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Completed

NCT Number: 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

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)

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Key information

Conditions

HIV Infections Blood-Borne Infections Communicable Diseases Genital Diseases Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital San Pedro, Logroño, La Rioja, Spain

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

dual therapy

Drug

DTG + 3TC

triple therapy

Drug

BIC / FTC / TAF

Primary outcomes

  1. sCD14

    Time frame: Screening, basal, week 23, week 24, week 47, week 48, week 95 y week 96

    Changes in sCD14 concentration

Secondary outcomes

  1. 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):

  2. Changes in sCD163

    Time frame: Screening, basal, week 23, week 24, week 47, week 48, week 95 y week 96

    Monocyte / macrophage activation

  3. 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

  4. Changes in Dimer D

    Time frame: Screening, basal, week 23, week 24, week 47, week 48, week 95 y week 96

    Coagulation

  5. Changes in CD4/CD8 ratio

    Time frame: Screening, basal, week 23, week 24, week 47, week 48, week 95 y week 96

    Inmunoactivation

  6. Changes in CD4+

    Time frame: Throughout all the study, an average of 100 weeks

  7. Changes in viral suppression rates

    Time frame: Throughout all the study, an average of 100 weeks

  8. 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.

  9. Longitudinal trajectories of CD4/CD8 ratio

    Time frame: Throughout all the study, an average of 100 weeks

Sponsors and collaborators

Lead sponsor

Fundacion SEIMC-GESIDA

Other

Registry information

Official study 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

Acronym: InSTINCT

Important dates

Study start
2019
Primary completion
2023
Study completion
2024
First posted
Sep 3, 2019
Registry last updated
Oct 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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