PK of Once Daily ART Containing Tenofovir and Atazanavir/Ritonavir

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00273273
Recruitment Status : Completed
First Posted : January 9, 2006
Last Update Posted : February 28, 2017
National Institute on Drug Abuse (NIDA)
National Institute of Mental Health (NIMH)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
HIV Infections Procedure: blood draw

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 Type : Observational
Enrollment : 30 participants
Time Perspective: Other
Official Title: Pharmacokinetics of Once Daily Antiretroviral Therapy Regimens Containing Tenofovir and Atazanavir/Ritonavir in Adolescents and Young Adults With HIV Infection
Study Start Date : February 2006
Actual Primary Completion Date : December 2007
Actual Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Primary Outcome Measures :
  1. Measure the pharmacokinetics of atazanavir/ritonavir and tenofovir [ Time Frame: 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 :
  1. Kinetics comparison [ Time Frame: 6 Months ]
    To compare the kinetics in these study subjects with published kinetics profiles in adults and children.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 25 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Persons with HIV-1 infection between the ages of 18 years, 0 days and 24 years, 364 days currently on a stable combination antiretroviral regimen (> 28 days) with FDA-approved antiretroviral combination regimens that include tenofovir plus atazanavir/ritonavir and at least one other active antiretroviral drug.

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.

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00273273

United States, California
Children's Hospital of Los Angeles
Los Angeles, California, United States, 90027
University of California at San Diego
San Diego, California, United States, 92103
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
Sponsors and Collaborators
University of North Carolina, Chapel Hill
National Institute on Drug Abuse (NIDA)
National Institute of Mental Health (NIMH)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Study Chair: Peter Havens, MD MACC Fund Research Center

Additional Information:
Responsible Party: University of North Carolina, Chapel Hill Identifier: NCT00273273     History of Changes
Other Study ID Numbers: ATN 056
First Posted: January 9, 2006    Key Record Dates
Last Update Posted: February 28, 2017
Last Verified: February 2016

Keywords provided by University of North Carolina, Chapel Hill:
Treatment Experienced

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Atazanavir Sulfate
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors