Status:
COMPLETED
PK of Once Daily ART Containing Tenofovir and Atazanavir/Ritonavir
Lead Sponsor:
University of North Carolina, Chapel Hill
Collaborating Sponsors:
National Institute on Drug Abuse (NIDA)
National Institute of Mental Health (NIMH)
Conditions:
HIV Infections
Eligibility:
All Genders
18-25 years
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 adult...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
February 1 2006
Trial Type :
OBSERVATIONAL
End Date :
December 1 2007
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00273273
Start Date
February 1 2006
End Date
December 1 2007
Last Update
February 28 2017
Active Locations (12)
Enter a location and click search to find clinical trials sorted by distance.
1
Children's Hospital of Los Angeles
Los Angeles, California, United States, 90027
2
University of California at San Diego
San Diego, California, United States, 92103
3
University of California at San Francisco
San Francisco, California, United States, 94143
4
Children's National Medical Center
Washington D.C., District of Columbia, United States, 20010