Food effect on antiviral activity of videx enteric-coated capsules

• Conditions: Asymptomatic HIV Infection

• Registration Number: EUCTR2004-002565-20-ES
• Lead Sponsor: Asociación para el estudio de enfermedades infecciosas

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2004-10-26
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Age > = 18 years
Asymptomatic HIV infection
No previous antiretroviral treatment
CD4 lymphocyte> 350 u/L
Viral load> 5000 and > 60000
Karnofsky index >= 70
Absence of substance abuse comsumption

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

Pregnancy or breastfeeding
Enrollment in any other clinical trial
Previous history of pancreatitis, increase amilase level 2 times ULN or previous or current polineuropathy
Ribavirin concomitant treatment
Any other drugs with antiretroviral activity

Study & Design

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