Tripe Versus Dual Antiretroviral Therapy in HIV-infected Patients With Virological Suppression (Tridual)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

153 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-01

Study Completion Date

2021-02-03

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The persistence of an aberrant state of immune activation and inflammation (pIA) may contribute to the emergence of serious non-AIDS events which carry a higher morbimortality in HIV-infected patients. Although combined antiretroviral treatment (cART) reduces both cellular and soluble activation markers, it fails to completely control pIA despite consistent plasma viral load suppression. One of the mechanisms involved in pIA is may be an incomplete suppression of viral replication not reflected by plasma viral load, which only reflects a balance between viral replication and clearance of HIV-RNA. In addition, low-level viremia detected in most HIV-1-infected patients despite years on cART. Unintegrated 2-LTR HIV-DNA, and cellular associated HIV-RNAs, as products of active integrated DNA transcription, support this issue.

Furthermore, the key rationales behind simplifying cART are a reduction of toxicities, lower risk of resistance mutations in case of virological failure and saving costs. One of these simplification strategies is a dual therapy which, based on the data up to date and in our clinical experience, has similar virological efficacy than cART. However, it is unknown if this strategy could increase the persistent HIV-1 replication and, therefore, pIA. The CD4+/CD8+ T cell ratio as a marker of immune recovery, the changes in T cell immune activation, senescence, exhaustion and apoptosis, and the cellular associated HIV-DNA and -RNA would answer the question if simplification to dual therapy would provide less control of residual HIV replication and, therefore, a detriment on pIA compared to triple therapy and, therefore, would worsen the patients' long-term prognosis.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT04076423

HIV Infections

COMPLETED PHASE4

Administration of High Doses of Antiretroviral Drugs to Eliminate the Latent HIV-1 Reservoir

NCT06640192

HIV-1-infection

RECRUITING PHASE2

Comparison of Inflammatory Markers and Incidence of Comorbidities in Patients on Antiretroviral Therapy With Second-generation Anti-integrase Drugs on Triple Versus Dual Therapy

NCT05699785

Hiv

RECRUITING NA

Evaluation of the Efficacy and Safety Between Two Antiretroviral Regimens, in HIV-1-infected Treatment-naïve Subjects With Low CD4 Counts

NCT01928407

HIV-1 Infection Immunosuppression-related Infectious Disease

COMPLETED PHASE4

Duration of Dual Antiretroviral Therapy in Virologically Suppressed People Living With HIV and Factors Associated With Switching to Tritherapy : a Real-life Cohort

NCT06107140

HIV Infections

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Primary Outcome Measures: to evaluate the changes in the CD4/CD8 ratio, immune activation and other immunologic parameters at 48 weeks after switching to dual therapy based on dolutegravir plus emtricitabine o darunavir/cobicistat plus emtricitabine versus to continue on triple therapy based on integrase inhibitor plus 2 analogs Secondary Outcome Measures: to evaluate the changes in the CD4/CD8 ratio, immune activation and other immunologic parameters at 96 weeks after switching to dual therapy based on dolutegravir plus emtricitabine o darunavir/cobicistat plus emtricitabine versus to continue on triple therapy based on integrase inhibitor plus 2 analogs

Method: randomized clinical trial in which adult HIV-infected patients with an undetectable plasma HIV-RNA for at least one year on a triple therapy based on integrase inhibitors plus two nucleos(t)ide analogs will be randomized in 3 groups (1:1:1) with 4 strata according to the previous time with undetectable viral load to:

1. Continue the previous ART based on Elvitegravircobicistat 150150 mg + tenofovir alafenamide 10 mg + emtricitabine 200 mg (Genvoya™) o Dolutegravir 50 mg + abacavir 600 mg + lamivudine 300 mg (Triumeq™) once daily.

Or to switch to:
2. Darunavir/cobicistat (800150 mg) + 3TC (300 mg) once daily or
3. Dolutegravir (50 mg) + 3TC (300 mg) once daily.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

HIV Infections

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Triple therapy

To Continue with triple therapy with Elvitegravir/cobicistat + tenofovir alafenamide + emtricitabine or Dolutegravir + abacavir + lamivudine once daily.

Group Type ACTIVE_COMPARATOR

Continue with triple therapy

Intervention Type DRUG

To continue with triple therapy

Switch to dual therapy A

Switch to dual therapy with Darunavir/cobicistat (800150 mg) + lamivudine (300 mg) once daily once daily.

Group Type EXPERIMENTAL

Switch to DTG + 3TC

Intervention Type DRUG

Switch to dolutegravir + lamivudine once daily

Switch to dual therapy B

Switch to dual therapy with Dolutegravir (50 mg) + lamivudine (300 mg) once daily

Group Type EXPERIMENTAL

Switch to DRV/cobicistat + 3TC

Intervention Type DRUG

Switch to darunavir/cobicistat + lamivudine once daily

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Continue with triple therapy

To continue with triple therapy

Intervention Type DRUG

Switch to DTG + 3TC

Switch to dolutegravir + lamivudine once daily

Intervention Type DRUG

Switch to DRV/cobicistat + 3TC

Switch to darunavir/cobicistat + lamivudine once daily

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* HIV-1-infected patients ≥ 18 years of age.
* Starting date of antiretroviral treatment later than 01/01/2010
* Plasma HIV-1 RNA \<20 copies/ml for at least one year on triple therapy
* Antiretroviral treatment based on an integrase inhibitor plus two nucleos(t)ide analogs in the last 6 months.
* Signed written informed consent prior to inclusion.

Exclusion Criteria

* Primary resistance to any of the drugs included in the study.
* Active opportunistic infection.
* Pregnancy at inclusion or during the follow-up
* Active hepatitis C and/or B virus co-infection.
* Cirrhosis, portal hypertension and/or hypersplenism of any etiology.
* Current or past malignancies subsidiary of treatment with corticosteroids, immunomodulatory agents, interferon or chemotherapeutic agents.
* Any laboratory abnormality grade 3 or 4 according to the U.S. Department of Health and Human Services, National Institutes of Health, National Institute of Allergy and Infectious Diseases, Division of AIDS.
* Concomitant use of drugs with potential major interactions with the prescribed drugs according to the respective full prescribing information.
* Estimated creatinine clearance \<50 ml/min

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No