Plasma and Intracellular Concentrations of Raltegravir and Etravirine Administered Once Daily

Study Overview
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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.

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.

Official Title
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Plasma and Intracellular Concentrations of Raltegravir and Etravirine Administered Once Daily (800 mg and 400 mg, Respectively) Compared With Standard Dosing (400 mg and 200 mg/12 h) in Patients With HIV Infection

Conditions
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HIV-1 Infection, HIV Infections

Intervention / Treatment
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* Drug: Raltegravir
* Drug: Etravirine


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Raltegravir<br>Raltegravir 400 mg bid | Drug: Raltegravir<br>* Changing the dose of raltegravir from 400 mg bid to 800 mg qd<br>|
| Other: Etravirine<br>Etravirine 200 mg bid | Drug: Etravirine<br>* Changing the dose of etravirine from 200 mg bid to 400 mg qd<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in pharmacokinetic parameters (Cmax, Cmin, AUC, t1/2, and Cl), both in plasma and intracellular, of RAL and ETV. |  | baseline and 1 week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Raltegravir, etravirine, pharmacokinetics, intracellular