Bitherapy With the Combination of Raltegravir and Darunavir (BIRDi) (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

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

Study Overview

• Status: Completed
• Conditions: HIV/AIDS; Comorbidities
• Intervention / Treatment: Other: Collection of data

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 Type: Observational
• Enrollment (Actual): 360

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain, 28034
    • Ramón y Cajal Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

HIV infected patients with virological suppression but toxicity or intolerance to analogues who switched to the combination of Raltegravir plus boosted Darunavir

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Change in cardiovascular risk (by using AHA score) for patients using dual therapy	Changes in lipid parameters will be assessed	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	48 weeks

Collaborators and Investigators

• Sponsor: Asociacion para el Estudio de las Enfermedades Infecciosas
• Collaborators: Merck Sharp & Dohme LLC

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2017
• Primary Completion (Actual): June 15, 2018
• Study Completion (Actual): June 29, 2018

Study Registration Dates

• First Submitted: November 13, 2017
• First Submitted That Met QC Criteria: November 16, 2017
• First Posted (Actual): November 20, 2017

Study Record Updates

• Last Update Posted (Actual): July 2, 2018
• Last Update Submitted That Met QC Criteria: June 29, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Keywords: HIV; Comorbidities; Dual therapy; Nucleoside analogues sparing-regimens
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases; HIV Infections; Acquired Immunodeficiency Syndrome
• Other Study ID Numbers: EC 211/17

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No