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Plasma and Intracellular Concentrations of Raltegravir and Etravirine Administered Once Daily

NCT01121809 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2011-02-08

No results posted yet for this study

Summary

Hypothesis: the intracellular concentrations of raltegravir (RAL) and etravirine (ETV) administrated as 800 and 400 mg once a day, respectively, are similar to those obtained with the standard doses of 400 and 200 mg/12h, respectively.

Objective: To analyze the plasma and intracellular concentrations of RAL and ETV administrated as 800 and 400 mg once daily respectively compared with standard doses of 400 and 200 mg/12h, respectively, and if they support its once daily administration.

Conditions

  • HIV-1 Infection
  • HIV Infections

Interventions

DRUG

Raltegravir

Changing the dose of raltegravir from 400 mg bid to 800 mg qd

DRUG

Etravirine

Changing the dose of etravirine from 200 mg bid to 400 mg qd

Sponsors & Collaborators

  • Hospitales Universitarios Virgen del Rocío

    lead OTHER

Principal Investigators

  • Luis F Lopez-Cortes, ND, PhD · Hospitales Universitarios Virgen del Rocío

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2010-04-30
Primary Completion
2010-10-31
Completion
2011-01-31

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 NCT01121809 on ClinicalTrials.gov