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Study to Evaluate Darunavir/Ritonavir + Lamivudine Versus Continuing With Darunavir/Ritonavir + Tenofovir/Emtricitabine or Abacavir/Lamivudine in HIV Infected Subject

NCT02159599 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 249

Last updated 2017-02-14

No results posted yet for this study

Summary

This is an open label randomized clinial trial to evaluate the treatment with darunavir/ritonavir (800mg/100mg) plus lamivudine (300 mg) once daily versus continuing with darunavir/ritonavir (800mg/100mg) once daily plus tenofovir/emtricitabine (300mg/200mg) or abacavir/lamivudine (600mg/300mg) in HIV infected subject with suppressed plasma viremia.

Conditions

  • HIV Infection

Interventions

DRUG

Darunavir/Ritonavir

Darunavir/ritonavir (800/100 mg): QD (quaque die )

DRUG

Lamivudine

Lamivudine (300mg) : QD

DRUG

Emtricitabine/tenofovir or abacavir/lamivudine

Emtricitabine/tenofovir (300/200 mg) or abacavir/lamivudine (600/300 mg): QD

Sponsors & Collaborators

  • Janssen, LP

    collaborator INDUSTRY

  • Fundacion SEIMC-GESIDA

    lead OTHER

Principal Investigators

  • Jose R Arribas, MD · Hospital Universitario La Paz

  • Federico Pulido, MD · Hospital Universitario 12 de Octubre

  • Esteban Ribera, MD · Hospital Vall d'Hebron

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-07-31
Primary Completion
2016-04-30
Completion
2016-04-30

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 NCT02159599 on ClinicalTrials.gov