Simplification Study of HIV-1 Infected Patients With Virological Suppression Under the Combination of Lamivudine (150 mg BID) Plus Raltegravir (400 mg BID) Switching to Lamivudine (300 mg QD) Plus Raltegravir (1200 mg QD) : Roll-over Study of the RALAM

Phase 3CompletedNCT03311945

Judit Pich33 enrolled

Overview

Phase 3b, single arm, single site simplification study of HIV-1 infected patients with virological suppression under the combination of Lamivudine (150 mg BID) plus Raltegravir (400 mg BID) switching to Lamivudine (300 mg QD) plus Raltegravir (1200 mg QD): Roll-over study of the RALAM clinical trial (NCT02284035)

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

HIV Infections HIV-1-infection HIV Seropositivity

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients in the switch arm who have completed the 24-week follow-up of RALAM (NCT02284035) study and remain virologically suppressed (viral load \<50 copies/mL) on dual therapy with lamivudine plus Raltegravir * Patients who have signed informed consent to participate in the study. Exclusion Criteria: * Pregnancy, lactation, or planned pregnancy during the study period * Any disease or history of disease which, in opinion of the investigator, might confound the results of the study or pose additional risk to patient treatment * Hepatitis B co-infection

Outcomes

Primary Outcomes

Proportion of Patients With Therapeutic Failure

Proportion of patients that at least present one of the following events: virological failure, change in antirretroviral treatment for any reason, consent withdrawal, loss to follow-up or death.

Time frame: 48 weeks

Secondary Outcomes

Change From Baseline in Peripheral Mononuclear Blood Cells HIV-1 Reservoir

Time frame: 48 weeks

Changes From Baseline in Cholesterol Total

Time frame: 24 weeks

Changes From Baseline in Cholesterol LDL

Time frame: 24 weeks

Changes From Baseline in Cholesterol 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

Change From Baseline in Lumbar and Femoral Bone Mineral Density

Time frame: 48 weeks

Change From Baseline in Plasma 25-OH Vitamin D Levels

Time frame: 48 weeks

Change From Baseline in Urine Beta-2-microglobulin

Time frame: 48 weeks

Change From Baseline in Estimated Glomerular Filtration Rate (Chronic Kidney Disease Epidemiology CollaborationI)

Time frame: 48 weeks

Change From Baseline in Urine Protein/Creatinine Ratio

Time frame: 48 weeks

Changes From Baseline in Biomarkers of Inflammation IL-6

Time frame: 48 weeks

Changes From Baseline in Biomarker of Mononuclear Activation SD-163

Time frame: 48 weeks

Changes From Baseline in Biomarker of Mononuclear Activation SD-14

Time frame: 48 weeks

Changes From Baseline in Biomarker of Inflammation High Sensitivity C-reactive Protein

Time frame: 48 weeks

Changes From Baseline in Sleep Quality (Pittsburgh Sleep Quality Index) at

Time frame: 48 weeks

Change From Baseline in EQ-5D-5L

Time frame: 48 weeks

Incidence of Adverse Events

Time frame: 48 weeks

Viral Load

Proportion of patients with viral load below ultrasensitive HIV-1 RNA detection limit (limit of detection 1 copy/mL) at 48 weeks

Time frame: 48 weeks

Simplification Study of HIV-1 Infected Patients With Virological Suppression Under the Combination of Lamivudine (150 mg BID) Plus Raltegravir (400 mg BID) Switching to Lamivudine (300 mg QD) Plus Raltegravir (1200 mg QD) : Roll-over Study of the RALAM

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes