Study With Dual Therapy Including Lamivudine (300 mg QD) Plus Raltegravir (1200 mg QD) in Virologically Suppressed HIV-1 Infected Patients Experiencing Inconvenience, Toxicity, Negative Impact on Co-morbidities or Risk of Drug-drug Interactions With Their Current Regimen (RALAM-II)

Phase 3b, Single Arm, Simplification Study With Dual Therapy Including Lamivudine (300 mg QD) Plus Raltegravir (1200 mg QD) in Virologically Suppressed HIV-1 Infected Patients Experiencing Inconvenience, Toxicity, Negative Impact on Co-morbidities or Risk of Drug-drug Interactions With Their Current Regimen. (RALAM-II Study)

Phase 3b, single arm, simplification study with dual therapy including Lamivudine (300 mg QD) plus Raltegravir (1200 mg QD) in virologically suppressed HIV-1 infected patients experiencing inconvenience, toxicity, negative impact on comorbidities or risk of drug-drug interactions with their current regimen.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 17
• Phase: Phase 3

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain, 08036
    • Hospital Clinic i Provincial de Barcelona

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Eligible patients will be males or females at least 18 years of age. Women of childbearing potential must have a negative pregnancy test within 10 days prior to randomization into the study.
• Patients seropositive for HIV-1 using standard diagnostic criteria.
• Patients experiencing inconvenience, toxicity, negative impact on comorbidities or risk of drug-drug interactions with their current regimen
• Patients virologically suppressed during at least 12 months prior to inclusion (viral load <50 copies/mL).
• Patients who have signed informed consent to participate in the study.

Exclusion Criteria:

• Pregnancy, lactation, or planned pregnancy during the study period.
• Previous failure to an integrase inhibitor-containing regimen.
• Previous failure to a Lamivudine or Emtricitabine-containing regimen.
• Resistance mutations to Lamivudine or integrase inhibitor if any resistance test had been previously performed.
• Any disease or history of disease which, in the opinion of the investigator, might confound the results of the study or pose additional risk to patient treatment.
• Chronic hepatitis B.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Raltegravir + Lamivudine	Drug: Raltegravir; Raltegravir (1200 mg once a day); Drug: Lamivudine; Lamivudine (300 mg once a day)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Therapeutic failure	therapeutic failure at week 48, includes virological failure, change in 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 viral load below ultrasensitive HIV-1 RNA detection limit (limit of detection 1 copy/mL)		48 weeks
Changes from baseline in cholesterol total		24 weeks
Changes from baseline in cholesterol LDL		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
Change from baseline in EQ-5D-5L		48 weeks
Incidence of adverse events		48 weeks
Change from baseline in the reason of change of the antiretroviral treatment in those patients the reason of change was inconenience	Changes in quality of life calculated by EQ-5D-5L if reason of switch was inconvenience	48 weeks
Change from baseline in the reason of change of the antiretroviral treatment in those patients the reason of change was neurological toxicity	Changes on Pittsburgh Sleep Quality Index for neurological toxicity	48 weeks
Change from baseline in the reason of change of the antiretroviral treatment in those patients the reason of change was cardiovascular toxicity or co-morbidity	Changes on plasma lipids cholesterol LDL	48 weeks
Change from baseline in the reason of change of the antiretroviral treatment in those patients the reason of change was cardiovascular toxicity or co-morbidity	Changes on plasma lipids cholesterol HDL	48 weeks
Change from baseline in the reason of change of the antiretroviral treatment in those patients the reason of change was cardiovascular toxicity or co-morbidity	Changes on plasma lipids triglycerides	48 weeks
Change from baseline in the reason of change of the antiretroviral treatment in those patients the reason of change was skeletal toxicity	Changes on dual energy x-ray absorptiometry bone density	48 weeks
Change from baseline in the reason of change of the antiretroviral treatment in those patients the reason of change was digestive toxicity	Apperance of any adverse event that resolve their digestive toxicity: as diarrhea or digestive discomfort	48 weeks
Change from baseline in the reason of change of the antiretroviral treatment in those patients the reason of change was drug-drug interactions	Proportion of drug-drug interaction with antirretroviral treatment	48 weeks
Therapeutic failure		24 weeks
Virological failure	Defined as two consecutive measurements of plasma viral load above 50 copies/ml	24 weeks
Virological failure	Defined as two consecutive measurements of plasma viral load above 50 copies/ml	48 weeks
Changes from baseline in HDL		24 weeks
Changes from baseline in cholesterol HDL		48 weeks
Changes from baseline in and insulin resistance (HOMA-IR)		48 weeks
Changes from baseline in body fat composition		48 weeks
Changes from baseline in immune activation markers including CD38		48 weeks
Changes from baseline in immune activation markers including HLA-DR		48 weeks
Changes from baseline in biomarkers of inflammation IL-6,		48 weeks
Changes from baseline in biomarkers of inflammation high sensitivity C-reactive protein		48 weeks
Changes from baseline in biomarkers of mononuclear activation SD-14		48 weeks
Changes from baseline in biomarkers of mononuclear activation SD-163		48 weeks
Changes from baseline in sleep quality (Pittsburgh Sleep Quality Index)		24 weeks
Changes from baseline in sleep quality (Pittsburgh Sleep Quality Index)		48 weeks
Change from baseline in EQ-5D-5L		24 weeks

Collaborators and Investigators

• Sponsor: Judit Pich
• Collaborators: Fundacion Clinic per a la Recerca Biomédica

Study record dates

Study Major Dates

• Study Start (Actual): May 3, 2018
• Primary Completion (Actual): June 25, 2020
• Study Completion (Actual): June 25, 2020

Study Registration Dates

• First Submitted: September 29, 2017
• First Submitted That Met QC Criteria: November 2, 2017
• First Posted (Actual): November 6, 2017

Study Record Updates

• Last Update Posted (Actual): May 18, 2025
• Last Update Submitted That Met QC Criteria: May 14, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Lamivudine; Raltegravir
• Additional Relevant MeSH Terms: Blood-Borne Infections; Urogenital Diseases; Genital Diseases; Pathologic Processes; Disease Attributes; Immune System Diseases; RNA Virus Infections; Virus Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; HIV Infections; Infections; Communicable Diseases; HIV Seropositivity; Anti-Infective Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Nucleic Acid Synthesis Inhibitors; Antiviral Agents; Reverse Transcriptase Inhibitors; Anti-HIV Agents; Anti-Retroviral Agents; HIV Integrase Inhibitors; Integrase Inhibitors; Raltegravir Potassium; Lamivudine
• Other Study ID Numbers: RALAM-II; 2017-000985-31 (EudraCT Number)

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
• product manufactured in and exported from the U.S.: No