Plasma and Intracellular Concentrations of Raltegravir and Etravirine Administered Once Daily

NCT01121809 | Completed Phase 4 DMC

• 2 other identifiers: LLC-RAET-2009-12009-014480-39
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV-1 Infection; HIV Infections

Keywords

Raltegravir; etravirine; pharmacokinetics; intracellular

Outcome Measures

Primary Outcomes (1)

• Changes in pharmacokinetic parameters (Cmax, Cmin, AUC, t1/2, and Cl), both in plasma and intracellular, of RAL and ETV.

  baseline and 1 week

Study Arms (2)

Raltegravir

OTHER

Raltegravir 400 mg bid

Drug: Raltegravir

Etravirine

OTHER

Etravirine 200 mg bid

Drug: Etravirine

Interventions

Raltegravir DRUG

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

Raltegravir

Etravirine DRUG

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

Etravirine

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult HIV-1-infected patients taking raltegravir- or etravirine-based antiretroviral regimens

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospitales Universitarios Virgen del Rocío: lead

Study Sites (1)

Hospitales Universitarios Virgen del Rocio

Seville, Sevilla, 41013, Spain

Location

Related Publications (1)

• 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.

  PMID: 22190606 DERIVED

MeSH Terms

Conditions

HIV Infections

Interventions

Raltegravir Potassium; etravirine

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Luis F Lopez-Cortes, ND, PhD

  Hospitales Universitarios Virgen del Rocío

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 4, 2010
• First Posted: May 12, 2010
• Study Start: April 1, 2010
• Primary Completion: October 1, 2010
• Study Completion: January 1, 2011
• Last Updated: February 8, 2011

Record last verified: 2011-02

Locations

ES (1)