Study With Dual Therapy Including Lamivudine (300 mg QD) Plus Raltegravir (1200 mg QD) in Virologically Suppressed HIV-1 Infected Patients Experiencing Inconvenience, Toxicity, Negative Impact on Co-morbidities or Risk of Drug-drug Interactions With Their Current Regimen

Phase 3TerminatedNCT03333083

Judit Pich17 enrolled

Overview

Phase 3b, single arm, simplification study with dual therapy including Lamivudine (300 mg QD) plus Raltegravir (1200 mg QD) in virologically suppressed HIV-1 infected patients experiencing inconvenience, toxicity, negative impact on comorbidities or risk of drug-drug interactions with their current regimen.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

HIV Seropositivity HIV Infections HIV-1-infection

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Eligible patients will be males or females at least 18 years of age. Women of childbearing potential must have a negative pregnancy test within 10 days prior to randomization into the study. * Patients seropositive for HIV-1 using standard diagnostic criteria. * Patients experiencing inconvenience, toxicity, negative impact on comorbidities or risk of drug-drug interactions with their current regimen * Patients virologically suppressed during at least 12 months prior to inclusion (viral load \<50 copies/mL). * Patients who have signed informed consent to participate in the study. Exclusion Criteria: * Pregnancy, lactation, or planned pregnancy during the study period. * Previous failure to an integrase inhibitor-containing regimen. * Previous failure to a Lamivudine or Emtricitabine-containing regimen. * Resistance mutations to Lamivudine or integrase inhibitor if any resistance test had been previously performed. * Any disease or history of disease which, in the opinion of the investigator, might confound the results of the study or pose additional risk to patient treatment. * Chronic hepatitis B.

Outcomes

Primary Outcomes

Therapeutic failure

therapeutic failure at week 48, includes virological failure, change in treatment for any reason, consent withdrawal, loss to follow-up or death

Time frame: 48 weeks

Secondary Outcomes

Change from baseline in the reason of change of the antiretroviral treatment in those patients the reason of change was inconenience

Changes in quality of life calculated by EQ-5D-5L if reason of switch was inconvenience

Time frame: 48 weeks

Change from baseline in the reason of change of the antiretroviral treatment in those patients the reason of change was neurological toxicity

Changes on Pittsburgh Sleep Quality Index for neurological toxicity

Time frame: 48 weeks

Change from baseline in the reason of change of the antiretroviral treatment in those patients the reason of change was cardiovascular toxicity or co-morbidity

Changes on plasma lipids cholesterol LDL

Time frame: 48 weeks

Change from baseline in the reason of change of the antiretroviral treatment in those patients the reason of change was cardiovascular toxicity or co-morbidity

Changes on plasma lipids cholesterol HDL

Time frame: 48 weeks

Change from baseline in the reason of change of the antiretroviral treatment in those patients the reason of change was cardiovascular toxicity or co-morbidity

Changes on plasma lipids triglycerides

Time frame: 48 weeks

Change from baseline in the reason of change of the antiretroviral treatment in those patients the reason of change was skeletal toxicity

Changes on dual energy x-ray absorptiometry bone density

Time frame: 48 weeks

Change from baseline in the reason of change of the antiretroviral treatment in those patients the reason of change was digestive toxicity

Apperance of any adverse event that resolve their digestive toxicity: as diarrhea or digestive discomfort

Time frame: 48 weeks

Change from baseline in the reason of change of the antiretroviral treatment in those patients the reason of change was drug-drug interactions

Proportion of drug-drug interaction with antirretroviral treatment

Time frame: 48 weeks

Therapeutic failure

Time frame: 24 weeks

Virological failure

Defined as two consecutive measurements of plasma viral load above 50 copies/ml

Time frame: 24 weeks

Virological failure

Defined as two consecutive measurements of plasma viral load above 50 copies/ml

Time frame: 48 weeks

Proportion of patients with viral load below ultrasensitive HIV-1 RNA detection limit (limit of detection 1 copy/mL)

Time frame: 48 weeks

Changes from baseline in cholesterol total

Time frame: 24 weeks

Changes from baseline in HDL

Time frame: 24 weeks

Changes from baseline in triglycerides

Time frame: 24 weeks

Changes from baseline in insulin resistance (HOMA-IR)

Time frame: 24 weeks

Changes from baseline in cholesterol LDL

Time frame: 24 weeks

Changes from baseline in cholesterol LDL

Time frame: 48 weeks

Changes from baseline in cholesterol total

Time frame: 48 weeks

Changes from baseline in cholesterol HDL

Time frame: 48 weeks

Changes from baseline in triglycerides

Time frame: 48 weeks

Changes from baseline in and insulin resistance (HOMA-IR)

Time frame: 48 weeks

Changes from baseline in body fat composition

Time frame: 48 weeks

Changes from baseline in immune activation markers including CD38

Time frame: 48 weeks

Changes from baseline in immune activation markers including HLA-DR

Time frame: 48 weeks

Changes from baseline in biomarkers of inflammation IL-6,

Time frame: 48 weeks

Changes from baseline in biomarkers of inflammation high sensitivity C-reactive protein

Time frame: 48 weeks

Changes from baseline in biomarkers of mononuclear activation SD-14

Time frame: 48 weeks

Changes from baseline in biomarkers of mononuclear activation SD-163

Time frame: 48 weeks

Changes from baseline in sleep quality (Pittsburgh Sleep Quality Index)

Time frame: 24 weeks

Changes from baseline in sleep quality (Pittsburgh Sleep Quality Index)

Time frame: 48 weeks

Change from baseline in EQ-5D-5L

Time frame: 24 weeks

Change from baseline in EQ-5D-5L

Time frame: 48 weeks

Incidence of adverse events

Time frame: 48 weeks

Study With Dual Therapy Including Lamivudine (300 mg QD) Plus Raltegravir (1200 mg QD) in Virologically Suppressed HIV-1 Infected Patients Experiencing Inconvenience, Toxicity, Negative Impact on Co-morbidities or Risk of Drug-drug Interactions With Their Current Regimen

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes