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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04076423




Registration number
NCT04076423
Ethics application status
Date submitted
27/08/2019
Date registered
3/09/2019
Date last updated
1/10/2024

Titles & IDs
Public title
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
Scientific 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
Secondary ID [1] 0 0
GeSIDA 10918
Universal Trial Number (UTN)
Trial acronym
InSTINCT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
HIV Infections 0 0
Condition category
Condition code
Infection 0 0 0 0
Studies of infection and infectious agents
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Sexually transmitted infections
Infection 0 0 0 0
Acquired immune deficiency syndrome (AIDS / HIV)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Dual Therapy
Treatment: Drugs - Triple therapy

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.

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.


Treatment: Drugs: Dual Therapy
DTG + 3TC

Treatment: Drugs: Triple therapy
BIC / FTC / TAF
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
sCD14
Timepoint [1] 0 0
Screening, basal, week 23, week 24, week 47, week 48, week 95 y week 96
Secondary outcome [1] 0 0
Changes in PCR-us
Timepoint [1] 0 0
Screening, basal, week 23, week 24, week 47, week 48, week 95 y week 96
Secondary outcome [2] 0 0
Changes in sCD163
Timepoint [2] 0 0
Screening, basal, week 23, week 24, week 47, week 48, week 95 y week 96
Secondary outcome [3] 0 0
Changes in quinurenine / tryptophan ratio
Timepoint [3] 0 0
Screening, basal, week 23, week 24, week 47, week 48, week 95 y week 96
Secondary outcome [4] 0 0
Changes in Dimer D
Timepoint [4] 0 0
Screening, basal, week 23, week 24, week 47, week 48, week 95 y week 96
Secondary outcome [5] 0 0
Changes in CD4/CD8 ratio
Timepoint [5] 0 0
Screening, basal, week 23, week 24, week 47, week 48, week 95 y week 96
Secondary outcome [6] 0 0
Changes in CD4+
Timepoint [6] 0 0
Throughout all the study, an average of 100 weeks
Secondary outcome [7] 0 0
Changes in viral suppression rates
Timepoint [7] 0 0
Throughout all the study, an average of 100 weeks
Secondary outcome [8] 0 0
Longitudinal trajectories of plasma biomarkers
Timepoint [8] 0 0
Throughout all the study, an average of 100 weeks
Secondary outcome [9] 0 0
Longitudinal trajectories of CD4/CD8 ratio
Timepoint [9] 0 0
Throughout all the study, an average of 100 weeks

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
10/10/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
16/01/2024
Sample size
Target
Accrual to date
Final
141
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
Spain
State/province [1] 0 0
La Rioja
Country [2] 0 0
Spain
State/province [2] 0 0
Madrid
Country [3] 0 0
Spain
State/province [3] 0 0
Barcelona
Country [4] 0 0
Spain
State/province [4] 0 0
Guadalajara
Country [5] 0 0
Spain
State/province [5] 0 0
Malá
Country [6] 0 0
Spain
State/province [6] 0 0
Murcia
Country [7] 0 0
Spain
State/province [7] 0 0
Málaga
Country [8] 0 0
Spain
State/province [8] 0 0
Sevilla
Country [9] 0 0
Spain
State/province [9] 0 0
Valencia
Country [10] 0 0
Spain
State/province [10] 0 0
Zaragoza

Funding & Sponsors
Primary sponsor type
Other
Name
Fundacion SEIMC-GESIDA
Address
Country

Ethics approval
Ethics application status

Summary
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)
Trial website
https://clinicaltrials.gov/study/NCT04076423
Trial related presentations / publications
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed

Contacts
Principal investigator
Name 0 0
Santiago Moreno, MD
Address 0 0
Hospital Univ. Ramón y Cajal
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04076423