HIVNCT01329783
EuroSIDA As An External Comparator To MOTIVATE Trials
An observational study of HIV and AIDS, run by ViiV Healthcare.
Trial summary
Human Immunodeficiency Virus (HIV) infected patients who meet the entry criteria for the maraviroc pivotal trials (Maraviroc versus Optimized Therapy in Viremic Antiretroviral Treatment-Experienced Patients, MOTIVATE) will be identified from the EuroSIDA HIV cohort. Read more about this study
- Who is it for?
- Ages 16 years and older
- What is being tested?
- maraviroc
- How many people
- 1,181 participants
- Where
- No sites listed yet
- Study dates
- Apr 2007to Mar 2011
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: * Patient aged over 16 at baseline. * Viral Load (VL) > 5000 copies/ml at baseline (and measured in 6 months prior to baseline). * No changes in antiretroviral (ARV) regimens in the month period prior to baseline, or on no ARVs in the month prior to baseline. * > 3 months exposure (sequential or cumulative) to at least 3 of the following; * Any nucleoside or nucleotide reverse transcriptase inhibitor (NRTI) * Non-nucleoside reverse transcriptase inhibitor (NNNRTI) * Protease Inhibitor (PI ) * Enfuvirtide
Who may be able to join
- Patient aged over 16 at baseline.
- Viral Load (VL) > 5000 copies/ml at baseline (and measured in 6 months prior to baseline).
- No changes in antiretroviral (ARV) regimens in the month period prior to baseline, or on no ARVs in the month prior to baseline.
- > 3 months exposure (sequential or cumulative) to at least 3 of the following;
- Any nucleoside or nucleotide reverse transcriptase inhibitor (NRTI)
- Non-nucleoside reverse transcriptase inhibitor (NNNRTI)
- Protease Inhibitor (PI )
- Enfuvirtide
Who cannot join
- None
About this study
Official title: Incidence And Risk Factors For Acquired Immune Deficiency Syndrome (AIDS) Defining And Non-AIDS Defining Malignancies, And Other AIDS Defining Illnesses In The EuroSIDA Study
Human Immunodeficiency Virus (HIV) infected patients who meet the entry criteria for the maraviroc pivotal trials (Maraviroc versus Optimized Therapy in Viremic Antiretroviral Treatment-Experienced Patients, MOTIVATE) will be identified from the EuroSIDA HIV cohort. The rates of specific clinical adverse events in this identified patient population will be compared with the rates of these events in the participants of the MOTIVATE trials.
Read the detailed description
All patients in EuroSIDA cohort that meet the entry criteria of MOTIVATE trials are included without any sampling.
- Being tested
- maraviroc
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
maravirocOther
Also called Selzentry, Celsentri
No intervention is distributed during this trial.
| Study group | Role | What they receive |
|---|---|---|
| EuroSIDA sub-cohort | HIV infected patients in the EuroSIDA cohort who meet the entry criteria for maraviroc pivotal clinical trials (MOTIVATE 1 and MOTIVATE 2) Receives: Other: maraviroc |
What is being measured
The primary outcome is the main question the study is designed to answer.
Malignancy
Measured: Median follow up of 3 years
Opportunistic infection
Measured: Median follow up of 3 years
Myocardial infarction
Measured: Median follow up of 3 years
All cause death
Measured: Median follow up of 3 years
Liver related death
Measured: Median follow up of 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2011 (estimated)
- Study startApr 2007
- Primary completionMar 2011
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by ViiV HealthcareThe 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
- Retrospective
- Enrolment
- 1,181 participants (actual)
Sponsor and investigators
- Lead sponsor
- ViiV Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Copenhagen HIV Programme, Pfizer
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01329783
- Sponsor's protocol ID
- A4001104
- Status last verified
- May 2011
- First submitted
- 16 Mar 2011
- Last updated
- 16 May 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence And Risk Factors For Acquired Immune Deficiency Syndrome (AIDS) Defining And Non-AIDS Defining Malignancies, And Other AIDS Defining Illnesses In The EuroSIDA Study
- ClinicalTrials.gov ID
- NCT01329783
- Acronym / sponsor ID
- A4001104
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,181 participants (actual)
- Lead sponsor
- ViiV HealthcareIndustry (pharma, biotech, devices)
- Collaborators
- Copenhagen HIV Programme, Pfizer
- Study start
- Apr 2007
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 6 Apr 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.
Human Immunodeficiency Virus (HIV) infected patients who meet the entry criteria for the maraviroc pivotal trials (Maraviroc versus Optimized Therapy in Viremic Antiretroviral Treatment-Experienced Patients, MOTIVATE) will be identified from the EuroSIDA HIV cohort. The rates of specific clinical adverse events in this identified patient population will be compared with the rates of these events in the participants of the MOTIVATE trials.
Detailed description
All patients in EuroSIDA cohort that meet the entry criteria of MOTIVATE trials are included without any sampling.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EuroSIDA sub-cohort | – | Other: maravirocHIV infected patients in the EuroSIDA cohort who meet the entry criteria for maraviroc pivotal clinical trials (MOTIVATE 1 and MOTIVATE 2) |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- * Patient aged over 16 at baseline. * Viral Load (VL) > 5000 copies/ml at baseline (and measured in 6 months prior to baseline). * No changes in antiretroviral (ARV) regimens in the month period prior to baseline, or on no ARVs in the month prior to baseline. * > 3 months exposure (sequential or cumulative) to at least 3 of the following; * Any nucleoside or nucleotide reverse transcriptase inhibitor (NRTI) * Non-nucleoside reverse transcriptase inhibitor (NNNRTI) * Protease Inhibitor (PI ) * Enfuvirtide
Key inclusion criteria (8 listed)
- Patient aged over 16 at baseline.
- Viral Load (VL) > 5000 copies/ml at baseline (and measured in 6 months prior to baseline).
- No changes in antiretroviral (ARV) regimens in the month period prior to baseline, or on no ARVs in the month prior to baseline.
- > 3 months exposure (sequential or cumulative) to at least 3 of the following;
- Any nucleoside or nucleotide reverse transcriptase inhibitor (NRTI)
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| maravirocAlso: Selzentry, CelsentriNo intervention is distributed during this trial. | Other | EuroSIDA sub-cohort |
Primary outcome
Malignancy
Time frame: Median follow up of 3 years
Opportunistic infection
Time frame: Median follow up of 3 years
Myocardial infarction
Time frame: Median follow up of 3 years
All cause death
Time frame: Median follow up of 3 years
Liver related death
Time frame: Median follow up of 3 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 16 May 2011.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
Related trials for HIV
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.
Pfizer CT.gov Call Center study director
Pfizer
Questions about this trial
What is this clinical trial studying?
An observational study of HIV and AIDS, run by ViiV Healthcare.
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 8 inclusion and 1 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 16 May 2011. Status can change between updates, so confirm with the study contact before making plans.
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?
Malignancy (time frame: Median follow up of 3 years). The study lists 5 primary outcomes in all. 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 16 May 2011.