Plasma and Intracellular Concentrations of Raltegravir and Etravirine Administered Once Daily (RAET)

Hospitales Universitarios Virgen del Rocío

Status and phase: Completed; Phase 4

Conditions: HIV-1 Infection; HIV Infections

Treatments: Drug: Etravirine; Drug: Raltegravir

Study type: Interventional

Funder types: Other

Identifiers

NCT01121809

LLC-RAET-2009-1

2009-014480-39 (EudraCT Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 16 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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16 participants in 2 patient groups

Raltegravir

Other group

Description:

Raltegravir 400 mg bid

Treatment:

Drug: Raltegravir

Etravirine

Other group

Description:

Etravirine 200 mg bid

Treatment:

Drug: Etravirine