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

HIV Infections Clinical Trial

— RALAM-II  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03333083
• Other study ID #: 2017-000985-31
• 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: +34.93.227.54.00
• Email: ESTEBANM[@]clinic.cat
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• 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:

• 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.

Related Conditions & MeSH terms

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

Intervention

Drug:
• Raltegravir
Raltegravir (1200 mg once a day)
• Lamivudine
Lamivudine (300 mg once a day)

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	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Therapeutic failure		24 weeks
Secondary	Virological failure	Defined as two consecutive measurements of plasma viral load above 50 copies/ml	24 weeks
Secondary	Virological failure	Defined as two consecutive measurements of plasma viral load above 50 copies/ml	48 weeks
Secondary	Proportion of patients with viral load below ultrasensitive HIV-1 RNA detection limit (limit of detection 1 copy/mL)		48 weeks
Secondary	Changes from baseline in cholesterol total		24 weeks
Secondary	Changes from baseline in 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 LDL		24 weeks
Secondary	Changes from baseline in cholesterol LDL		48 weeks
Secondary	Changes from baseline in cholesterol total		48 weeks
Secondary	Changes from baseline in cholesterol HDL		48 weeks
Secondary	Changes from baseline in triglycerides		48 weeks
Secondary	Changes from baseline in and insulin resistance (HOMA-IR)		48 weeks
Secondary	Changes from baseline in body fat composition		48 weeks
Secondary	Changes from baseline in immune activation markers including CD38		48 weeks
Secondary	Changes from baseline in immune activation markers including HLA-DR		48 weeks
Secondary	Changes from baseline in biomarkers of inflammation IL-6,		48 weeks
Secondary	Changes from baseline in biomarkers of inflammation high sensitivity C-reactive protein		48 weeks
Secondary	Changes from baseline in biomarkers of mononuclear activation SD-14		48 weeks
Secondary	Changes from baseline in biomarkers of mononuclear activation SD-163		48 weeks
Secondary	Changes from baseline in sleep quality (Pittsburgh Sleep Quality Index)		24 weeks
Secondary	Changes from baseline in sleep quality (Pittsburgh Sleep Quality Index)		48 weeks
Secondary	Change from baseline in EQ-5D-5L		24 weeks
Secondary	Change from baseline in EQ-5D-5L		48 weeks
Secondary	Incidence of adverse events		48 weeks