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Bitherapy With the Combination of Raltegravir and Darunavir (BIRDi) (BIRDi)

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ClinicalTrials.gov Identifier: NCT03348449
Recruitment Status : Completed
First Posted : November 20, 2017
Last Update Posted : July 2, 2018
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Jose L. Casado, Asociacion para el Estudio de las Enfermedades Infecciosas

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

Condition or disease Intervention/treatment
Comorbidities HIV/AIDS Other: Collection of data

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


Study Type : Observational
Actual Enrollment : 360 participants
Observational Model: Cohort
Time Perspective: Retrospective
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
Actual Study Start Date : December 15, 2017
Actual Primary Completion Date : June 15, 2018
Actual Study Completion Date : June 29, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS


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


Primary Outcome Measures :
  1. Percentage of patients who maintained virological suppression on treatment at 48 weeks after using this dual therapy [ Time Frame: 48 weeks ]
    The number of patients who remained with virological suppression during the study at 48 weeks (ITT-exposed, snapchot analysis)


Secondary Outcome Measures :
  1. Change in renal parameters at 48 weeks,for patients using dual therapy [ Time Frame: 48 weeks ]
    Evaluation of renal parameters in patients changing to this dual therapy, considering the previous use of TDF or not.

  2. Change in bone parameters (bone mineral density by Dual X-ray absorptiometry) during the study [ Time Frame: 48 weeks ]
    Quantitative changes in bone mineral density (BMD) according to previous use of TDF and renal parameters

  3. Change in cardiovascular risk (by using AHA score) for patients using dual therapy [ Time Frame: 48 weeks ]
    Changes in lipid parameters will be assessed

  4. Changes in inflammatory markers during the study, measured by the CD4/CD8 ratio [ Time Frame: 48 weeks ]
    Those patients who received this dual therapy will be evaluated to determine changes in inflammatory biomarkers such as CD4/CD8 ratio



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03348449


Locations
Spain
Ramon y Cajal Hospital
Madrid, Spain, 28034
Sponsors and Collaborators
Asociacion para el Estudio de las Enfermedades Infecciosas
Merck Sharp & Dohme Corp.

Responsible Party: Jose L. Casado, Physician, Asociacion para el Estudio de las Enfermedades Infecciosas
ClinicalTrials.gov Identifier: NCT03348449     History of Changes
Other Study ID Numbers: EC 211/17
First Posted: November 20, 2017    Key Record Dates
Last Update Posted: July 2, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Jose L. Casado, Asociacion para el Estudio de las Enfermedades Infecciosas:
HIV
Dual therapy
Comorbidities
Nucleoside analogues sparing-regimens

Additional relevant MeSH terms:
Raltegravir Potassium
Darunavir
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
HIV Integrase Inhibitors
Integrase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
HIV Protease Inhibitors
Protease Inhibitors