Plasma and Intracellular Concentrations of Raltegravir and Etravirine Administered Once Daily

Phase 4

Completed

• Conditions: HIV Infections; HIV-1 Infection
• Interventions: Drug: Raltegravir; Drug: Etravirine

• Registration Number: NCT01121809
• Lead Sponsor: Hospitales Universitarios Virgen del Rocío

Brief 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.

Detailed Description

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.

Study Timeline

• Study Start: 2010-04
• Study First Submitted: 2010-05-04
• Study First Submitted QC: 2010-05-10
• Study First Posted: 2010-05-12
• Primary Completion: 2010-10
• Study Completion: 2011-01
• Status Verified: 2011-02
• Last Update Submitted: 2011-02-07
• Last Update Posted: 2011-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Raltegravir	Raltegravir	Raltegravir 400 mg bid
Etravirine	Etravirine	Etravirine 200 mg bid

Primary Outcome Measures

Name	Time	Method
Changes in pharmacokinetic parameters (Cmax, Cmin, AUC, t1/2, and Cl), both in plasma and intracellular, of RAL and ETV.	baseline and 1 week

Trial Locations

Locations (1)

Hospitales Universitarios Virgen del Rocio; 🇪🇸 Sevilla, Spain