PK of Once Daily ART Containing Tenofovir and Atazanavir/Ritonavir

HIV Infections Clinical Trial

Official title:

Pharmacokinetics of Once Daily Antiretroviral Therapy Regimens Containing Tenofovir and Atazanavir/Ritonavir in Adolescents and Young Adults With HIV Infection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00273273
• Other study ID #: ATN 056
• Status: Completed
• Phase: N/A
• First received: January 4, 2006
• Last updated: February 27, 2017
• Start date: February 2006
• Est. completion date: December 2007

Study information

• Verified date: February 2016
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2007
• Est. primary completion date: December 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 25 Years

Eligibility

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).

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• Infection

Intervention

Procedure:
• blood draw

Locations

Country	Name	City	State
Puerto Rico	University of Puerto Rico	San Juan
United States	University of Maryland	Baltimore	Maryland
United States	Children's Hopsital of Boston	Boston	Massachusetts
United States	Stroger Hospital of Cook County	Chicago	Illinois
United States	Children's Diagnostic and Treatment Center	Fort Lauderdale	Florida
United States	Children's Hospital of Los Angeles	Los Angeles	California
United States	University of Miami	Miami	Florida
United States	Mount Sinai Hospital	New York	New York
United States	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania
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	District of Columbia

Sponsors (4)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	National Institute of Mental Health (NIMH), National Institute on Alcohol Abuse and Alcoholism (NIAAA), National Institute on Drug Abuse (NIDA)

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Kinetics comparison	To compare the kinetics in these study subjects with published kinetics profiles in adults and children.	6 Months

External Links

•   Website for the Adolescent Trials Network for HIV/AIDS Interventions