HIV InfectionsNCT00273273
PK of Once Daily ART Containing Tenofovir and Atazanavir/Ritonavir
An observational study of HIV Infections, run by University of North Carolina, Chapel Hill at 12 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- What is being tested?
- blood draw
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 12 sitesin 2 countries
- Study dates
- Feb 2006to Dec 2007
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- 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.
Show all 16Show fewer
- 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.
Who cannot join
- 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).
Trial locations and contacts
12 sites in 2 countries.
12 sites in 2 countries
United States11 sites
University of Maryland
Baltimore, Maryland, 21201
Children's Hopsital of Boston
Boston, Massachusetts, 02115
Stroger Hospital of Cook County
Chicago, Illinois, 60612
Children's Diagnostic and Treatment Center
Fort Lauderdale, Florida, 33316
Children's Hospital of Los Angeles
Los Angeles, California, 90027
University of Miami
Miami, Florida, 33101
Mount Sinai Hospital
New York, New York, 10128
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
University of California at San Diego
San Diego, California, 92103
University of California at San Francisco
San Francisco, California, 94143
Children's National Medical Center
Washington D.C., District of Columbia, 20010
About this study
Official title: Pharmacokinetics of Once Daily Antiretroviral Therapy Regimens Containing Tenofovir and Atazanavir/Ritonavir in Adolescents and Young Adults With HIV Infection
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.
Read the 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.
- Conditions
- HIV Infections
- Being tested
- blood draw
- Keywords
- HIV, Atazanavir, ritonavir, tenofovir, Adolescent, Treatment Experienced
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood drawProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 Months
Secondary outcomes (1)
Kinetics comparison
To compare the kinetics in these study subjects with published kinetics profiles in adults and children.
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2006 (estimated)
- Study startFeb 2006
- Primary completionDec 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Other
- Enrolment
- 30 participants
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), National Institute of Mental Health (NIMH), National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Sponsor
- Investigators
- Peter Havens, MD, Study chair, MACC Fund Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00273273
- Sponsor's protocol ID
- ATN 056
- Status last verified
- Feb 2016
- First submitted
- 4 Jan 2006
- Last updated
- 28 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics of Once Daily Antiretroviral Therapy Regimens Containing Tenofovir and Atazanavir/Ritonavir in Adolescents and Young Adults With HIV Infection
- ClinicalTrials.gov ID
- NCT00273273
- Acronym / sponsor ID
- ATN 056
- Conditions
- HIV Infections
- Keywords
- HIV, Atazanavir, ritonavir, tenofovir, Adolescent, Treatment Experienced
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), National Institute of Mental Health (NIMH), National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- Feb 2006
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 9 Jan 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Time perspective
- Other
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (16 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood draw | Procedure or surgery | – |
Primary outcome
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
1 secondary outcome
Kinetics comparison
Time frame: 6 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2017.
- Website for the Adolescent Trials Network for HIV/AIDS InterventionsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Havens, MD study chair
MACC Fund Research Center
12 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infections, run by University of North Carolina, Chapel Hill at 12 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure the pharmacokinetics of atazanavir/ritonavir and tenofovir (time frame: 6 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2017.