Plasma and Intracellular Concentrations of Raltegravir and Etravirine Administered Once Daily

• Status: Completed
• Trial end date: 2011-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hospitales Universitarios Virgen del Rocío
• Treatments: Etravirine; Raltegravir Potassium

Criteria

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.