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

This study has been completed.
Sponsor:
Information provided by:
Hospitales Universitarios Virgen del Rocío
ClinicalTrials.gov Identifier:
NCT01121809
First received: May 4, 2010
Last updated: February 7, 2011
Last verified: February 2011

May 4, 2010
February 7, 2011
April 2010
October 2010   (final data collection date for primary outcome measure)
Changes in pharmacokinetic parameters (Cmax, Cmin, AUC, t1/2, and Cl), both in plasma and intracellular, of RAL and ETV. [ Time Frame: baseline and 1 week ] [ Designated as safety issue: No ]
Changes in pharmacokinetic parameters (Cmax, Cmin, AUC, t1/2, and Cl), both in plasma and intracellular, of RAL and ETV. [ Time Frame: 1 week ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01121809 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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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

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.

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.

Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
  • HIV-1 Infection
  • HIV Infections
  • Drug: Raltegravir
    Changing the dose of raltegravir from 400 mg bid to 800 mg qd
  • Drug: Etravirine
    Changing the dose of etravirine from 200 mg bid to 400 mg qd
  • Raltegravir
    Raltegravir 400 mg bid
    Intervention: Drug: Raltegravir
  • Etravirine
    Etravirine 200 mg bid
    Intervention: Drug: Etravirine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
16
January 2011
October 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT01121809
LLC-RAET-2009-1, 2009-014480-39
Yes
Luis Fernando Lopez-Cortes, Hospitales Universitarios Virgen del Rocío
Hospitales Universitarios Virgen del Rocío
Not Provided
Principal Investigator: Luis F Lopez-Cortes, ND, PhD Hospitales Universitarios Virgen del Rocío
Hospitales Universitarios Virgen del Rocío
February 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP