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

Phase 4

Completed

• Conditions: HIV Infections
• Interventions: Drug: Triple therapy; Drug: Dual Therapy

• Registration Number: NCT04076423
• Lead Sponsor: Fundacion SEIMC-GESIDA

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)

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-08-27
• Study First Submitted QC: 2019-08-30
• Study First Posted: 2019-09-03
• Study Start: 2019-10-10
• Primary Completion: 2023-06-15
• Study Completion: 2024-01-16
• Status Verified: 2024-06
• Last Update Submitted: 2024-09-30
• Last Update Posted: 2024-10-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 141

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental arm:	Triple therapy	they will take 1 tablet (50 mg BIC + 200 mg FTC + 25 mg TAF), orally, once a day, from the moment of randomization.
Comparator arm	Dual Therapy	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.

Primary Outcome Measures

Name	Time	Method
sCD14	Screening, basal, week 23, week 24, week 47, week 48, week 95 y week 96	Changes in sCD14 concentration

Secondary Outcome Measures

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

Trial Locations

Locations (18)

Hospital San Pedro; 🇪🇸 Logroño, La Rioja, Spain

Hospital Universitario Príncipe de Asturias; 🇪🇸 Alcalá De Henares, Madrid, Spain

Hospital Universitario Puerta de Hierro; 🇪🇸 Majadahonda, Madrid, Spain

H. General Universitario Guadalajara; 🇪🇸 Guadalajara, Spain

Hospital Universitario Infanta Leonor; 🇪🇸 Madrid, Spain

H. General Universitario Reina Sofía; 🇪🇸 Murcia, Spain

H. Universitario y Politécnico La Fe; 🇪🇸 Valencia, Spain

Hospital de Bellvitge; 🇪🇸 Barcelona, Spain

Hospital Univ. Vall D'Hebron; 🇪🇸 Barcelona, Spain

Hospital Clínico San Carlos; 🇪🇸 Madrid, Spain

Hospital Fundación Jimenez Diaz; 🇪🇸 Madrid, Spain

Hospital Univ. La Paz; 🇪🇸 Madrid, Spain

Hospital Univ. Ramón y Cajal; 🇪🇸 Madrid, Spain

Hospital Virgen de las Nieves; 🇪🇸 Malá, Spain

Hospital Virgen de la Victoria; 🇪🇸 Málaga, Spain

Hospital Univ. Virgen del Rocio; 🇪🇸 Sevilla, Spain

Hospital Univ. Clínico de Valencia; 🇪🇸 Valencia, Spain

Hospital Univ. Lozano Blesa; 🇪🇸 Zaragoza, Spain