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Safety, Tolerability, and Anti-HIV Activity of PEG-Intron in HIV-Positive Children Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified medical advice, visits or professional assistance with a genuine dr.. We are not doctors. Always consult your mD about Safety, Tolerability, and Anti-HIV Activity of PEG-Intron in HIV-Positive Children conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Safety, Tolerability, and Anti-HIV Activity of PEG-Intron in HIV-Positive Children Clinical research trials and Safety, Tolerability, and Anti-HIV Activity of PEG-Intron in HIV-Positive Children medical trials take place in many of places throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the effectiveness of new does drugs. The purpose of the studies / projects is to solve specific human healthcare questions. Clinical trials are a popular way for mDs, government agencies, and private sector companies to find cures for all varieties of conditions, like Safety, Tolerability, and Anti-HIV Activity of PEG-Intron in HIV-Positive Children. Safety, Tolerability, and Anti-HIV Activity of PEG-Intron in HIV-Positive Children Clinical Trials and other clinical trials allow for volunteers to have health treatment options before they are available to the masses. Many times the human subjects acquire professional assistance for free of charge, and sometimes they are compensated for their time. Occasionally there is a cost for a Safety, Tolerability, and Anti-HIV Activity of PEG-Intron in HIV-Positive Children clinical trial. Test subjects typically obtain the finest healthcare available for their Safety, Tolerability, and Anti-HIV Activity of PEG-Intron in HIV-Positive Children condition. Dangers are a reality, nevertheless, and might include additional or frequent doctor trips, medical dangers (possibly life-jeopardising), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials patients.
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Home > "S" Clinical Trials Conditions > Safety, Tolerability, and Anti-HIV Activity of PEG-Intron in HIV-Positive Children  Safety, Tolerability, and Anti-HIV Activity of PEG-Intron in HIV-Positive Children
Safety, Tolerability, and Anti-HIV Activity of PEG-Intron in HIV-Positive 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 see if PEG-Intron is safe and tolerated when given to children, to see how much gets into the blood and how long it stays in the blood, and to see how well it works to reduce viral load (level of HIV in the blood). PEG-Intron is an experimental drug that works differently than other anti-HIV medications. It decreases the ability of HIV to infect the T cells (a special type of cell that helps fight infection). PEG-Intron has been approved by the Food and Drug Administration (FDA) to treat hepatitis C in adults, but in this study, it is being used as an investigational agent for the treatment of HIV/AIDS. It has not been tested in children before and experience with PEG-Intron in adults is limited. (This protocol has been changed to reflect FDA approval of PEG-Intron for treating hepatitic C in adults.)
Details: The current optimal clinical management of HIV infection involves therapy with combinations of nucleoside and nonnucleoside reverse transcriptase inhibitors and HIV protease inhibitors. These regimens, though effective, do not completely eliminate HIV and the development of drug resistance is a major clinical problem. Interferons have been proposed as a possible treatment of HIV. Interferon-alfa inhibits HIV replication in vitro, and HIV-infected patients appear to have reduced production of interferons. Previous short-term clinical studies in adults showed anti-HIV activity, although there were safety and tolerability problems associated with the higher dose regimens used. This study will utilize a rising multiple-dose design to assess the safety, tolerability, and pharmacokinetics of single and multiple doses of PEG-Intron in HIV-infected children. In a dose-escalation study, patients add weekly PEG-Intron to their antiretroviral therapy for up to 6 weeks. The first 2 doses are received in the clinic where parents/guardians are trained to administer injections, and succeeding doses are given at home. Patients are enrolled from 2 cohorts. An older cohort of ages 2 to 16 years receives PEG-Intron at the lowest drug level. If the dose is tolerated, patients are added and if safety criteria are met, patients are enrolled in the next higher dose level. The dose level will be increased similarly for up to 4 doses. An optimal dose level is chosen. Cohort II patients are a younger group ranging from 3 months to under 2 years of age. Patients initially receive the next lower PEG-Intron dose to the optimal dose identified in Cohort I [AS PER AMENDMENT 07/23/01: or 1 microg/kg if the optimal dose proves to be 1 microg/kg]. If this dose is safely tolerated, additional patients are added. If this dose level meets safety criteria, patients are enrolled to receive the optimal dose level. Patients are evaluated with the same safety criteria as Cohort I. Patients in both cohorts who have at least a 0.5 log reduction in HIV RNA at 28 days of treatment are offered continued treatment for a total of 60 weeks.
Eligibility:
Study Type: Interventional, Treatment, Dose Comparison, Pharmacokinetics Study
Minimum Age/Maximum Age: 3 Months/16 Years
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Patients may be eligible for this study if they: - Are HIV-infected infants and children aged 3 months to 16 years. - Have been on stable anti-HIV drugs for at least 16 weeks if over 6 months of age. Infants aged 3 to 6 months must be on stable anti-HIV drugs for at least 6 weeks. Children should be receiving at least 3 anti-HIV drugs. - Have a viral load of more than 5,000 copies/ml. - Have written informed consent from parent or guardian and, if able, can give written consent themselves. - Are able to follow the schedule in the protocol. - Have a parent/guardian who is willing to comply with study requirements. - (This study has been changed to allow any combination of 3 anti-HIV drugs and to remove CD4 requirements.) Exclusion Criteria Patients will not be eligible for this study if they: - Are breast-feeding or pregnant or not using birth control, if a female. - Have abnormal thyroid activity. - Have severe HIV symptoms. - Have opportunistic (AIDS-related) infections or history of such infections within the preceding 2 months. - Have participated in a clinical trial of an experimental drug in the previous month. - Have a positive test result for hepatitis B or C. - Have an allergy to E. coli. - Have a mental disorder. - Have a history of drug dependence and measure positive when screened.
Total Enrollment: 54
Location and Contact Information:
Overall Study Official:
KatherineLuzuriaga, Study Chair,
UCSF / Moffitt Hosp - Pediatric
San Francisco, California, 941430105
United States
Long Beach Memorial (Pediatric)
Long Beach, California, 90801
United States
Children's Hosp of Boston
Boston, Massachusetts, 021155724
United States
Harlem Hosp Ctr
New York City, New York, 10037
United States
Univ of Massachusetts Med School
Worcester, Massachusetts, 016550001
United States
Univ of Medicine & Dentistry of New Jersey / Univ Hosp
Newark, New Jersey, 071032714
United States
Connecticut Children's Med Ctr
Farmington, Connecticut, 060303805
United States
Baystate Med Ctr of Springfield
Springfield, Massachusetts, 01199
United States
Schneider Children's Hosp
New Hyde Park, New York, 11040
United States
Children's Hosp of Los Angeles/UCLA Med Ctr
Los Angeles, California, 900276016
United States
Texas Children's Hosp / Baylor Univ
Houston, Texas, 77030
United States
Los Angeles County - USC Med Ctr
Los Angeles, California, 90033
United States
SUNY Health Sciences Ctr at Syracuse / Pediatrics
Syracuse, New York, 13210
United States
Univ of Florida Health Science Ctr / Pediatrics
Jacksonville, Florida, 32209
United States
Univ of Miami (Pediatric)
Miami, Florida, 33161
United States
Additional Information:
Study ID Numbers: ACTG P1017; PACTG P1017
Study Start Date:
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006325
Other Hiv Infections Studies:
1. A Clinical Research Study Of FDA-Approved HIV Drugs In HIV-Infected Patients Who Have Not Received Prior Therapy
2. A Study to Evaluate the Effects of Different Methods of Birth Control on the Drug Actions of Zidovudine (an Anti-HIV Drug) in HIV-Positive Women and to Compare Zidovudine Metabolism in Men and Women
3. A Pilot Study of OPC-8212 (Vesnarinone) in Persons With AIDS-Related Kaposi's Sarcoma
4. Once-Daily Drug Regimen for HIV-Infected Patients
5. The Effects of Combination Anti-HIV Medication on Human Papillomavirus (HPV) in HIV-Infected Women
Related Studies:
Other HIV Infections Clinical Trials
Other Texas Clinical Trials
Other Houston Clinical Trials
Safety, Tolerability, and Anti-HIV Activity of PEG-Intron in HIV-Positive Children
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