Clinical trial NCT04076423: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: HIV Infections
Lead sponsor: Fundacion SEIMC-GESIDA
Sponsor class: OTHER
First posted: 2019-09-03
Enrollment: 141
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Comparator: the patient will continue taking the dual therapy. Experimental: the patient Will beging to take triple therapy.
Primary purpose: TREATMENT

Brief summary: 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)


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 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

Exclusion Criteria:

* 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.
* 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.
* Patients with hypersensitivity to any excipient used with TAF, FTC, DTG or BIC
* Any chronic autoimmune or 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 (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
* Contraindication for the use of TAF
* 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
* 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.
* Any situation that, in the opinion of the investigator, may interfere with the patient's ability to meet the treatment schedule and protocol evaluations

Primary outcomes:
measure: sCD14
timeFrame: Screening, basal, week 23, week 24, week 47, week 48, week 95 y week 96
Secondary outcomes:
measure: Changes in PCR-us
timeFrame: Screening, basal, week 23, week 24, week 47, week 48, week 95 y week 96
measure: Changes in sCD163
timeFrame: Screening, basal, week 23, week 24, week 47, week 48, week 95 y week 96
measure: Changes in quinurenine / tryptophan ratio
timeFrame: Screening, basal, week 23, week 24, week 47, week 48, week 95 y week 96
measure: Changes in Dimer D
timeFrame: Screening, basal, week 23, week 24, week 47, week 48, week 95 y week 96
measure: Changes in CD4/CD8 ratio
timeFrame: Screening, basal, week 23, week 24, week 47, week 48, week 95 y week 96
measure: Changes in CD4+
timeFrame: Throughout all the study, an average of 100 weeks
measure: Changes in viral suppression rates
timeFrame: Throughout all the study, an average of 100 weeks
measure: Longitudinal trajectories of plasma biomarkers
timeFrame: Throughout all the study, an average of 100 weeks
measure: Longitudinal trajectories of CD4/CD8 ratio
timeFrame: Throughout all the study, an average of 100 weeks
Other outcomes:
Locations:
city: Logroño
country: Spain
facility: Hospital San Pedro
state: La Rioja
city: Alcalá De Henares
country: Spain
facility: Hospital Universitario Príncipe de Asturias
state: Madrid
city: Majadahonda
country: Spain
facility: Hospital Universitario Puerta de Hierro
state: Madrid
city: Barcelona
country: Spain
facility: Hospital de Bellvitge
city: Barcelona
country: Spain
facility: Hospital Univ. Vall D'Hebron
city: Guadalajara
country: Spain
facility: H. General Universitario Guadalajara
city: Madrid
country: Spain
facility: Hospital Universitario Infanta Leonor
city: Madrid
country: Spain
facility: Hospital Clínico San Carlos
city: Madrid
country: Spain
facility: Hospital Fundación Jimenez Diaz
city: Madrid
country: Spain
facility: Hospital Univ. La Paz
city: Madrid
country: Spain
facility: Hospital Univ. Ramón y Cajal
city: Malá
country: Spain
facility: Hospital Virgen de las Nieves
city: Murcia
country: Spain
facility: H. General Universitario Reina Sofía
city: Málaga
country: Spain
facility: Hospital Virgen de la Victoria
city: Sevilla
country: Spain
facility: Hospital Univ. Virgen del Rocio
city: Valencia
country: Spain
facility: H. Universitario y Politécnico La Fe
city: Valencia
country: Spain
facility: Hospital Univ. Clínico de Valencia
city: Zaragoza
country: Spain
facility: Hospital Univ. Lozano Blesa
Study officials:
affiliation: Hospital Univ. Ramón y Cajal
name: Santiago Moreno, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Univ. Ramón y Cajal
name: Sergio Serrano, MD
role: PRINCIPAL_INVESTIGATOR
References: