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Clinical Trials/EUCTR2018-004499-36-ES
EUCTR2018-004499-36-ES
Active, not recruiting
Phase 1

Study to assess bone health with bone mineral density, bone microarchitecture and bone tissue quality after switching from a TDF regimen to Bictegravir-TAF-FTC - Study of the bone after the change to bictegravir-TAF

Consorci Mar Parc de Salut de Barcelona0 sites60 target enrollmentJune 11, 2019
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DrugsBiktarvyAtriplaStribildEVIPLERA

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Not specified
Sponsor
Consorci Mar Parc de Salut de Barcelona
Enrollment
60
Status
Active, not recruiting
Last Updated
6 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
June 11, 2019
End Date
TBD
Last Updated
6 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • •\- Treated Adult patients for HIV, virologically suppressed during a regimen containing TDF for more than 48 weeks, regardless of the BMD values
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1\.2 Adults (18\-64 years) yes
  • •F.1\.2\.1 Number of subjects for this age range 60
  • •F.1\.3 Elderly (\>\=65 years) yes
  • •F.1\.3\.1 Number of subjects for this age range 10

Exclusion Criteria

  • •\-Patients who have been previously exposed to any medication that may affect bone, such as systemic glucocorticoids and anti\-osteoporosis medications.
  • •\- Patients previously diagnosed with conditions that could affect bone: chronic kidney disease (GFR MDRD \<45 ml / min / 1\.73m ^ 2\), chronic untreated endocrine disorders, end\-stage decompensated liver disease or malabsorptive disorders; or other bone diseases such as Paget's bone disease; neoplasia or any condition that, in the opinion of the investigator, may interfere with the study protocol

Outcomes

Primary Outcomes

Not specified

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