Bitherapy With the Combination of Raltegravir and Darunavir (BIRDi)

HIV/AIDS Clinical Trial

— BIRDi  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03348449
• Other study ID #: EC 211/17
• Status: Completed
• Start date: December 15, 2017
• Est. completion date: June 29, 2018

Study information

• Verified date: June 2018
• Source: Asociacion para el Estudio de las Enfermedades Infecciosas
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 360
• Est. completion date: June 29, 2018
• Est. primary completion date: June 15, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Comorbidities
• HIV/AIDS

Intervention

Other:
• Collection of data
Outcome of patients will be collected from charts to evaluate primary and secondary objectives

Locations

Country	Name	City	State
Spain	Ramon y Cajal Hospital	Madrid

Sponsors (2)

Lead Sponsor	Collaborator
Asociacion para el Estudio de las Enfermedades Infecciosas	Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Change in cardiovascular risk (by using AHA score) for patients using dual therapy	Changes in lipid parameters will be assessed	48 weeks
Secondary	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