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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)

Primary Purpose

HIV Infections, HIV-1-infection, HIV Seropositivity

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 Infections focused on measuring Raltegravir, Lamivudine

Eligibility Criteria

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

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

Sites / Locations

  • Hospital Clínic i Provincial de BarcelonaRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Raltegravir + Lamivudine

Arm Description

Lamivudine (300 mg QD) plusRaltegravir (1200 mg QD)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
Proportion of patients with viral load below ultrasensitive HIV-1 RNA detection limit (limit of detection 1 copy/mL)
Change from baseline in peripheral mononuclear blood cells HIV-1 reservoir
Changes from baseline in cholesterol total
Changes from baseline in cholesterol LDL
Changes from baseline in cholesterol HDL
Changes from baseline in triglycerides
Changes from baseline in insulin resistance (HOMA-IR)
Changes from baseline in cholesterol total
Changes from baseline in cholesterol LDL
Changes from baseline in triglycerides
Changes from baseline in insulin resistance (HOMA-IR)
Change from baseline in lumbar and femoral bone mineral density
Change from baseline in plasma 25-OH vitamin D levels
Change from baseline in urine beta-2-microglobulin
Change from baseline in estimated glomerular filtration rate (Chronic Kidney Disease Epidemiology CollaborationI)
Change from baseline in urine protein/creatinine ratio
Changes from baseline in biomarkers of inflammation IL-6
Changes from baseline in biomarker of mononuclear activation SD-163
Changes from baseline in biomarker of mononuclear activation SD-14
Changes from baseline in biomarker of inflammation high sensitivity C-reactive protein
Changes from baseline in sleep quality (Pittsburgh Sleep Quality Index) at
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
NCT03311945
Brief Title
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
Acronym
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)
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, 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)

6. Conditions and Keywords

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

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Raltegravir + Lamivudine
Arm Type
Experimental
Arm Description
Lamivudine (300 mg QD) plusRaltegravir (1200 mg QD)
Intervention Type
Drug
Intervention Name(s)
Raltegravir
Intervention Description
Raltegravir (1200 mg QD)
Intervention Type
Drug
Intervention Name(s)
Lamivudine
Intervention Description
Lamivudine (300 mg QD)
Primary Outcome Measure Information:
Title
Proportion of patients with herapeutic failure
Description
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
Time Frame
48 weeks
Secondary Outcome Measure Information:
Title
Proportion of patients with herapeutic failure
Description
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
Time Frame
24 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
Change from baseline in peripheral mononuclear blood cells HIV-1 reservoir
Time Frame
48 weeks
Title
Changes from baseline in cholesterol total
Time Frame
24 weeks
Title
Changes from baseline in cholesterol LDL
Time Frame
24 weeks
Title
Changes from baseline in cholesterol 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 total
Time Frame
48 weeks
Title
Changes from baseline in cholesterol LDL
Time Frame
48 weeks
Title
Changes from baseline in triglycerides
Time Frame
48 weeks
Title
Changes from baseline in insulin resistance (HOMA-IR)
Time Frame
48 weeks
Title
Change from baseline in lumbar and femoral bone mineral density
Time Frame
48 weeks
Title
Change from baseline in plasma 25-OH vitamin D levels
Time Frame
48 weeks
Title
Change from baseline in urine beta-2-microglobulin
Time Frame
48 weeks
Title
Change from baseline in estimated glomerular filtration rate (Chronic Kidney Disease Epidemiology CollaborationI)
Time Frame
48 weeks
Title
Change from baseline in urine protein/creatinine ratio
Time Frame
48 weeks
Title
Changes from baseline in biomarkers of inflammation IL-6
Time Frame
48 weeks
Title
Changes from baseline in biomarker of mononuclear activation SD-163
Time Frame
48 weeks
Title
Changes from baseline in biomarker of mononuclear activation SD-14
Time Frame
48 weeks
Title
Changes from baseline in biomarker of inflammation high sensitivity C-reactive protein
Time Frame
48 weeks
Title
Changes from baseline in sleep quality (Pittsburgh Sleep Quality Index) at
Time Frame
48 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: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Esteban Martinez, MD
Phone
+34.227.54.00
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
+34.227.54.00
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

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

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