Clinical trial · Observational
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| AIDS | — | UNRESOLVED | — |
| HIV | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| maraviroc | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- EuroSIDA sub-cohort
- description
- HIV infected patients in the EuroSIDA cohort who meet the entry criteria for maraviroc pivotal clinical trials (MOTIVATE 1 and MOTIVATE 2)
- interventionNames
- Other: maraviroc
Primary outcomes (5)
- measure
- Malignancy
- timeFrame
- Median follow up of 3 years
- measure
- Opportunistic infection
- timeFrame
- Median follow up of 3 years
- measure
- Myocardial infarction
- timeFrame
- Median follow up of 3 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 16 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available