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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)

Primary Purpose

HIV Seropositivity, HIV Infections, HIV-1-infection

Status
Unknown status
Phase
Phase 3
Locations
Spain
Study Type
Interventional
Intervention
Raltegravir
Lamivudine
Sponsored by
David Garcia Cinca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Seropositivity focused on measuring Lamivudine, Raltegravir

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hospital Clínic i Provincial de BarcelonaRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Raltegravir + Lamivudine

Arm Description

Outcomes

Primary Outcome Measures

Therapeutic failure
therapeutic failure at week 48, includes virological failure, change in treatment for any reason, consent withdrawal, loss to follow-up or death

Secondary Outcome Measures

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

Full Information

First Posted
September 29, 2017
Last Updated
July 30, 2018
Sponsor
David Garcia Cinca
Collaborators
Fundacion Clinic per a la Recerca Biomédica
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1. Study Identification

Unique Protocol Identification Number
NCT03333083
Brief Title
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
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Unknown status
Study Start Date
May 3, 2018 (Actual)
Primary Completion Date
March 30, 2020 (Anticipated)
Study Completion Date
March 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
David Garcia Cinca
Collaborators
Fundacion Clinic per a la Recerca Biomédica

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Seropositivity, HIV Infections, HIV-1-infection
Keywords
Lamivudine, Raltegravir

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Raltegravir + Lamivudine
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Raltegravir
Intervention Description
Raltegravir (1200 mg once a day)
Intervention Type
Drug
Intervention Name(s)
Lamivudine
Intervention Description
Lamivudine (300 mg once a day)
Primary Outcome Measure Information:
Title
Therapeutic failure
Description
therapeutic failure at week 48, includes virological failure, change in treatment for any reason, consent withdrawal, loss to follow-up or death
Time Frame
48 weeks
Secondary Outcome Measure Information:
Title
Change from baseline in the reason of change of the antiretroviral treatment in those patients the reason of change was inconenience
Description
Changes in quality of life calculated by EQ-5D-5L if reason of switch was inconvenience
Time Frame
48 weeks
Title
Change from baseline in the reason of change of the antiretroviral treatment in those patients the reason of change was neurological toxicity
Description
Changes on Pittsburgh Sleep Quality Index for neurological toxicity
Time Frame
48 weeks
Title
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
Description
Changes on plasma lipids cholesterol LDL
Time Frame
48 weeks
Title
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
Description
Changes on plasma lipids cholesterol HDL
Time Frame
48 weeks
Title
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
Description
Changes on plasma lipids triglycerides
Time Frame
48 weeks
Title
Change from baseline in the reason of change of the antiretroviral treatment in those patients the reason of change was skeletal toxicity
Description
Changes on dual energy x-ray absorptiometry bone density
Time Frame
48 weeks
Title
Change from baseline in the reason of change of the antiretroviral treatment in those patients the reason of change was digestive toxicity
Description
Apperance of any adverse event that resolve their digestive toxicity: as diarrhea or digestive discomfort
Time Frame
48 weeks
Title
Change from baseline in the reason of change of the antiretroviral treatment in those patients the reason of change was drug-drug interactions
Description
Proportion of drug-drug interaction with antirretroviral treatment
Time Frame
48 weeks
Title
Therapeutic failure
Time Frame
24 weeks
Title
Virological failure
Description
Defined as two consecutive measurements of plasma viral load above 50 copies/ml
Time Frame
24 weeks
Title
Virological failure
Description
Defined as two consecutive measurements of plasma viral load above 50 copies/ml
Time Frame
48 weeks
Title
Proportion of patients with viral load below ultrasensitive HIV-1 RNA detection limit (limit of detection 1 copy/mL)
Time Frame
48 weeks
Title
Changes from baseline in cholesterol total
Time Frame
24 weeks
Title
Changes from baseline in HDL
Time Frame
24 weeks
Title
Changes from baseline in triglycerides
Time Frame
24 weeks
Title
Changes from baseline in insulin resistance (HOMA-IR)
Time Frame
24 weeks
Title
Changes from baseline in cholesterol LDL
Time Frame
24 weeks
Title
Changes from baseline in cholesterol LDL
Time Frame
48 weeks
Title
Changes from baseline in cholesterol total
Time Frame
48 weeks
Title
Changes from baseline in cholesterol HDL
Time Frame
48 weeks
Title
Changes from baseline in triglycerides
Time Frame
48 weeks
Title
Changes from baseline in and insulin resistance (HOMA-IR)
Time Frame
48 weeks
Title
Changes from baseline in body fat composition
Time Frame
48 weeks
Title
Changes from baseline in immune activation markers including CD38
Time Frame
48 weeks
Title
Changes from baseline in immune activation markers including HLA-DR
Time Frame
48 weeks
Title
Changes from baseline in biomarkers of inflammation IL-6,
Time Frame
48 weeks
Title
Changes from baseline in biomarkers of inflammation high sensitivity C-reactive protein
Time Frame
48 weeks
Title
Changes from baseline in biomarkers of mononuclear activation SD-14
Time Frame
48 weeks
Title
Changes from baseline in biomarkers of mononuclear activation SD-163
Time Frame
48 weeks
Title
Changes from baseline in sleep quality (Pittsburgh Sleep Quality Index)
Time Frame
24 weeks
Title
Changes from baseline in sleep quality (Pittsburgh Sleep Quality Index)
Time Frame
48 weeks
Title
Change from baseline in EQ-5D-5L
Time Frame
24 weeks
Title
Change from baseline in EQ-5D-5L
Time Frame
48 weeks
Title
Incidence of adverse events
Time Frame
48 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Esteban Martinez, MD
Phone
+34.93.227.54.00
Email
ESTEBANM@clinic.cat
Facility Information:
Facility Name
Hospital Clínic i Provincial de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Esteban Martinez, MD
Phone
+34.93.227.54.00
Email
ESTEBANM@clinic.cat
First Name & Middle Initial & Last Name & Degree
Esteban Martínez, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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