PK of Once Daily ART Containing Tenofovir and Atazanavir/Ritonavir
Pharmacokinetics of Once Daily Antiretroviral Therapy Regimens Containing Tenofovir and Atazanavir/Ritonavir in Adolescents and Young Adults With HIV Infection
1 other identifier
observational
30
2 countries
12
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Feb 2006
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 4, 2006
CompletedFirst Posted
Study publicly available on registry
January 9, 2006
CompletedStudy Start
First participant enrolled
February 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2007
CompletedFebruary 28, 2017
February 1, 2016
1.8 years
January 4, 2006
February 27, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Measure the pharmacokinetics of atazanavir/ritonavir and tenofovir
To measure the pharmacokinetics of atazanavir/ritonavir and tenofovir when used in combination to treat HIV-infected adolescents and young adult subjects
6 Months
Secondary Outcomes (1)
Kinetics comparison
6 Months
Interventions
Eligibility Criteria
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.
You may qualify if:
- 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.
- +1 more criteria
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (12)
Children's Hospital of Los Angeles
Los Angeles, California, 90027, United States
University of California at San Diego
San Diego, California, 92103, United States
University of California at San Francisco
San Francisco, California, 94143, United States
Children's National Medical Center
Washington D.C., District of Columbia, 20010, United States
Children's Diagnostic and Treatment Center
Fort Lauderdale, Florida, 33316, United States
University of Miami
Miami, Florida, 33101, United States
Stroger Hospital of Cook County
Chicago, Illinois, 60612, United States
University of Maryland
Baltimore, Maryland, 21201, United States
Children's Hopsital of Boston
Boston, Massachusetts, 02115, United States
Mount Sinai Hospital
New York, New York, 10128, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
University of Puerto Rico
San Juan, 00936, Puerto Rico
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Peter Havens, MD
MACC Fund Research Center
Study Design
- Study Type
- observational
- Time Perspective
- OTHER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 4, 2006
First Posted
January 9, 2006
Study Start
February 1, 2006
Primary Completion
December 1, 2007
Study Completion
December 1, 2007
Last Updated
February 28, 2017
Record last verified: 2016-02