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Completed

NCT Number: NCT03348449

Bitherapy With the Combination of Raltegravir and Darunavir (BIRDi)

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

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Key information

Conditions

Comorbidities Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections HIV/AIDS Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ramon y Cajal Hospital

Madrid, 28034, Spain

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Collection of data

Other

Outcome of patients will be collected from charts to evaluate primary and secondary objectives

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Asociacion para el Estudio de las Enfermedades Infecciosas

Network

Collaborators

  • Merck Sharp & Dohme LLC

Registry information

Official study 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

Acronym: BIRDi

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Nov 20, 2017
Registry last updated
Jul 2, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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