Bitherapy With the Combination of Raltegravir and Darunavir (BIRDi)

Completed

• Conditions: HIV/AIDS; Comorbidities

• Registration Number: NCT03348449
• Lead Sponsor: Asociacion para el Estudio de las Enfermedades Infecciosas

Brief 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

Study Timeline

• Study First Submitted: 2017-11-13
• Study First Submitted QC: 2017-11-16
• Study First Posted: 2017-11-20
• Study Start: 2017-12-15
• Status Verified: 2018-06
• Primary Completion: 2018-06-15
• Study Completion: 2018-06-29
• Last Update Submitted: 2018-06-29
• Last Update Posted: 2018-07-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 360

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Ramon y Cajal Hospital; 🇪🇸 Madrid, Spain