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Darunavir/Ritonavir + Lamivudine Versus Darunavir/Ritonavir +Emtricitabine/Tenofovir in Naïve HIV-1 Infected Subjects

NCT02770508 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 145

Last updated 2018-08-03

No results posted yet for this study

Summary

The purpose of this study is to compare the safety and efficacy of a combination of a QD regimen consisting on ritonavir boosted darunavir (FDC) and lamivudine versus ritonavir boosted darunavir (FDC) plus co-formulated tenofovir and emtricitabine or co-formulated tenofovir/lamivudine in naïve HIV-1 infected patients. Subjects will be ARV-naïve HIV-1-infected patients eligible to start ARV therapy according to current guidelines.Subjects will be adults ≥ 18 years of age who meet all of the inclusion criteria and none of the exclusion criteria.

Conditions

  • HIV-1 Infection

Interventions

DRUG

darunavir/ritonavir

DRUG

Lamivudine

DRUG

emtricitabine-tenofovir(FTC/TDF)

Sponsors & Collaborators

  • Ministry of Science and Technology,Argentine

    collaborator UNKNOWN

  • National AIDS and STD programme,Argentine

    collaborator UNKNOWN

  • Richmond Laboratories

    collaborator UNKNOWN

  • Fundación Huésped

    lead OTHER

Principal Investigators

  • Pedro Cahn, PhD, MD · Fundacion Huesped

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-11-30
Primary Completion
2017-07-31
Completion
2017-10-31

Countries

  • Argentina

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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 NCT02770508 on ClinicalTrials.gov