Clinical trial NCT00273273: PK of Once Daily ART Containing Tenofovir and Atazanavir/Ritonavir
Official title: Pharmacokinetics of Once Daily Antiretroviral Therapy Regimens Containing Tenofovir and Atazanavir/Ritonavir in Adolescents and Young Adults With HIV Infection
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Infections
Keywords: HIV
Atazanavir
ritonavir
tenofovir
Adolescent
Treatment Experienced
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
name: National Institute of Mental Health (NIMH)
name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2006-01-09
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Time perspective: OTHER
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.

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.

Eligibility 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).

Primary outcomes:
measure: Measure the pharmacokinetics of atazanavir/ritonavir and tenofovir
timeFrame: 6 Months
Secondary outcomes:
measure: Kinetics comparison
timeFrame: 6 Months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Children's Hospital of Los Angeles
state: California
city: San Diego
country: United States
facility: University of California at San Diego
state: California
city: San Francisco
country: United States
facility: University of California at San Francisco
state: California
city: Washington
country: United States
facility: Children's National Medical Center
state: District of Columbia
city: Fort Lauderdale
country: United States
facility: Children's Diagnostic and Treatment Center
state: Florida
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Chicago
country: United States
facility: Stroger Hospital of Cook County
state: Illinois
city: Baltimore
country: United States
facility: University of Maryland
state: Maryland
city: Boston
country: United States
facility: Children's Hopsital of Boston
state: Massachusetts
city: New York
country: United States
facility: Mount Sinai Hospital
state: New York
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
city: San Juan
country: Puerto Rico
facility: University of Puerto Rico
Study officials:
affiliation: MACC Fund Research Center
name: Peter Havens, MD
role: STUDY_CHAIR
References: