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
1 other identifier
observational
360
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2017
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 13, 2017
CompletedFirst Posted
Study publicly available on registry
November 20, 2017
CompletedStudy Start
First participant enrolled
December 15, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 15, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
June 29, 2018
CompletedJuly 2, 2018
June 1, 2018
6 months
November 13, 2017
June 29, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
Change in renal parameters at 48 weeks,for patients using dual therapy
48 weeks
Change in bone parameters (bone mineral density by Dual X-ray absorptiometry) during the study
48 weeks
Change in cardiovascular risk (by using AHA score) for patients using dual therapy
48 weeks
Changes in inflammatory markers during the study, measured by the CD4/CD8 ratio
48 weeks
Interventions
Outcome of patients will be collected from charts to evaluate primary and secondary objectives
Eligibility Criteria
HIV infected patients with virological suppression but toxicity or intolerance to analogues who switched to the combination of Raltegravir plus boosted Darunavir
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ramon y Cajal Hospital
Madrid, 28034, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- NETWORK
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Physician
Study Record Dates
First Submitted
November 13, 2017
First Posted
November 20, 2017
Study Start
December 15, 2017
Primary Completion
June 15, 2018
Study Completion
June 29, 2018
Last Updated
July 2, 2018
Record last verified: 2018-06
Data Sharing
- IPD Sharing
- Will not share