NCT03348449

Bitherapy With the Combination of Raltegravir and Darunavir (BIRDi)

A Retrospective Cohort Study of the Efficacy and Evolution of Comorbidities With the Combination of Raltegravir and Boosted Darunavir in Suppressed HIV-infected Patients With Intolerance or Toxicity to Nucleoside Analogues

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 360 (actual)
• Sponsor: Asociacion para el Estudio de las Enfermedades Infecciosas · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Retrospective cohort of virologically suppressed HIV-infected patients who received the combination of Raltegravir plus Darunavir boosted with cobicistat or ritonavir, as dual therapy, because or toxicity or intolerance to nucleoside analogues

Detailed description

This is a retrospective cohort study including those HIV-infected patients who received the combination of raltegravir plus darunavir boosted with cobicistat or ritonavir as dual therapy, due to the existence of toxicity or intolerance to nucleoside analogues, to evaluate: * efficacy, measured as percentage of patients free of virological failure after 48 and 96 weeks (ITT-e, snapchot analysis) and improvement in CD4+ count * tolerance (rate of discontinuation and cause, and frequency of adverse events) * evolution of different comorbidities (renal, bone, cardiovascular events) Patients will included if they have received at least 1 dose of the dual therapy

Conditions

• Comorbidities
• HIV/AIDS

Interventions

Type	Name	Description
OTHER	Collection of data	Outcome of patients will be collected from charts to evaluate primary and secondary objectives

Timeline

• Start date: 2017-12-15
• Primary completion: 2018-06-15
• Completion: 2018-06-29
• First posted: 2017-11-20
• Last updated: 2018-07-02

Locations

1 site across 1 country: Spain