- ICH GCP
- US Clinical Trials Registry
- 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 (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
-
-
-
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
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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.
|
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.
|
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
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
- Pathologic Processes
- RNA Virus Infections
- Virus Diseases
- Blood-Borne Infections
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- Disease Attributes
- Slow Virus Diseases
- Urogenital Diseases
- Genital Diseases
- HIV Infections
- Inflammation
- Infections
- Communicable Diseases
- Acquired Immunodeficiency Syndrome
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.
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