HIVREMAINNCT01236235
Study on Long Term Outcomes of Atazanavir in Antiretroviral-naïve Human Immunodeficiency Virus (HIV) Patients in Real Life Setting
An observational study of HIV, run by Bristol-Myers Squibb at 53 sites in 3 countries.
Trial summary
The purpose of this study is to describe long term (> 96 weeks) efficacy and safety of Atazanavir-based regimens in real life setting. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV
- How many people
- 525 participants
- Where
- 53 sitesin 3 countries
- Study dates
- Jan 2011to Jul 2013
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients attending HIV specialized management centers will be considered.
Who may be able to join
- Male or Female HIV patients ≥ 18 years old at ATV/RTV initiation treatment date
- Outpatient seen in routine consultation whatever the reason, between January 1st 2011 and March 31st 2012
- Commencing an ATV/RTV-based regimen including at least 2 nucleoside reverse transcriptase inhibitors (NRTI) after February 1st 2008 and before July 31st 2010, regardless of the current ARV treatment ongoing at enrollment visit
Who cannot join
- Patient exposed to or who began ATV/RTV prior to February 1st 2008, or after July 31st 2010 or without a known start date for ATV/RTV therapy
- Exposure to more than 4 weeks of any ARV prior to initiation of ATV/RTV treatment
- Participation in a clinical trial with ATV at the time of or after initiation of ATV/RTV-based regimen
Trial locations and contacts
53 sites in 3 countries.
53 sites in 3 countries
Spain24 sites
Local Institution
Alcorcón, 28922
Local Institution
Badalona, 08916
Local Institution
Barcelona, 08003
Local Institution
Barcelona, 08035
Local Institution
Barcelona, 08041
Local Institution
Granada, 18014
Local Institution
Granollers, 08402
Local Institution
Guadalajara, 19002
Local Institution
Jerez de la Frontera, 11407
Local Institution
Leganés, 28911
Local Institution
Logroño, 26006
Local Institution
Madrid, 28006
Local Institution
Madrid, 28034
Local Institution
Málaga, 29010
Local Institution
Marbella, 29603
Local Institution
Mataró, 08304
Local Institution
Móstoles, 28935
Local Institution
Santiago de Compostela, 15706
Local Institution
Seville, 41013
Local Institution
Tarragona, 43003
Local Institution
Valencia, 46014
Local Institution
Valencia, 46015
Local Institution
Valencia, 46026
Local Institution
Zaragoza, 50009
Germany16 sites
Local Institution
Aachen, 52062
Local Institution
Berlin, 10243
Local Institution
Berlin, 10551
Local Institution
Berlin, 10777
Local Institution
Berlin, 13347
Local Institution
Berlin, 13353
Local Institution
Berlin, 14057
Local Institution
Düsseldorf, 40237
Local Institution
Freiburg im Breisgau, 79106
Local Institution
Hamburg, 20099
Local Institution
Hamburg, 20146
Local Institution
Hanover, 30159
Local Institution
Mannheim, 68161
Local Institution
München, 80801
Local Institution
Regensburg, 93053
Local Institution
Stuttgart, 70197
Portugal13 sites
Local Institution
Aveiro, 3814501
Local Institution
Barreiro, 2830094
Local Institution
Lisbon, 1150199
Local Institution
Lisbon, 1169050
Local Institution
Lisbon, 1349019
Local Institution
Lisbon, 1649028
Local Institution
Portimão, 8500338
Local Institution
Porto, 4099001
Local Institution
Porto, 4369004
Local Institution
Pragal, 2801951
Local Institution
Santarém, 2005177
Local Institution
São Martinho do Bispo, 3041801
Local Institution
Vila Nova de Gaia, 4434502
About this study
Official title: A Non Comparative Observational Study to Describe the Duration and Outcome of Treatment in Therapy naïve HIV Positive Patients Initiated on Atazanavir (ATV)/ Ritonavir (RTV)-Based Highly Active Antiretroviral Therapy (HAART) Regimens
The purpose of this study is to describe long term (> 96 weeks) efficacy and safety of Atazanavir-based regimens in real life setting.
Read the detailed description
Time perspective: Collection of historical data and longitudinal follow up. Patients will be enrolled in 2011/2012 but data will be collected from medical charts from ATV initiation date (Feb 2008 - July 2010) until July 2013 at the latest (if no ATV discontinuation, or death, or lost to follow up).
Non probability sample:
- Specialized HIV management centers will be contacted in order to recruit about 15-20 sites per country.
- Each site will have to enroll an average of 8-12 consecutive patients (min:5; max:30) fulfilling the inclusion/exclusion criteria.
- Conditions
- HIV
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| ARV-naïve HIV patients initiated on ATV/RTV-based therapy | Anti-retroviral (ARV)-naïve HIV patients initiated on ATV/RTV-based therapy between 2008-2010 One cohort being observed for 3 different countries |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients remaining on ATV-based treatment over time
Every 6 months from ATV initiation till July 2013 at the latest (maximum follow-up time up to 5.5 years)
Measured: Up to 5.5 years
Secondary outcomes (8)
Time to discontinuation of ATV
Measured: Every 6 months up to 5.5 years
Reasons for ATV discontinuation
Measured: Every 6 months up to 5.5 years
Percent of patients with HIV-1 ribonucleic acid (RNA) < 50 and < 500 c/mL
Measured: Every 6 months up to 5.5 years
Mean change in HIV-1 RNA
Measured: Every 6 months up to 5.5 years
Time to viral failure (HIV-1 RNA ≥ 50 and ≥ 500 c/mL)
Measured: Every 6 months up to 5.5 years
Mean change in Cluster of differentiation 4 (CD4) cell count
Measured: Every 6 months up to 5.5 years
Adverse events (AEs) related to ATV
Measured: Every 6 months up to 5.5 years
Lipid profile
Measured: Every 6 months up to 5.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2010 (estimated)
- Study startJan 2011
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIVStudies 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
- Enrolment
- 525 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- PharmaNet
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01236235
- Sponsor's protocol ID
- AI424-401
- Acronym
- REMAIN
- Status last verified
- Sep 2013
- First submitted
- 5 Nov 2010
- Last updated
- 5 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Teofilo E, Rocha-Pereira N, Kuhlmann B, Antela A, Knechten H, Santos J, Jimenez-Exposito MJ; REMAIN study group. Long-Term Efficacy, Tolerability, and Renal Safety of Atazanavir/Ritonavir-based Antiretroviral Therapy in a Cohort of Treatment-Naive Patients with HIV-1 Infection: the REMAIN Study. HIV Clin Trials. 2016 Feb;17(1):17-28. doi: 10.1080/15284336.2015.1112494.
PubMed 26899539
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Non Comparative Observational Study to Describe the Duration and Outcome of Treatment in Therapy naïve HIV Positive Patients Initiated on Atazanavir (ATV)/ Ritonavir (RTV)-Based Highly Active Antiretroviral Therapy (HAART) Regimens
- ClinicalTrials.gov ID
- NCT01236235
- Acronym / sponsor ID
- REMAIN / AI424-401
- Conditions
- HIV
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 525 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Collaborators
- PharmaNet
- Study start
- Jan 2011
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 8 Nov 2010 (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 describe long term (> 96 weeks) efficacy and safety of Atazanavir-based regimens in real life setting.
Detailed description
Time perspective: Collection of historical data and longitudinal follow up. Patients will be enrolled in 2011/2012 but data will be collected from medical charts from ATV initiation date (Feb 2008 - July 2010) until July 2013 at the latest (if no ATV discontinuation, or death, or lost to follow up).
Non probability sample:
- Specialized HIV management centers will be contacted in order to recruit about 15-20 sites per country.
- Each site will have to enroll an average of 8-12 consecutive patients (min:5; max:30) fulfilling the inclusion/exclusion criteria.
Study design
- Observational model
- Cohort
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ARV-naïve HIV patients initiated on ATV/RTV-based therapy | – | –Anti-retroviral (ARV)-naïve HIV patients initiated on ATV/RTV-based therapy between 2008-2010 One cohort being observed for 3 different countries |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients attending HIV specialized management centers will be considered.
Key inclusion criteria (3 listed)
- Male or Female HIV patients ≥ 18 years old at ATV/RTV initiation treatment date
- Outpatient seen in routine consultation whatever the reason, between January 1st 2011 and March 31st 2012
- Commencing an ATV/RTV-based regimen including at least 2 nucleoside reverse transcriptase inhibitors (NRTI) after February 1st 2008 and before July 31st 2010, regardless of the current ARV treatment ongoing at enrollment visit
Key exclusion criteria (3 listed)
- Patient exposed to or who began ATV/RTV prior to February 1st 2008, or after July 31st 2010 or without a known start date for ATV/RTV therapy
- Exposure to more than 4 weeks of any ARV prior to initiation of ATV/RTV treatment
- Participation in a clinical trial with ATV at the time of or after initiation of ATV/RTV-based regimen
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
Proportion of patients remaining on ATV-based treatment over time
Time frame: Up to 5.5 years
Every 6 months from ATV initiation till July 2013 at the latest (maximum follow-up time up to 5.5 years)
8 secondary outcomes
Time to discontinuation of ATV
Time frame: Every 6 months up to 5.5 years
Reasons for ATV discontinuation
Time frame: Every 6 months up to 5.5 years
Percent of patients with HIV-1 ribonucleic acid (RNA) < 50 and < 500 c/mL
Time frame: Every 6 months up to 5.5 years
Mean change in HIV-1 RNA
Time frame: Every 6 months up to 5.5 years
Time to viral failure (HIV-1 RNA ≥ 50 and ≥ 500 c/mL)
Time frame: Every 6 months up to 5.5 years
Mean change in Cluster of differentiation 4 (CD4) cell count
Time frame: Every 6 months up to 5.5 years
Adverse events (AEs) related to ATV
Time frame: Every 6 months up to 5.5 years
Lipid profile
Time frame: Every 6 months up to 5.5 years
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 5 Sep 2013.
- Derived from this study: PubMed 26899539Teofilo E, Rocha-Pereira N, Kuhlmann B, Antela A, Knechten H, Santos J, Jimenez-Exposito MJ; REMAIN study group. Long-Term Efficacy, Tolerability, and Renal Safety of Atazanavir/Ritonavir-based Antiretroviral Therapy in a Cohort of Treatment-Naive Patients with HIV-1 Infection: the REMAIN Study. HIV Clin Trials. 2016 Feb;17(1):17-28. doi: 10.1080/15284336.2015.1112494.
- For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htmLink 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.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
53 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV, run by Bristol-Myers Squibb at 53 sites in 3 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 3 inclusion and 3 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 5 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 53 sites in Spain, Germany, Portugal. 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?
Proportion of patients remaining on ATV-based treatment over time (time frame: Up to 5.5 years). 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 NCT01236235, which also lists 1 linked publication.
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 5 Sep 2013.