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

Study Overview
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Brief Summary
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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)

Official Title
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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)

Conditions
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HIV Infections, HIV-1-infection, HIV Seropositivity

Intervention / Treatment
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* Drug: Raltegravir
* Drug: Lamivudine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Raltegravir + Lamivudine<br>Lamivudine (300 mg QD) plusRaltegravir (1200 mg QD) | Drug: Raltegravir<br>* Raltegravir (1200 mg QD)<br>Drug: Lamivudine<br>* Lamivudine (300 mg QD)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with herapeutic 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 | 48 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with herapeutic 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 | 24 weeks | 
| Proportion of patients with viral load below ultrasensitive HIV-1 RNA detection limit (limit of detection 1 copy/mL) |  | 48 weeks | 
| Change from baseline in peripheral mononuclear blood cells HIV-1 reservoir |  | 48 weeks | 
| Changes from baseline in cholesterol total |  | 24 weeks | 
| Changes from baseline in cholesterol LDL |  | 24 weeks | 
| Changes from baseline in cholesterol HDL |  | 24 weeks | 
| Changes from baseline in triglycerides |  | 24 weeks | 
| Changes from baseline in insulin resistance (HOMA-IR) |  | 24 weeks | 
| Changes from baseline in cholesterol total |  | 48 weeks | 
| Changes from baseline in cholesterol LDL |  | 48 weeks | 
| Changes from baseline in triglycerides |  | 48 weeks | 
| Changes from baseline in insulin resistance (HOMA-IR) |  | 48 weeks | 
| Change from baseline in lumbar and femoral bone mineral density |  | 48 weeks | 
| Change from baseline in plasma 25-OH vitamin D levels |  | 48 weeks | 
| Change from baseline in urine beta-2-microglobulin |  | 48 weeks | 
| Change from baseline in estimated glomerular filtration rate (Chronic Kidney Disease Epidemiology CollaborationI) |  | 48 weeks | 
| Change from baseline in urine protein/creatinine ratio |  | 48 weeks | 
| Changes from baseline in biomarkers of inflammation IL-6 |  | 48 weeks | 
| Changes from baseline in biomarker of mononuclear activation SD-163 |  | 48 weeks | 
| Changes from baseline in biomarker of mononuclear activation SD-14 |  | 48 weeks | 
| Changes from baseline in biomarker of inflammation high sensitivity C-reactive protein |  | 48 weeks | 
| Changes from baseline in sleep quality (Pittsburgh Sleep Quality Index) at |  | 48 weeks | 
| Change from baseline in EQ-5D-5L |  | 48 weeks | 
| Incidence of adverse events |  | 48 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Raltegravir, Lamivudine