Safety & Efficacy of Dual Therapy With Raltegravir/Lamivudine
NCT ID: NCT02284035
Last Updated: 2025-07-20
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
75 participants
INTERVENTIONAL
2015-09-27
2017-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Group 1 Raltegravir / 3TC (MK0518B
Raltegravir / 3TC (MK0518B ) (50 patients)
Raltegravir/3TC
MK0518B (Raltegravir/3TC) (300mg/150mg) twice daily, administered orally in the 300/150 mg film-coated tablets according to instructions in the prescribing information.
Group 2 standard combination therapy
NNRTI-Based Regimen:
• EFV/TDF/FTC
PI-Based Regimens:
ATV/r + TDF/FTC or DRV/r + TDF/FTC
INSTI-Based Regimens:
DTG+ABC/3TC DTG+TDF/FTC EVG/cobi/TDF/FTC RAL+TDF/FTC
NNRTI-Based Regimens:
EFV plus ABC/3TC or RPV/TDF/FTC
PI-Based Regimen:
ATV/r plus ABC/3TC
PI-Based Regimens:
DRV/r + ABC/3TC or LPV/r + ABC/3TC or LPV/r + TDF/FTC
INSTI-Based Regimen:
RAL plus ABC/3TC
And other ART regimens
EFV/TDF/FTC
standard combination therapy
ATV/r + TDF/FTC or DRV/r + TDF/FTC
DTG+ABC/3TC DTG+TDF/FTC EVG/cobi/TDF/FTC RAL+TDF/FTC
EFV plus ABC/3TC or RPV/TDF/FTC
ATV/r plus ABC/3TC
DRV/r + ABC/3TC or LPV/r + ABC/3TC or LPV/r + TDF/FTC
RAL plus ABC/3TC
Other ART regimens
Interventions
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Raltegravir/3TC
MK0518B (Raltegravir/3TC) (300mg/150mg) twice daily, administered orally in the 300/150 mg film-coated tablets according to instructions in the prescribing information.
EFV/TDF/FTC
standard combination therapy
ATV/r + TDF/FTC or DRV/r + TDF/FTC
DTG+ABC/3TC DTG+TDF/FTC EVG/cobi/TDF/FTC RAL+TDF/FTC
EFV plus ABC/3TC or RPV/TDF/FTC
ATV/r plus ABC/3TC
DRV/r + ABC/3TC or LPV/r + ABC/3TC or LPV/r + TDF/FTC
RAL plus ABC/3TC
Other ART regimens
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Patients seropositive for HIV-1 using standard diagnostic criteria.
3. Patients virologically suppressed during at least 12 months prior to inclusion (viral load \<50 copies/mL).
4. Patients on combination antiretroviral therapy (at least 2 antiretroviral drugs) for at least 12 months before being randomized in this study.
5. Patients who are clinically stable in the opinion of the investigator at study entry (clinical status and chronic medication must not have not been modified at least 14 days prior to randomization).
6. Patients who have signed informed consent to participate in the study.
Exclusion Criteria
2. Previous failure to an integrase inhibitor-containing regimen.
3. Previous failure to a 3TC or FTC-containing regimen.
4. Resistance mutations to 3TC or integrase inhibitor if any resistance test had been previously performed.
5. 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.
6. Chronic hepatitis B.
18 Years
ALL
No
Sponsors
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Juan A. Arnaiz
OTHER
Responsible Party
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Juan A. Arnaiz
Head Clinical Trials Unit
Principal Investigators
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Esteban Martinez, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Hospital Clinic of Barcelona
Locations
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Hospital Clinic
Barcelona, , Spain
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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2014-003142-27
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
RALAM
Identifier Type: -
Identifier Source: org_study_id
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