CLINICAL TRIAL ASSESSING ONCE DAILY RALTEGRAVIR ADMINISTRATION (800 mg QD) IN HIV-1-INFECTED PATIENTS RECEIVING UNBOOSTED ATAZANAVIR (400 mg QD)-BASED ANTIRETROVIRAL THERAPY (ENSAYO CLÍNICO PARA EVALUAR LA ADMINISTRACIÓN DE RALTEGRAVIR UNA VEZ AL DÍA (800 mg QD) EN PACIENTES INFECTADOS POR EL VIH-1 QUE RECIBEN TERAPIA ANTIRETROVIRAL BASADA EN ATAZANAVIR NO POTENCIADO (400 mg QD))

• Conditions: Infección por VIH-1 (HIV-1 infection); MedDRA version: 9.1Level: LLTClassification code 10008919Term: Chronic HIV infection

• Registration Number: EUCTR2008-002695-94-ES
• Lead Sponsor: Fundació Lluita contra la SIDA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-05-21
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

1.Patients aged 18 to 65 years old with documented HIV-1 infection.
2.Patients on antiretroviral regimen that includes atazanavir 400mg QD for at least 4 weeks.
3.Complete virological suppression (<50 copies/mL) for at least 12 months.
4.Voluntary written informed consent.
5.Ability of compliance with visit schedule.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.AIDS defining condition within 4 weeks prior to the initiation of the study.
2.Concomitant treatment with ritonavir as well as with inducers (NNRTI, rifampin, carbamazepine, phenytoin, phenobarbital, valproic acid, etc) or inhibitors (probenecid, etc) of the uridine diphosphate glucuronyl transferase within 2 weeks before the screening visit.
3.Concomitant therapy with tenofovir.
4.History or suspected poor adherence to HAART.
5.History of drug allergy to raltegravir

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate raltegravir AUC24h and Cmin in HIV-infected patients receiving antiretroviral therapy including raltegravir and unboosted atazanavir.;Secondary Objective: •To evaluate the proportion of patients with raltegravir Cmin lower than 33 nM (IC95 in the presence of 50% human serum).<br>•To compare raltegravir AUC24h and Cmin between HIV-infected patients receiving antiretroviral therapy including raltegravir and unboosted atazanavir and historical controls taking raltegravir 400 mg BID without atazanavir. <br>•To evaluate safety of raltegravir 800 mg QD co-administered with atazanavir 400 mg QD in HIV-infected patients.<br>;Primary end point(s): To evaluate raltegravir AUC24h and Cmin in HIV-infected patients receiving antiretroviral therapy including raltegravir and unboosted atazanavir.