Clinical trial NCT03348449: Bitherapy With the Combination of Raltegravir and Darunavir (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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Comorbidities
HIV/AIDS
Keywords: HIV
Dual therapy
Comorbidities
Nucleoside analogues sparing-regimens
Lead sponsor: Asociacion para el Estudio de las Enfermedades Infecciosas
Sponsor class: NETWORK
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2017-11-20
Enrollment: 360
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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

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

Eligibility criteria: 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

Primary outcomes:
measure: Percentage of patients who maintained virological suppression on treatment at 48 weeks after using this dual therapy
timeFrame: 48 weeks
Secondary outcomes:
measure: Change in renal parameters at 48 weeks,for patients using dual therapy
timeFrame: 48 weeks
measure: Change in bone parameters (bone mineral density by Dual X-ray absorptiometry) during the study
timeFrame: 48 weeks
measure: Change in cardiovascular risk (by using AHA score) for patients using dual therapy
timeFrame: 48 weeks
measure: Changes in inflammatory markers during the study, measured by the CD4/CD8 ratio
timeFrame: 48 weeks
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Ramon y Cajal Hospital
Study officials:
References: