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EuroSIDA As An External Comparator To MOTIVATE Trials

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01329783
Enrollment
1181
Registered
2011-04-06
Start date
2007-04-30
Completion date
2011-03-31
Last updated
2011-05-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

AIDS, HIV

Brief 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. 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.

Interventions

OTHERmaraviroc

No intervention is distributed during this trial.

Sponsors

Copenhagen HIV Programme
CollaboratorOTHER_GOV
Pfizer
CollaboratorINDUSTRY
ViiV Healthcare
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

None

Design outcomes

Primary

MeasureTime frame
MalignancyMedian follow up of 3 years
Opportunistic infectionMedian follow up of 3 years
Myocardial infarctionMedian follow up of 3 years
All cause deathMedian follow up of 3 years
Liver related deathMedian follow up of 3 years

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026