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NCT04076423CompletedPhase 4

A Phase IV Study to Assess the Impact of the Change of Antiretroviral Treatment From Dual Therapy to Triple Therapy on Inflammation in Patients With HIV Infection

A Phase IV, Multicenter, Open and Randomized Study to Assess the Impact of the Change From Antiretroviral Treatment From Dual Therapy to Triple Therapy on Inflammation in Patients With Type 1 HIV Infection. InSTINCT Study

Source: ClinicalTrials.gov · Last updated 1 Oct 2024

Brief summary (registry, in English)

242 patients (121 patients in each of the two treatment arms) will be included with a confirmed diagnosis of HIV-1 infection and with a stable antiretroviral treatment during more than 48 weeks with dual therapy (DTG + 3TC)

Status (registry)
Completed
Phase (registry)
Phase 4
Study type
Interventional
Enrollment
141 (actual)
First submitted
27 Aug 2019
Start date
10 Oct 2019
Primary completion date
15 Jun 2023
Lead sponsor
Fundacion SEIMC-GESIDA
Diseases
HIV
NCT number
NCT04076423

What you commit to

  • Study type: Interventional · Phase 4
  • Participants enrolled: 141
  • From 10 Oct 2019 to the primary completion date, 15 Jun 2023
  • 18 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Any suspicion or confirmation of resistance to TAF, 3TC, FTC, DTG or BIC. In case of have a study of baseline resistance mutations prior to the start of ART has to rule out resistance to investigational drugs.
  • Use of immunomodulatory or immunosuppressive agents, including steroids Chronic treatment with aspirin, statins and other anti-inflammatory agents
  • Estimated glomerular filtration rate (TFGe) \<30 mg / ml / m2 measured by any of the formulas available. The determination of the TFGe of a previous routine analysis of ≤ 12 weeks prior to signing the consent is allowed
  • Simultaneous participation in another clinical trial or research study that requires the need of treatment with other drugs outside the study or interfere with the visits of the same.

Other illness

  • Patients with hypersensitivity to any excipient used with TAF, FTC, DTG or BIC
  • Any chronic autoimmune or inflammatory disease
  • Any acute infection in the last 2 months
  • Clinical condition of the patient in rapid deterioration or the investigator considers that there is no reasonable hope that the patient will finish the study

Other

  • Inability to obtain written informed consent to participate in the study
  • Pregnant or breastfeeding women or those who intend to become pregnant during the study period and do not undertake to use proven contraceptive methods.
  • Contraindication for the use of TAF
  • Any situation that, in the opinion of the investigator, may interfere with the patient's ability to meet the treatment schedule and protocol evaluations

Who the study is looking for

  • 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 CV of a routine prior analysis of ≤ 12 weeks prior to signature of consent.
  • ART in stable dual therapy (\> 48 weeks) with DTG + 3TC
  • Signed informed consent
  • Negative pregnancy test in urine or blood

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (18)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Hospital Universitario Principe de Asturias
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Alcalá de HenaresSpainUnknown status
Hospital De Bellvitge
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BarcelonaSpainUnknown status
Hospital Univ. Vall D'Hebron
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BarcelonaSpainUnknown status
H. General Universitario Guadalajara
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GuadalajaraSpainUnknown status
Hospital San Pedro
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LogroñoSpainUnknown status
Hospital Univ. Ramón y Cajal
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MadridSpainUnknown status
Hospital Universitario Infanta Leonor
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MadridSpainUnknown status
Hospital Clínico San Carlos
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MadridSpainUnknown status
Hospital Fundación Jimenez Diaz
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MadridSpainUnknown status
Hospital Univ La Paz
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MadridSpainUnknown status
Hospital Universitario Puerta de Hierro
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MajadahondaSpainUnknown status
Hospital Virgen de las Nieves
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MaláSpainUnknown status
Hospital Virgen de la Victoria
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MálagaSpainUnknown status
H. General Universitario Reina Sofía
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MurciaSpainUnknown status
Hospital Univ. Virgen del Rocío
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SevilleSpainUnknown status
H. Universitario y Politécnico La Fe
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ValenciaSpainUnknown status
Hospital Univ. Clínico de Valencia
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ValenciaSpainUnknown status
Hospital Univ. Lozano Blesa
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ZaragozaSpainUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.