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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03348449
Other study ID # EC 211/17
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 15, 2017
Est. completion date June 29, 2018

Study information

Verified date June 2018
Source Asociacion para el Estudio de las Enfermedades Infecciosas
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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


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


Recruitment information / eligibility

Status Completed
Enrollment 360
Est. completion date June 29, 2018
Est. primary completion date June 15, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Collection of data
Outcome of patients will be collected from charts to evaluate primary and secondary objectives

Locations

Country Name City State
Spain Ramon y Cajal Hospital Madrid

Sponsors (2)

Lead Sponsor Collaborator
Asociacion para el Estudio de las Enfermedades Infecciosas Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
Secondary Change in cardiovascular risk (by using AHA score) for patients using dual therapy Changes in lipid parameters will be assessed 48 weeks
Secondary 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
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