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 (RALAM-RollOver)

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)

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 Overview

• Status: Unknown
• Conditions: HIV Infections; HIV Seropositivity; HIV-1-infection
• Intervention / Treatment: Drug: Raltegravir; Drug: Lamivudine

• Study Type: Interventional
• Enrollment (Anticipated): 49
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Esteban Martinez, MD; Phone Number: +34.227.54.00; Email: ESTEBANM@clinic.cat

Study Locations

• Spain
  • Barcelona, Spain, 08036
    • Recruiting
    • Hospital Clinic i Provincial de Barcelona
    • Contact: Esteban Martinez, MD; Phone Number: +34.227.54.00; Email: ESTEBANM@clinic.cat

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Raltegravir + Lamivudine; Lamivudine (300 mg QD) plusRaltegravir (1200 mg QD)	Drug: Raltegravir; Raltegravir (1200 mg QD); Drug: Lamivudine; Lamivudine (300 mg QD)

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: David Garcia Cinca
• Collaborators: Fundacion Clinic per a la Recerca Biomédica

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 3, 2018
• Primary Completion (ANTICIPATED): March 30, 2020
• Study Completion (ANTICIPATED): March 30, 2020

Study Registration Dates

• First Submitted: September 29, 2017
• First Submitted That Met QC Criteria: October 11, 2017
• First Posted (ACTUAL): October 17, 2017

Study Record Updates

• Last Update Posted (ACTUAL): July 31, 2018
• Last Update Submitted That Met QC Criteria: July 30, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: Lamivudine; Raltegravir
• Additional Relevant MeSH Terms: Pathologic Processes; RNA Virus Infections; Virus Diseases; Blood-Borne Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; Disease Attributes; HIV Infections; Infections; Communicable Diseases; HIV Seropositivity; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Reverse Transcriptase Inhibitors; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Anti-HIV Agents; Anti-Retroviral Agents; HIV Integrase Inhibitors; Integrase Inhibitors; Raltegravir Potassium; Lamivudine
• Other Study ID Numbers: 2017-000986-60

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No