Bitherapy With the Combination of Raltegravir and Darunavir (BIRDi)

Study Overview
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Brief Summary
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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
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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

Official Title
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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

Conditions
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Comorbidities, HIV/AIDS

Intervention / Treatment
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* Other: Collection of data


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: HIV infection Older than 18 years To have received the combination of raltegravir plus boosted darunavir in patients with virological suppression (more than 6 months) after toxicity or intolerance to nucleoside analogues Exclusion Criteria: Virological failure in the last 6 months previous to dual therapy Presence or suspicion of resistance to Darunavir (major mutations according to Meyer et al) or to Raltegravir (major mutations according to IAS list) Active hepatitis B

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Collection of data|Outcome of patients will be collected from charts to evaluate primary and secondary objectives|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients who maintained virological suppression on treatment at 48 weeks after using this dual therapy | The number of patients who remained with virological suppression during the study at 48 weeks (ITT-exposed, snapchot analysis) | 48 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in renal parameters at 48 weeks,for patients using dual therapy | Evaluation of renal parameters in patients changing to this dual therapy, considering the previous use of TDF or not. | 48 weeks | 
| Change in bone parameters (bone mineral density by Dual X-ray absorptiometry) during the study | Quantitative changes in bone mineral density (BMD) according to previous use of TDF and renal parameters | 48 weeks | 
| Change in cardiovascular risk (by using AHA score) for patients using dual therapy | Changes in lipid parameters will be assessed | 48 weeks | 
| Changes in inflammatory markers during the study, measured by the CD4/CD8 ratio | Those patients who received this dual therapy will be evaluated to determine changes in inflammatory biomarkers such as CD4/CD8 ratio | 48 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, Dual therapy, Comorbidities, Nucleoside analogues sparing-regimens