Post-marketing Safety Surveillance Program in Human Immunodeficiency Virus (HIV)-Infected Children Exposed to Atazanavir in Europe

An observational study of HIV Infection, run by Bristol-Myers Squibb at 9 sites in 7 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The purpose of this study is to monitor adverse events in HIV-infected children <18 years old who are exposed to Atazanavir in a real-world setting in Europe. Read more about this study

Who is it for?: Ages Up to 17 years
Conditions the study is for: HIV Infection
How many people: 249 participants
Where: 9 sitesin 7 countries
Study dates: Jul 2011to Feb 2014
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 Up to 17 years
All sexes
No healthy volunteers
Child

Study population: Primary care clinic

Who may be able to join

HIV-infected children participating in individual prospective paediatric HIV cohorts
Receive Atazanavir treatment during 01JAN2011 to 30DEC2013
Age <18 years old on the date starting an Atazanavir-containing regimen
Have a minimum of 3 months of follow-up

Who cannot join

None listed.

Trial locations and contacts

9 sites in 7 countries.

Country

City, postcode or hospital

9 sites in 7 countries

Spain2 sites

Spanish Perinatal Cohort
Barcelona
Madrid Paediatric HIV Cohort
Madrid

Other trials in Spain

United Kingdom2 sites

Collaborative HIV Paediatric Study
London
European Collaborative Study
London

Other trials in United Kingdom

Belgium1 site

Hospital St Pierre
Brussels

Other trials in Belgium

Germany1 site

German Competence Network
Frankfurt

Other trials in Germany

Italy1 site

Italian Register for HIV-infection in Children
Florence

Other trials in Italy

Romania1 site

Victor Babes Hospital
Bucharest

Other trials in Romania

Switzerland1 site

Swiss Mother and Child HIV Cohort
Basel

Other trials in Switzerland

About this study

Official title: Post-marketing Safety Surveillance Program in HIV-infected Children Exposed to Atazanavir in Europe

The purpose of this study is to monitor adverse events in HIV-infected children <18 years old who are exposed to Atazanavir in a real-world setting in Europe.

Conditions: HIV Infection
Medical subject headings: HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01389310
Study group	Role	What they receive
HIV-infected children <18 yrs old - exposed to Atazanavir		Not described

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Adverse events reported during Atazanavir drug exposure
Timeframe of the study
Measured: 36 months

Secondary outcomes (3)

Pattern of use of Atazanavir
Atazanavir dosage administered, treatment duration (date started, date stopped), reason for dosage adjustment, withdrawal and reason for withdrawal, Ritonavir dose, other antiretroviral drug use, and other concomitant medications
Measured: 12-months
Pattern of use of Atazanavir
Atazanavir dosage administered, treatment duration (date started, date stopped), reason for dosage adjustment, withdrawal and reason for withdrawal, Ritonavir dose, other antiretroviral drug use, and other concomitant medications
Measured: 24-months
Pattern of use of Atazanavir
Atazanavir dosage administered, treatment duration (date started, date stopped), reason for dosage adjustment, withdrawal and reason for withdrawal, Ritonavir dose, other antiretroviral drug use, and other concomitant medications
Measured: 36-months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2011Feb 2014

First posted8 Jul 2011 (estimated)
Study startJul 2011
Primary completionFeb 2014
Study completionFeb 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for HIV InfectionStudies of the same condition, open and under way.
More trials run by Bristol-Myers SquibbThe 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
Observational model: Cohort
Time perspective: Prospective
Enrolment: 249 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01389310
Sponsor's protocol ID: AI424-450
Status last verified: Dec 2014
First submitted: 6 Jul 2011
Last updated: 23 Dec 2014
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Trial Phase: Syndemic Adapted Medly Uganda
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All HIV Infection trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Post-marketing Safety Surveillance Program in HIV-infected Children Exposed to Atazanavir in Europe
ClinicalTrials.gov ID: NCT01389310
Acronym / sponsor ID: AI424-450
Conditions: HIV Infection
Study type: Observational
Recruitment status: Completed
Enrolment: 249 participants (actual)
Lead sponsor: Bristol-Myers SquibbIndustry (pharma, biotech, devices)
Collaborators: PENTA Foundation
Study start: Jul 2011
Primary completion: Feb 2014 (actual)
Study completion: Feb 2014 (actual)
First posted: 8 Jul 2011 (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 study is to monitor adverse events in HIV-infected children <18 years old who are exposed to Atazanavir in a real-world setting in Europe.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
HIV-infected children <18 yrs old - exposed to Atazanavir	–	–

Who may qualify

Ages: Up to 17 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child
Study population: Primary care clinic

Key inclusion criteria (4 listed)

HIV-infected children participating in individual prospective paediatric HIV cohorts
Receive Atazanavir treatment during 01JAN2011 to 30DEC2013
Age <18 years old on the date starting an Atazanavir-containing regimen
Have a minimum of 3 months of follow-up

Key exclusion criteria (0 listed)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Number of Adverse events reported during Atazanavir drug exposure
Time frame: 36 months
Timeframe of the study

3 secondary outcomes

Pattern of use of Atazanavir
Time frame: 12-months
Pattern of use of Atazanavir
Time frame: 24-months
Pattern of use of Atazanavir
Time frame: 36-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 23 Dec 2014.
For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htmLink provided by the sponsor.

Related trials for HIV Infection

Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder

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.

Bristol-Myers Squibb study director

Bristol-Myers Squibb

9 sites in 7 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of HIV Infection, run by Bristol-Myers Squibb at 9 sites in 7 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 4 inclusion and 0 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 23 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in Spain, United Kingdom, Belgium, Germany, Italy and 2 more countries. 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?

Number of Adverse events reported during Atazanavir drug exposure (time frame: 36 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01389310.

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 23 Dec 2014.