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

HIV Infections Clinical Trial

— RALAM-RollOver  

Official title:

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03311945
• Other study ID #: 2017-000986-60
• Status: Recruiting
• Phase: Phase 3
• Start date: May 3, 2018
• Est. completion date: March 30, 2020

Study information

• Verified date: July 2018
• Source: Hospital Clinic of Barcelona
• Contact: Esteban Martinez, MD
• Phone: +34.227.54.00
• Email: ESTEBANM[@]clinic.cat
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 49
• Est. completion date: March 30, 2020
• Est. primary completion date: March 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• HIV Infections
• HIV Seropositivity
• HIV-1-infection
• Infection

Intervention

Drug:
• Raltegravir
Raltegravir (1200 mg QD)
• Lamivudine
Lamivudine (300 mg QD)

Locations

Country	Name	City	State
Spain	Hospital Clínic i Provincial de Barcelona	Barcelona

Sponsors (2)

Lead Sponsor	Collaborator
David Garcia Cinca	Fundacion Clinic per a la Recerca Biomédica

Country where clinical trial is conducted

Spain, 

Outcome

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