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Sponsors and Collaborators: |
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) National Institute on Drug Abuse (NIDA) National Institute of Mental Health (NIMH) National Institute on Alcohol Abuse and Alcoholism (NIAAA) |
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Information provided by: | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
ClinicalTrials.gov Identifier: | NCT00273273 |
The purpose of this project is to study the pharmacokinetics of a once-daily antiretroviral medication used to treat adolescents and young adults with HIV infection.
Condition | Intervention | Phase |
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HIV Infections |
Procedure: blood draw |
Phase IV |
Study Type: | Observational |
Study Design: | Natural History, Cross-Sectional, Defined Population, Retrospective/Prospective Study |
Official Title: | Pharmacokinetics of Once Daily Antiretroviral Therapy Regimens Containing Tenofovir and Atazanavir/Ritonavir in Adolescents and Young Adults With HIV Infection |
Estimated Enrollment: | 30 |
Study Start Date: | February 2006 |
Estimated Study Completion Date: | May 2006 |
Once-daily antiretroviral therapy is being used to treat adolescents and young adults with HIV-1 infection. When new antiretrovirals (ARVs) are developed, information on kinetics is collected in adults, and then in children, but often the adolescent age group is under-represented in initial or even later pharmacokinetics studies, so specific data on appropriate drug doses to use in adolescents may be lacking; it is assumed that they should receive the adult dose. Furthermore, as newer drugs are used in combination regimens, more information becomes available on drug interactions that might not have been initially anticipated. This information is usually generated in studies of adults, with little or no specific information in children or adolescents. This is an open-label, 24-hour, single-dose pharmacokinetic study.
Ages Eligible for Study: | 18 Years to 25 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |
University of California at San Diego | |
San Diego, California, United States, 92103 | |
Children's Hospital of Los Angeles | |
Los Angeles, California, United States, 90027 | |
University of California at San Francisco | |
San Francisco, California, United States, 94143 | |
United States, District of Columbia | |
Children's National Medical Center | |
Washington, District of Columbia, United States, 20010 | |
United States, Florida | |
Children's Diagnostic and Treatment Center | |
Fort Lauderdale, Florida, United States, 33316 | |
University of Miami | |
Miami, Florida, United States, 33101 | |
United States, Illinois | |
Stroger Hospital of Cook County | |
Chicago, Illinois, United States, 60612 | |
United States, Maryland | |
University of Maryland | |
Baltimore, Maryland, United States, 21201 | |
United States, Massachusetts | |
Children's Hopsital of Boston | |
Boston, Massachusetts, United States, 02115 | |
United States, New York | |
Mount Sinai Hospital | |
New York, New York, United States, 10128 | |
United States, Pennsylvania | |
Children's Hospital of Philadelphia | |
Philadelphia, Pennsylvania, United States, 19104 | |
Puerto Rico | |
University of Puerto Rico | |
San Juan, Puerto Rico, 00936 |
Study Chair: | Peter Havens, MD | MACC Fund Research Center |
Study ID Numbers: | ATN 056 |
Study First Received: | January 4, 2006 |
Last Updated: | April 2, 2007 |
ClinicalTrials.gov Identifier: | NCT00273273 |
Health Authority: | United States: Federal Government |
HIV Atazanavir ritonavir |
tenofovir Adolescent Treatment Experienced |
Virus Diseases Sexually Transmitted Diseases, Viral Ritonavir HIV Infections Sexually Transmitted Diseases Acquired Immunodeficiency Syndrome |
Tenofovir Atazanavir Retroviridae Infections Immunologic Deficiency Syndromes Tenofovir disoproxil |
Communicable Diseases RNA Virus Infections Slow Virus Diseases |
Immune System Diseases Lentivirus Infections Infection |