PK of Once Daily ART Containing Tenofovir and Atazanavir/Ritonavir
NCT ID: NCT00273273
Last Updated: 2017-02-28
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
30 participants
OBSERVATIONAL
2006-02-28
2007-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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OTHER
Interventions
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blood draw
Eligibility Criteria
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Inclusion Criteria
* Confirmed diagnosis of HIV-1 infection defined as one positive assay supported by documentation from the subject's medical record. The result may be any of the following:
* HIV-1 DNA PCR,
* HIV-1 RNA PCR (\> 5,000 copies/ml),
* Standard ELISA with confirmatory western blot performed after 18 months of age, or
* HIV culture.
* CD4 cell count: no restrictions.
* Viral load: no restrictions.
* Current treatment with stable antiretroviral combination therapy with at least 3 active drugs for a minimum of 28 days. The treatment regimen will not be started or changed for the purposes of participation in this study. Rather, this study will measure kinetics of the drugs in patients who have been receiving therapy at the direction of their treating physician.
* Regimen must be prescribed at FDA-approved doses for age.
* Regimens allowed:
* Atazanavir 300 mg po once daily plus ritonavir 100 mg po once daily, and
* Tenofovir 300 mg po once daily, plus
* At least one other antiretroviral medication prescribed at FDA-approved dose for age, excluding other protease inhibitors and NNRTIs.
* Ability and willingness to be contacted by study personnel daily for the two days prior to the pharmacokinetics visit, to take antiretroviral medicines at the same time in the morning daily for at least 3 days (one of those days being the day of the PK study visit), and ability and willingness to return to the clinic the day after the observed administered dose for a follow-up measurement of plasma drug concentration.
* Ability and willingness to provide written informed consent.
Exclusion Criteria
* Active therapy for malignancy.
* Known presence of gastrointestinal disease that would interfere with drug administration or absorption.
* Grade 3 or higher ALT or AST.
* Grade 3 or higher Creatinine.
* Concurrent treatment with another protease inhibitor or a non-nucleoside analogue reverse transcriptase inhibitor.
* No evidence of anemia greater than Grade 1 according to the ATN Toxicity Table for Grading Severity of Adolescent Adverse Experiences (see Chapter 11 of ATN MOGO).
18 Years
25 Years
ALL
Yes
Sponsors
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National Institute on Drug Abuse (NIDA)
NIH
National Institute of Mental Health (NIMH)
NIH
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
NIH
University of North Carolina, Chapel Hill
OTHER
Responsible Party
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Principal Investigators
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Peter Havens, MD
Role: STUDY_CHAIR
MACC Fund Research Center
Locations
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Children's Hospital of Los Angeles
Los Angeles, California, United States
University of California at San Diego
San Diego, California, United States
University of California at San Francisco
San Francisco, California, United States
Children's National Medical Center
Washington D.C., District of Columbia, United States
Children's Diagnostic and Treatment Center
Fort Lauderdale, Florida, United States
University of Miami
Miami, Florida, United States
Stroger Hospital of Cook County
Chicago, Illinois, United States
University of Maryland
Baltimore, Maryland, United States
Children's Hopsital of Boston
Boston, Massachusetts, United States
Mount Sinai Hospital
New York, New York, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
University of Puerto Rico
San Juan, , Puerto Rico
Countries
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Related Links
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Website for the Adolescent Trials Network for HIV/AIDS Interventions
Other Identifiers
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ATN 056
Identifier Type: -
Identifier Source: org_study_id
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