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

HIV Infections Clinical Trial

— InSTINCT  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04076423
• Other study ID #: GeSIDA 10918
• Status: Completed
• Phase: Phase 4
• Start date: October 10, 2019
• Est. completion date: January 16, 2024

Study information

• Verified date: June 2024
• Source: Fundacion SEIMC-GESIDA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 141
• Est. completion date: January 16, 2024
• Est. primary completion date: June 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• Communicable Diseases
• HIV Infections
• Infections
• Inflammation

Intervention

Drug:
• Dual Therapy
DTG + 3TC
• Triple therapy
BIC / FTC / TAF

Locations

Country	Name	City	State
Spain	Hospital General de Alicante	Alicante
Spain	H. Clinic i Provincial	Barcelona
Spain	Hospital de Bellvitge	Barcelona
Spain	Hospital Univ. Vall D'Hebron	Barcelona
Spain	Hospital Reina Sofia	Córdoba
Spain	Hospital Clínico San Carlos	Madrid
Spain	Hospital Fundación Jimenez Diaz	Madrid
Spain	Hospital Univ. de La Princesa	Madrid
Spain	Hospital Univ. La Paz	Madrid
Spain	Hospital Univ. Ramón y Cajal	Madrid
Spain	Hospital Virgen de las Nieves	Malá
Spain	Hospital Regional Carlos Haya	Málaga
Spain	Hospital Virgen de la Victoria	Málaga
Spain	Hospital de Santiago	Santiago De Compostela
Spain	Hospital Univ. Virgen del Rocio	Sevilla
Spain	Hospital Univ. Clínico de Valencia	Valencia
Spain	Hospital Univ. Lozano Blesa	Zaragoza

Sponsors (1)

Lead Sponsor	Collaborator
Fundacion SEIMC-GESIDA

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	sCD14	Changes in sCD14 concentration	Screening, basal, week 23, week 24, week 47, week 48, week 95 y week 96
Secondary	Changes in PCR-us	Inflammation (IL-6 signaling pathways):	Screening, basal, week 23, week 24, week 47, week 48, week 95 y week 96
Secondary	Changes in sCD163	Monocyte / macrophage activation	Screening, basal, week 23, week 24, week 47, week 48, week 95 y week 96
Secondary	Changes in quinurenine / tryptophan ratio	IDO-1 induction	Screening, basal, week 23, week 24, week 47, week 48, week 95 y week 96
Secondary	Changes in Dimer D	Coagulation	Screening, basal, week 23, week 24, week 47, week 48, week 95 y week 96
Secondary	Changes in CD4/CD8 ratio	Inmunoactivation	Screening, basal, week 23, week 24, week 47, week 48, week 95 y week 96
Secondary	Changes in CD4+		Throughout all the study, an average of 100 weeks
Secondary	Changes in viral suppression rates		Throughout all the study, an average of 100 weeks
Secondary	Longitudinal trajectories of plasma biomarkers	The differences in the trajectories of soluble inflammatory markers by comparing the slopes of each biomarker between treatment arms. Longitudinal changes in each biomarker will be compared using linear or non-linear mixed models with random intercepts, depending on the normality of the data.	Throughout all the study, an average of 100 weeks
Secondary	Longitudinal trajectories of CD4/CD8 ratio		Throughout all the study, an average of 100 weeks