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Clinical Trials/EUCTR2019-000199-41-ES
EUCTR2019-000199-41-ES
Active, Not Recruiting
Phase 1

A phase IV, multicenter, open and randomized study to evaluate the impact of the change of antiretroviral treatment from dual therapy to triple therapy on inflammation in patients with type 1 HIV infection. - INSTINCT

Fundación SEIMC-GESIDA0 sites234 target enrollmentJune 11, 2019
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DrugsBictarvyTivicayEpivir

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Not specified
Sponsor
Fundación SEIMC-GESIDA
Enrollment
234
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

Investigators

Sponsor
Fundación SEIMC-GESIDA

Eligibility Criteria

Inclusion Criteria

  • •\- Men and women \= 18 years
  • •\- Confirmed and documented diagnosis of HIV\-1 infection
  • •\- Virological suppression of more than 48 weeks (confirmed with HIV RNA \<50 copies / ml). The determination of the QoL of a routine routine analysis of \= 12 weeks prior to the signing of the consent is allowed.
  • •\- ART in stable dual therapy (\> 48 weeks) with DTG \+ 3TC
  • •\- Signed informed consent
  • •\- Negative pregnancy test (only women of childbearing age). A woman of childbearing age is considered to be a woman who has not undergone permanent infertility procedures or who has been amenorrheic for less than 12 months.
  • •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 234

Exclusion Criteria

  • •\- Impossibility of obtaining written informed consent to participate in the study
  • •\- Pregnant or lactating women or those who intend to become pregnant during the study period and do not commit to using proven contraceptive methods
  • •\- Any suspicion or confirmation of resistance to TAF, FTC, DTG or BIC.
  • •\- Patients with known hypersensitivity to any excipient used with TAF, 3TC, FTC, DTG or BIC
  • •\- Any autoimmune or chronic inflammatory disease
  • •\- Use of immunomodulatory or immunosuppressive agents, including steroids
  • •\- Chronic treatment with aspirin, statins and other anti\-inflammatory agents
  • •\- Any acute infection in the last 2 months
  • •\- Estimated glomerular filtration rate (eGFR) \<30 mg / ml / m2 measured by any of the available formulas. The determination of the eGFR of a routine preliminary analysis of \= 12 weeks prior to the signing of the consent is allowed
  • •\- Contraindication for the use of TAF

Outcomes

Primary Outcomes

Not specified

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