Plasma and Intracellular Concentrations of Raltegravir and Etravirine Administered Once Daily

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01121809

Acronym

RAET

Enrollment

Registered

2010-05-12

Start date

2010-04-30

Completion date

2011-01-31

Last updated

2011-02-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV-1 Infection, HIV Infections

Keywords

Raltegravir, etravirine, pharmacokinetics, intracellular

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.

Interventions

DRUGRaltegravir

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

DRUGEtravirine

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	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

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 27, 2026