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Clinical Trial to Evaluate Drug-drug Interactions Between Darunavir/Cobicistat and Etravirine in Hiv- Infected Patients

NCT02818348 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2018-03-12

No results posted yet for this study

Summary

This study aims to provide information about the safety and pharmacokinetic drug-drug interactions between darunavir/cobicistat (800/150mg QD) and etravirine (400mg QD) in HIV-infected patients, as well as evaluate the efficacy of concomitant administration of darunavir/cobicistat and etravirine.

Conditions

  • HIV-1 Infection

Interventions

DRUG

darunavir/cobicistat

800/150 mg, once daily during 35 days + etravirine 400 mg, once daily during 14 days

DRUG

etravirine

400 mg, once daily during 28 days + darunavir/cobicistat 800/150 mg, once daily during 7 days

Sponsors & Collaborators

  • Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-06-30
Primary Completion
2016-10-31
Completion
2016-11-23

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 NCT02818348 on ClinicalTrials.gov