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

NCT ID: NCT04076423

Last Updated: 2024-10-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 141 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-10
• Study Completion Date: 2024-01-16

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)

Conditions

HIV Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Triple therapy

Intervention Type: DRUG

BIC / FTC / TAF

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.

Group Type: ACTIVE_COMPARATOR

Dual Therapy

Intervention Type: DRUG

DTG + 3TC

Interventions

Dual Therapy

DTG + 3TC

Intervention Type: DRUG

Triple therapy

BIC / FTC / TAF

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fundacion SEIMC-GESIDA

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Santiago Moreno, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Univ. Ramón y Cajal

Sergio Serrano, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Univ. Ramón y Cajal

Locations

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

Hospital de Bellvitge

Barcelona, , Spain

Hospital Univ. Vall D'Hebron

Barcelona, , Spain

H. General Universitario Guadalajara

Guadalajara, , Spain

Hospital Universitario Infanta Leonor

Madrid, , 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

H. General Universitario Reina Sofía

Murcia, , Spain

Hospital Univ. Virgen del Rocio

Seville, , Spain

H. Universitario y Politécnico La Fe

Valencia, , Spain

Hospital Univ. Clínico de Valencia

Valencia, , Spain

Hospital Univ. Lozano Blesa

Zaragoza, , Spain

Countries

Spain

References

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.

Reference Type: DERIVED

PMID: 39055703 (View on PubMed)

Other Identifiers

GeSIDA 10918

Identifier Type: -

Identifier Source: org_study_id