Plasma and Intracellular Concentrations of Raltegravir and Etravirine Administered Once Daily

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2011-01-31

Brief Summary

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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.

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Detailed Description

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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.

Method: Phase IV, prospective, open labelled clinical trial with a planned duration of 24 weeks in which 16 patients from Hospitales Universitarios Virgen del Rocío will be enrolled. A 12 hours pharmacokinetic profile (immediately before and after 1, 2, 3, 4, 6, 8, 10 and 12 h) will be obtained after a supervised drug intake while taking RAL or ETV bid. Afterwards,the patients will take RAL or ETV once a day for 7 - 10 days. Subsequently, a new pharmacokinetic profile (predose and after 1, 2, 3, 4, 6, 8, 10, 12, 16, 20 and 24 h after a supervised drug intake) will be obtained.

Conditions

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HIV-1 Infection HIV Infections

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Raltegravir

Raltegravir 400 mg bid

Group Type OTHER

Raltegravir

Intervention Type DRUG

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

Etravirine

Etravirine 200 mg bid

Group Type OTHER

Etravirine

Intervention Type DRUG

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

Interventions

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Raltegravir

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

Intervention Type DRUG

Etravirine

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Adult HIV-1-infected patients taking raltegravir- or etravirine-based antiretroviral regimens

Exclusion Criteria

* Pregnancy
* Concomitant use of drugs that have potential interactions with raltegravir or etravirine pharmacokinetics
* Cirrhosis with clinical or analytic data of liver failure.
* Clinical history suggesting malabsorption or presence of diarrhea (\> 3 stools / day) that could interfere with the absorption of study drugs.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No