) toxicity. If 1 of 4 subjects in any dose level experiences at least Grade 3 toxicity, 2 additional patients will be enrolled in that dose level. If 1 of these 2 additional patients experiences at least Grade 3 toxicity, dose escalation will not proceed. NOTE: Once Part A is completed and the maximum tolerated dose is established, children who participated in Part A and received less than the maximum tolerated dose will be offered additional therapy consisting of 3 cycles of rIL-2 at the maximum tolerated dose. Part B: Children will receive rIL-2 intravenously at the maximum tolerated dose established in part A. Treatment will be given for 5 days every 8 weeks for 3 cycles. [AS PER AMENDMENT 6/4/98: Children will receive rIL-2 intravenously at the lowest dose for 5 days every 8 weeks for 6 cycles. Patients who received this dose in part A will also be offered this regimen.]
Eligibility:
Study Type: Interventional, Treatment, Randomized, Safety Study
Minimum Age/Maximum Age: 3 Years/12 Years
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Children may be eligible for this study if they: - Are HIV-positive. - Have decreased immune system functioning (CD4 count 500-1000 for 3- to 5-year-olds or CD4 count 200-500 for 6- to 12-year-olds). - Have symptomatic HIV infection. - Have a viral level less than 400 copies/ml. - Are between the ages of 3 and 12 (consent of parent or guardian required). Exclusion Criteria Children will not be eligible for this study if they: - Have an active opportunistic infection. - Are pregnant.
Total Enrollment: 27
Location and Contact Information:
Overall Study Official:
StuartStarr, Study Chair,
Bellevue Hosp / New York Univ Med Ctr
New York City, New York, 10016
United States
Univ of Florida Health Science Ctr / Pediatrics
Jacksonville, Florida, 32209
United States
Incarnation Children's Ctr / Columbia Presbyterian Med Ctr
New York City, New York, 10032
United States
Children's Hosp of Boston
Boston, Massachusetts, 021155724
United States
Univ of Chicago Children's Hosp
Chicago, Illinois, 606371470
United States
Chicago Children's Memorial Hosp
Chicago, Illinois, 606143394
United States
UCSF / Moffitt Hosp - Pediatric
San Francisco, California, 941430105
United States
Columbia Presbyterian Med Ctr
New York City, New York, 10032
United States
Children's Hosp of Denver
Denver, Colorado, 802181088
United States
Children's Hosp of Philadelphia
Philadelphia, Pennsylvania, 191044318
United States
Tulane Univ / Charity Hosp of New Orleans
New Orleans, Louisiana, 701122699
United States
Long Beach Memorial (Pediatric)
Long Beach, California, 90801
United States
Med College of Virginia
Richmond, Virginia, 23219
United States
Texas Children's Hosp / Baylor Univ
Houston, Texas, 77030
United States
Additional Information:
Study ID Numbers: ACTG 299; PACTG 299
Study Start Date:
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000849
Other Hiv Infections Studies:
1. The Effect of Valacyclovir on the Detection of HIV from Genital Herpes Lesions in HIV-Infected Patients
2. A Study of Dideoxycytidine Plus Zidovudine (AZT) in HIV-Infected Children Who Have Taken AZT
3. Randomized Comparative Study of Fluconazole Versus Clotrimazole Troches in the Prevention of Serious Fungal Infection in Patients With AIDS or Advanced AIDS-Related Complex. (A Nested Study of ACTG 081)
4. Treatment of Hepatitis B Virus (HBV) Before Beginning Anti-HIV Drugs in Patients with Both HBV and HIV
5. Comparison of Two Anti-HIV Regimens that Include One of Two Forms of Didanosine (ddI)
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Other HIV Infections Clinical Trials
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Other Jacksonville Clinical Trials
A Study to Test the Safety of Recombinant Interleukin-2 (rIL-2) in HIV-Infected Children
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