Bitherapy With the Combination of Raltegravir and Darunavir (BIRDi)

Asociacion para el Estudio de las Enfermedades Infecciosas

Status: Completed

Conditions: Comorbidities; HIV/AIDS

Treatments: Other: Collection of data

Study type: Observational

Funder types: NETWORK; Industry

Identifiers

NCT03348449

EC 211/17

Details and patient eligibility

About

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

Full 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

Enrollment: 360 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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