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Safety & Efficacy of Dual Therapy With Raltegravir/Lamivudine

NCT02284035 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2025-07-20

Study results available
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Summary

A pilot 24-week open-label, randomized, controlled clinical trial to assess the safety, tolerability and efficacy of dual therapy with Raltegravir/Lamivudine combination when replacing standard combination therapy in HIV-infected patients with prolonged virological suppression

Conditions

  • AIDS

Interventions

DRUG

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.

DRUG

EFV/TDF/FTC

standard combination therapy

DRUG

ATV/r + TDF/FTC or DRV/r + TDF/FTC

DRUG

DTG+ABC/3TC DTG+TDF/FTC EVG/cobi/TDF/FTC RAL+TDF/FTC

DRUG

EFV plus ABC/3TC or RPV/TDF/FTC

DRUG

ATV/r plus ABC/3TC

DRUG

DRV/r + ABC/3TC or LPV/r + ABC/3TC or LPV/r + TDF/FTC

DRUG

RAL plus ABC/3TC

DRUG

Other ART regimens

Sponsors & Collaborators

  • Juan A. Arnaiz

    lead OTHER

Principal Investigators

  • Esteban Martinez, MD PhD · Hospital Clinic of Barcelona

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-09-27
Primary Completion
2017-02-28
Completion
2017-02-28

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02284035 on ClinicalTrials.gov