DTG/3TC vs. BIC/FTC/TAF Maintenance Therapy in People Living With HIV:

Status Active, not recruiting

Clinical Trial Summary

The hypothesize that DTG/3TC will be non-inferior to BIC/FTC/TAF with a 4% margin in virologically suppressed HIV-infected patients. The study will allow claiming for Superiority. Assuming that both DTG and BIC may lead to similar weight gains (approximately 1 kg after 48 weeks) in virologically suppressed HIV-infected patients and that TAF may induce a further weight gain (approximately 1 kg after 48 weeks), also hypothesize that switching to BIC/FTC/TAF may lead to greater weight gain than switching to DTG/3TC over 48 weeks. This trial is a Phase IV, open-label, randomized multicentre clinical trial evaluating the efficacy of DTG/3TC versus BIC/FTC/TAF for the maintenance of virological suppression in HIV patients.

Clinical Trial Description

Participants will be randomly assigned in a 1:1 ratio to receive DTG/3TC or BIC/FTC/TAF. Randomization will be stratified by sex and TAF use at baseline. At least 33% of the patients included will be women. The investigatora will also endeavour to recruit as many non-Caucasian participants as possible. Patients with TAF-containing regimens at baseline will be limited to 25% or less of the total number of participants. Three sub-studies will be performed: Omics sub-study ; Senescence sub-study; Fat biopsies sub-study. Omics sub-study: Assess the mechanistic pathways involved on weight changes associated with switching to BIC/FTC/TAF vs. DTG/3TC. Senescence sub-study: Assess the potential effects on the telomere length, epigenetic age and oxidative stress markers of switching to BIC/FTC/TAF vs. DTG/3TC. Fat biopsies sub-study: To assess potential effects of switching to BIC/FTC/TAF vs. DTG/3TC on expression of marker genes of mitochondrial function, adipogenesis, and inflammation in subcutaneous fat tissue. Assays on adipose tissue gene expression will be complemented by analysis in serum of adipokines representative of adipose tissue function (leptin, adiponectin), and inflammation biomarkers (TNFalpha, MCP-1, IL-6, IL- 8, IL-10, IL-18). ;

Study Design

Related Conditions & MeSH terms

HIV-1-infection

Clinical Trial Details

NCT number	NCT04884139
Study type	Interventional
Source	Fundacion SEIMC-GESIDA
Contact
Status	Active, not recruiting
Phase	Phase 4
Start date	July 14, 2021
Completion date	January 1, 2025

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT03940521` - Bioclinical Evaluation of 2 Biomarkers of Aviremic HIV-1 in CD4+ T Cells of Adults Undergoing Treatment
Completed	`NCT03227731` - Immediate or Deferred Pre-exposure Prophylaxis for HIV Prevention: Safe Options for Pregnant and Lactating Women	Phase 2/Phase 3
Completed	`NCT03570918` - MGD014 in HIV-Infected Individuals on Suppressive Antiretroviral Therapy	Phase 1
Not yet recruiting	`NCT06336434` - CREATE - Cabotegravir & Rilpivirine Antiretroviral Therapy in Pregnancy	Phase 1/Phase 2
Active, not recruiting	`NCT04022967` - ANRS 12372 MODERATO Study	Phase 3
Not yet recruiting	`NCT06337032` - A Study to Provide Continued Access to Study Drug to Children and Adolescents Who Have Completed Clinical Studies Involving Gilead HIV Treatments	Phase 4
Not yet recruiting	`NCT06282783` - Studying Topiramate for Re-Activating the HIV-1 Reservoir	Phase 1/Phase 2
Completed	`NCT04711265` - Antibody Response to Prophylactic QHPV Vaccine at 48 Months Among HIV-infected Girls and Boys
Recruiting	`NCT03536234` - Efficacy and Safety of GnRH Analogue Triptorelin for HIV-1 Reservoir Reduction in ART Treated HIV-1 Infected Patients	Phase 2
Completed	`NCT04340388` - Contribution of Dolutegravir to Obesity and Cardiovascular Disease	Phase 4
Withdrawn	`NCT05769569` - Safety and Efficacy of Neutralizing Antibodies and Vaccination for Induction of HIV Remission	Phase 1
Enrolling by invitation	`NCT05584397` - Comparing Immune Activation and Latent HIV Reservoir Size Between People Living With HIV on Tenofovir-containing Versus NRTI-free ART
Completed	`NCT04963712` - Zadaxin and HIV-positive Patients With Immune Reconstitution Disorder	Early Phase 1
Completed	`NCT04388904` - Rapid Reinitiation of a Single Tablet Antiretroviral Therapy Using Symtuza® in HIV-1 Infected Treatment-Experienced Patients Off Therapy. (ReSTART)	Phase 4
Not yet recruiting	`NCT04894357` - Impact of V106I on Resistance to Doravirine
Completed	`NCT04568239` - Impact of M184V on the Virological Efficacy to 3TC/DTG (LAMRES)
Not yet recruiting	`NCT04311944` - Early Fast-Track Versus Standard Care for Persons With HIV Initiating TLD	N/A
Not yet recruiting	`NCT04311957` - Continuation of Protease-Inhibitor Based Second-Line Therapy vs. Switch to B/F/TAF in Virologically Suppressed Adults	Phase 4
Not yet recruiting	`NCT04513496` - Telemedicine in HIV Care in Buenos Aires
Completed	`NCT03998176` - Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF) in HIV-1 Infected Patients With Active Illicit Substance usE	Phase 4

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

DTG/3TC vs. BIC/FTC/TAF Maintenance Therapy in People Living With HIV: — PASO-DOBLE

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms