Bitherapy With the Combination of Raltegravir and Darunavir (BIRDi)

Asociacion para el Estudio de las Enfermedades Infecciosas360 enrolled

Overview

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

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

Study Type

OBSERVATIONAL

Enrollment

360

Conditions

Comorbidities HIV/AIDS

Interventions

Collection of dataOTHER

Outcome of patients will be collected from charts to evaluate primary and secondary objectives

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Ramon y Cajal Hospital

Madrid, Spain

Outcomes

Primary Outcomes

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)

Time frame: 48 weeks

Secondary Outcomes

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.

Time frame: 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

Time frame: 48 weeks

Change in cardiovascular risk (by using AHA score) for patients using dual therapy

Changes in lipid parameters will be assessed

Time frame: 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

Time frame: 48 weeks

Data from ClinicalTrials.gov

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