PK of Once Daily ART Containing Tenofovir and Atazanavir/Ritonavir

This study has been completed.
Sponsor:
Collaborators:
Information provided by (Responsible Party):
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:
NCT00273273
First received: January 4, 2006
Last updated: May 15, 2014
Last verified: April 2014
  Purpose

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
HIV Infections
Procedure: blood draw
Phase 4

Study Type: Observational
Official Title: Pharmacokinetics of Once Daily Antiretroviral Therapy Regimens Containing Tenofovir and Atazanavir/Ritonavir in Adolescents and Young Adults With HIV Infection

Resource links provided by NLM:


Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

Primary Outcome Measures:
  • 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:
  • Kinetics comparison [ Time Frame: 6 Months ]
    To compare the kinetics in these study subjects with published kinetics profiles in adults and children.


Estimated Enrollment: 30
Study Start Date: February 2006
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years to 25 Years
Genders Eligible for Study:   Both
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.

Criteria

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00273273

Locations
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
Investigators
Study Chair: Peter Havens, MD MACC Fund Research Center
  More Information

Additional Information:
No publications provided

Responsible Party: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier: NCT00273273     History of Changes
Other Study ID Numbers: ATN 056
Study First Received: January 4, 2006
Last Updated: May 15, 2014
Health Authority: United States: Federal Government

Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
HIV
Atazanavir
ritonavir
tenofovir
Adolescent
Treatment Experienced

Additional relevant MeSH terms:
Infection
Communicable Diseases
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
Ritonavir
Atazanavir
Tenofovir
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on September 18, 2014