Asymptomatic HIV Infection
Conditions
Interventions
Trade Name: Videx
Product Name: Videx 400
Product Code: 63303
Pharmaceutical Form: Capsule*
INN or Proposed INN: Didanosine
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration
Sponsors
Asociación para el estudio de enfermedades infecciosas
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate food efect on antiviral activity of videx enteric-coated capsules ;Secondary Objective: To measure the plasmatic and intracelular levels when videx enteric-coated capsules are administered with food ;Primary end point(s): Decrease in plasmatic viral load through 1 month | — |
Countries
Spain
Outcome results
None listed