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 (InSTINCT)

January 31, 2024 updated by: Fundacion SEIMC-GESIDA

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

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)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

141

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental arm:
they will take 1 tablet (50 mg BIC + 200 mg FTC + 25 mg TAF), orally, once a day, from the moment of randomization.
Drug: Triple therapy
BIC / FTC / TAF
Active Comparator: Comparator arm
they will take 1 tablet of 50 mg of DTG orally, once a day + 1 tablet of 300 mg of 3TC orally, once a day, from the randomization moment.
Drug: Dual Therapy
DTG + 3TC

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
sCD14
Time Frame: Screening, basal, week 23, week 24, week 47, week 48, week 95 y week 96
Changes in sCD14 concentration
Screening, basal, week 23, week 24, week 47, week 48, week 95 y week 96

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in PCR-us
Time Frame: Screening, basal, week 23, week 24, week 47, week 48, week 95 y week 96
Inflammation (IL-6 signaling pathways):
Screening, basal, week 23, week 24, week 47, week 48, week 95 y week 96
Changes in sCD163
Time Frame: Screening, basal, week 23, week 24, week 47, week 48, week 95 y week 96
Monocyte / macrophage activation
Screening, basal, week 23, week 24, week 47, week 48, week 95 y week 96
Changes in quinurenine / tryptophan ratio
Time Frame: Screening, basal, week 23, week 24, week 47, week 48, week 95 y week 96
IDO-1 induction
Screening, basal, week 23, week 24, week 47, week 48, week 95 y week 96
Changes in Dimer D
Time Frame: Screening, basal, week 23, week 24, week 47, week 48, week 95 y week 96
Coagulation
Screening, basal, week 23, week 24, week 47, week 48, week 95 y week 96
Changes in CD4/CD8 ratio
Time Frame: Screening, basal, week 23, week 24, week 47, week 48, week 95 y week 96
Inmunoactivation
Screening, basal, week 23, week 24, week 47, week 48, week 95 y week 96
Changes in CD4+
Time Frame: Throughout all the study, an average of 100 weeks
Throughout all the study, an average of 100 weeks
Changes in viral suppression rates
Time Frame: Throughout all the study, an average of 100 weeks
Throughout all the study, an average of 100 weeks
Longitudinal trajectories of plasma biomarkers
Time Frame: Throughout all the study, an average of 100 weeks
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
Longitudinal trajectories of CD4/CD8 ratio
Time Frame: Throughout all the study, an average of 100 weeks
Throughout all the study, an average of 100 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundacion SEIMC-GESIDA

Investigators

  • Principal Investigator: Santiago Moreno, MD, Hospital Univ. Ramón y Cajal
  • Principal Investigator: Sergio Serrano, MD, Hospital Univ. Ramón y Cajal

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 10, 2019

Primary Completion (Actual)

June 15, 2023

Study Completion (Actual)

January 16, 2024

Study Registration Dates

First Submitted

August 27, 2019

First Submitted That Met QC Criteria

August 30, 2019

First Posted (Actual)

September 3, 2019

Study Record Updates

Last Update Posted (Actual)

February 1, 2024

Last Update Submitted That Met QC Criteria

January 31, 2024

Last Verified

June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GeSIDA 10918

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on HIV Infections

Clinical Trials on Triple therapy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Cote d'Ivoire

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe