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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
History of Changes
  Purpose

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.


Condition Intervention Phase
HIV-1 Infection
HIV Infections
 Drug: Raltegravir
Drug: Etravirine
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Further study details as provided by Hospitales Universitarios Virgen del Rocío:

Primary Outcome Measures:
  • 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 ]

Enrollment: 16
Study Start Date: April 2010
Study Completion Date: January 2011
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Raltegravir
Raltegravir 400 mg bid
 Drug: Raltegravir
Changing the dose of raltegravir from 400 mg bid to 800 mg qd
Etravirine
Etravirine 200 mg bid
 Drug: Etravirine
Changing the dose of etravirine from 200 mg bid to 400 mg qd

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01121809

Locations
Spain
Hospitales Universitarios Virgen del Rocio
Sevilla, Spain, 41013
Sponsors and Collaborators
Hospitales Universitarios Virgen del Rocío
Investigators
Principal Investigator: Luis F Lopez-Cortes, ND, PhD Hospitales Universitarios Virgen del Rocío
  More Information

No publications provided

Responsible Party: Luis Fernando Lopez-Cortes, Hospitales Universitarios Virgen del Rocío
ClinicalTrials.gov Identifier: NCT01121809     History of Changes
Other Study ID Numbers: LLC-RAET-2009-1, 2009-014480-39
Study First Received: May 4, 2010
Last Updated: February 7, 2011
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by Hospitales Universitarios Virgen del Rocío:
Raltegravir
etravirine
pharmacokinetics
intracellular

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
 Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on May 21, 2013