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 3

• Conditions: HIV Infections; HIV-1-infection; HIV Seropositivity
• Interventions: Drug: Raltegravir; Drug: Lamivudine

• Registration Number: NCT03311945
• Lead Sponsor: David Garcia Cinca

Brief Summary

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)

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-09-29
• Study First Submitted QC: 2017-10-11
• Study First Posted: 2017-10-17
• Study Start: 2018-05-03
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-30
• Last Update Posted: 2018-07-31
• Primary Completion: 2020-03-30
• Study Completion: 2020-03-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 49

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Raltegravir + Lamivudine	Raltegravir	Lamivudine (300 mg QD) plusRaltegravir (1200 mg QD)
Raltegravir + Lamivudine	Lamivudine	Lamivudine (300 mg QD) plusRaltegravir (1200 mg QD)

Primary Outcome Measures

Name	Time	Method
Proportion of patients with herapeutic failure	48 weeks	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

Secondary Outcome Measures

Name	Time	Method
Change from baseline in peripheral mononuclear blood cells HIV-1 reservoir	48 weeks
Changes from baseline in triglycerides	48 weeks
Change from baseline in plasma 25-OH vitamin D levels	48 weeks
Changes from baseline in cholesterol total	48 weeks
Changes from baseline in cholesterol LDL	48 weeks
Changes from baseline in cholesterol HDL	24 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 urine beta-2-microglobulin	48 weeks
Change from baseline in estimated glomerular filtration rate (Chronic Kidney Disease Epidemiology CollaborationI)	48 weeks
Proportion of patients with herapeutic failure	24 weeks	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
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 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

Trial Locations

Locations (1)

Hospital Clínic i Provincial de Barcelona; 🇪🇸 Barcelona, Spain