Plasma and Intracellular Concentrations of Raltegravir and Etravirine Administered Once Daily (RAET)
Primary Purpose
HIV-1 Infection, HIV Infections
Status
Completed
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
Raltegravir
Etravirine
Sponsored by
About this trial
This is an interventional treatment trial for HIV-1 Infection focused on measuring Raltegravir, etravirine, pharmacokinetics, intracellular
Eligibility 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.
Sites / Locations
- Hospitales Universitarios Virgen del Rocio
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Raltegravir
Etravirine
Arm Description
Raltegravir 400 mg bid
Etravirine 200 mg bid
Outcomes
Primary Outcome Measures
Changes in pharmacokinetic parameters (Cmax, Cmin, AUC, t1/2, and Cl), both in plasma and intracellular, of RAL and ETV.
Secondary Outcome Measures
Full Information
NCT ID
NCT01121809
First Posted
May 4, 2010
Last Updated
February 7, 2011
Sponsor
Hospitales Universitarios Virgen del Rocío
1. Study Identification
Unique Protocol Identification Number
NCT01121809
Brief Title
Plasma and Intracellular Concentrations of Raltegravir and Etravirine Administered Once Daily
Acronym
RAET
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2011
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
January 2011 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Hospitales Universitarios Virgen del Rocío
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV-1 Infection, HIV Infections
Keywords
Raltegravir, etravirine, pharmacokinetics, intracellular
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Raltegravir
Arm Type
Other
Arm Description
Raltegravir 400 mg bid
Arm Title
Etravirine
Arm Type
Other
Arm Description
Etravirine 200 mg bid
Intervention Type
Drug
Intervention Name(s)
Raltegravir
Intervention Description
Changing the dose of raltegravir from 400 mg bid to 800 mg qd
Intervention Type
Drug
Intervention Name(s)
Etravirine
Intervention Description
Changing the dose of etravirine from 200 mg bid to 400 mg qd
Primary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luis F Lopez-Cortes, ND, PhD
Organizational Affiliation
Hospitales Universitarios Virgen del Rocío
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospitales Universitarios Virgen del Rocio
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
12. IPD Sharing Statement
Citations:
PubMed Identifier
22190606
Citation
Gutierrez-Valencia A, Martin-Pena R, Torres-Cornejo A, Ruiz-Valderas R, Castillo-Ferrando JR, Lopez-Cortes LF. Intracellular and plasma pharmacokinetics of 400 mg of etravirine once daily versus 200 mg of etravirine twice daily in HIV-infected patients. J Antimicrob Chemother. 2012 Mar;67(3):681-4. doi: 10.1093/jac/dkr534. Epub 2011 Dec 21.
Results Reference
derived
Learn more about this trial
Plasma and Intracellular Concentrations of Raltegravir and Etravirine Administered Once Daily
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