PK of Once Daily ART Containing Tenofovir and Atazanavir/Ritonavir

Completed

• Conditions: HIV Infections

• Registration Number: NCT00273273
• Lead Sponsor: University of North Carolina, Chapel Hill

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2006-01-04
• Study First Submitted QC: 2006-01-05
• Study First Posted: 2006-01-09
• Study Start: 2006-02
• Primary Completion: 2007-12
• Study Completion: 2007-12
• Status Verified: 2016-02
• Last Update Submitted: 2017-02-27
• Last Update Posted: 2017-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Age > 18 year to < 25 years.
• 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.

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Exclusion Criteria

• Pregnancy.
• 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).

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Measure the pharmacokinetics of atazanavir/ritonavir and tenofovir	6 Months	To measure the pharmacokinetics of atazanavir/ritonavir and tenofovir when used in combination to treat HIV-infected adolescents and young adult subjects

Secondary Outcome Measures

Name	Time	Method
Kinetics comparison	6 Months	To compare the kinetics in these study subjects with published kinetics profiles in adults and children.

Trial Locations

Locations (12)

Children's Hospital of Los Angeles; 🇺🇸 Los Angeles, California, United States

Children's Diagnostic and Treatment Center; 🇺🇸 Fort Lauderdale, Florida, United States

Children's Hospital of Philadelphia; 🇺🇸 Philadelphia, Pennsylvania, United States

University of California at San Diego; 🇺🇸 San Diego, California, 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

University of California at San Francisco; 🇺🇸 San Francisco, California, United States

Children's National Medical Center; 🇺🇸 Washington, District of Columbia, United States

University of Puerto Rico; 🇵🇷 San Juan, Puerto Rico