HIV InfectionsPhase 4InSTINCTNCT04076423
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
A Phase 4 study testing Dual Therapy and Triple therapy in people with HIV Infections, run by Fundacion SEIMC-GESIDA at 18 sites in Spain.
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) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- Dual Therapy and Triple therapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 141 participants
- Where
- 18 sitesSpain
- Study dates
- 10 Oct 2019to 16 Jan 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
Spain18 sites
Hospital Universitario Príncipe de Asturias
Alcalá de Henares, Madrid, 28002
Hospital de Bellvitge
Barcelona
Hospital Univ. Vall D'Hebron
Barcelona
H. General Universitario Guadalajara
Guadalajara
Hospital San Pedro
Logroño, La Rioja, 26006
Hospital Universitario Infanta Leonor
Madrid, 28050
Hospital Clínico San Carlos
Madrid
Hospital Fundación Jimenez Diaz
Madrid
Hospital Univ. La Paz
Madrid
Hospital Univ. Ramón y Cajal
Madrid
Hospital Universitario Puerta de Hierro
Majadahonda, Madrid, 28222
Hospital Virgen de las Nieves
Malá
Hospital Virgen de la Victoria
Málaga
H. General Universitario Reina Sofía
Murcia, 30003
Hospital Univ. Virgen del Rocio
Seville
H. Universitario y Politécnico La Fe
Valencia, 46026
Hospital Univ. Clínico de Valencia
Valencia
Hospital Univ. Lozano Blesa
Zaragoza
About this study
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
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)
- Conditions
- HIV Infections
- Being tested
- Dual Therapy, Triple therapy
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dual TherapyDrug
DTG + 3TC
Triple therapyDrug
BIC / FTC / TAF
| Study group | Role | What they receive |
|---|---|---|
| Experimental arm: | Experimental | they will take 1 tablet (50 mg BIC + 200 mg FTC + 25 mg TAF), orally, once a day, from the moment of randomization. Receives: Drug: Triple therapy |
| Comparator arm | Active comparator | 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. Receives: Drug: Dual Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
sCD14
Changes in sCD14 concentration
Measured: Screening, basal, week 23, week 24, week 47, week 48, week 95 y week 96
Secondary outcomes (9)
Changes in PCR-us
Inflammation (IL-6 signaling pathways):
Measured: Screening, basal, week 23, week 24, week 47, week 48, week 95 y week 96
Changes in sCD163
Monocyte / macrophage activation
Measured: Screening, basal, week 23, week 24, week 47, week 48, week 95 y week 96
Changes in quinurenine / tryptophan ratio
IDO-1 induction
Measured: Screening, basal, week 23, week 24, week 47, week 48, week 95 y week 96
Changes in Dimer D
Coagulation
Measured: Screening, basal, week 23, week 24, week 47, week 48, week 95 y week 96
Changes in CD4/CD8 ratio
Inmunoactivation
Measured: Screening, basal, week 23, week 24, week 47, week 48, week 95 y week 96
Changes in CD4+
Measured: Throughout all the study, an average of 100 weeks
Changes in viral suppression rates
Measured: Throughout all the study, an average of 100 weeks
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.
Measured: Throughout all the study, an average of 100 weeks
Longitudinal trajectories of CD4/CD8 ratio
Measured: Throughout all the study, an average of 100 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2019
- Study start10 Oct 2019
- Primary completion15 Jun 2023
- Study completion16 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Comparator: the patient will continue taking the dual therapy. Experimental: the patient Will beging to take triple therapy.
- Masking
- None (open label)
- Enrolment
- 141 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundacion SEIMC-GESIDA
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Santiago Moreno, MD, Principal investigator, Hospital Univ. Ramón y CajalSergio Serrano, MD, Principal investigator, Hospital Univ. Ramón y Cajal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04076423
- Sponsor's protocol ID
- GeSIDA 10918
- Acronym
- InSTINCT
- Status last verified
- Jun 2024
- First submitted
- 27 Aug 2019
- Last updated
- 1 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Saborido-Alconchel A, Serna-Gallego A, Trujillo-Rodriguez M, Munoz-Muela E, Alvarez-Rios AI, Lozano C, Llaves-Flores S, Espinosa N, Roca-Oporto C, Herrero M, Sotomayor C, Gutierrez-Valencia A, Lopez-Cortes LF. Long-term effects on immunological, inflammatory markers, and HIV-1 reservoir after switching to a two-drug versus maintaining a three-drug regimen based on integrase inhibitors. Front Immunol. 2024 Jul 11;15:1423734. doi: 10.3389/fimmu.2024.1423734. eCollection 2024.
PubMed 39055703
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04076423
- Acronym / sponsor ID
- InSTINCT / GeSIDA 10918
- Conditions
- HIV Infections
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 141 participants (actual)
- Lead sponsor
- Fundacion SEIMC-GESIDAUniversity, hospital or other
- Study start
- 10 Oct 2019 (actual)
- Primary completion
- 15 Jun 2023 (actual)
- Study completion
- 16 Jan 2024 (actual)
- First posted
- 3 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Comparator: the patient will continue taking the dual therapy. Experimental: the patient Will beging to take triple therapy.
| Arm | Type | Receives |
|---|---|---|
| Experimental arm: | Experimental | Drug: Triple therapythey will take 1 tablet (50 mg BIC + 200 mg FTC + 25 mg TAF), orally, once a day, from the moment of randomization. |
| Comparator arm | Active comparator | Drug: Dual Therapythey 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dual TherapyDTG + 3TC | Drug | Comparator arm |
| Triple therapyBIC / FTC / TAF | Drug | Experimental arm: |
Primary outcome
sCD14
Time frame: Screening, basal, week 23, week 24, week 47, week 48, week 95 y week 96
Changes in sCD14 concentration
9 secondary outcomes
Changes in PCR-us
Time frame: 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
Changes in quinurenine / tryptophan ratio
Time frame: 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
Changes in CD4/CD8 ratio
Time frame: 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
Changes in viral suppression rates
Time frame: 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
Longitudinal trajectories of CD4/CD8 ratio
Time frame: Throughout all the study, an average of 100 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2024.
- Derived from this study: PubMed 39055703Saborido-Alconchel A, Serna-Gallego A, Trujillo-Rodriguez M, Munoz-Muela E, Alvarez-Rios AI, Lozano C, Llaves-Flores S, Espinosa N, Roca-Oporto C, Herrero M, Sotomayor C, Gutierrez-Valencia A, Lopez-Cortes LF. Long-term effects on immunological, inflammatory markers, and HIV-1 reservoir after switching to a two-drug versus maintaining a three-drug regimen based on integrase inhibitors. Front Immunol. 2024 Jul 11;15:1423734. doi: 10.3389/fimmu.2024.1423734. eCollection 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Santiago Moreno, MD principal investigator
Hospital Univ. Ramón y Cajal
Sergio Serrano, MD principal investigator
Hospital Univ. Ramón y Cajal
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dual Therapy and Triple therapy in people with HIV Infections, run by Fundacion SEIMC-GESIDA at 18 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sCD14 (time frame: Screening, basal, week 23, week 24, week 47, week 48, week 95 y week 96). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04076423, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2024.