Status:
COMPLETED
Bitherapy With the Combination of Raltegravir and Darunavir (BIRDi)
Lead Sponsor:
Asociacion para el Estudio de las Enfermedades Infecciosas
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
Comorbidities
HIV/AIDS
Eligibility:
All Genders
18+ years
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 toxi...
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 e...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 15 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 29 2018
Estimated Enrollment :
360 Patients enrolled
Trial Details
Trial ID
NCT03348449
Start Date
December 15 2017
End Date
June 29 2018
Last Update
July 2 2018
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Ramon y Cajal Hospital
Madrid, Spain, 28034