Bitherapy With the Combination of Raltegravir and Darunavir (BIRDi)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

360 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-12-15

Study Completion Date

2018-06-29

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

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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

Conditions

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Comorbidities HIV/AIDS

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

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Collection of data

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

Intervention Type OTHER

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No