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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03348449

Acronym

BIRDi

Enrollment

360

Registered

2017-11-20

Start date

2017-12-15

Completion date

2018-06-29

Last updated

2018-07-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Comorbidities, HIV/AIDS

Keywords

HIV, Dual therapy, Comorbidities, Nucleoside analogues sparing-regimens

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

Interventions

OTHERCollection of data

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

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.
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
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

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026