HIV/AIDS Clinical Trial
— BIRDiOfficial 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
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 |
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 |
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
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 |
Country | Name | City | State |
---|---|---|---|
Spain | Ramon y Cajal Hospital | Madrid |
Lead Sponsor | Collaborator |
---|---|
Asociacion para el Estudio de las Enfermedades Infecciosas | Merck Sharp & Dohme Corp. |
Spain,
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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