HIV infected patients
Conditions
Interventions
Trade Name: Videx
Product Name: Didanosina
Pharmaceutical Form: Capsule*
Concentration unit: mg milligram(s)
Concentration type: range
Concentration number: 200/day-400/day
Trade Name: Viread
Product
Sponsors
Enric Pedrol Clotet. Unidad Enfermedades Infecciosas.Hospital de Granollers
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Age ³ 18 years old 2. HIV-1 infected patients 3. Patients on triple HAART therapy with ddI + tenofovir + IP or NNRTI for at least the last 3 months 4. Patients with HIV viral load =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Unable to give informed consent 2.Bad adherence or treatment interruption for the previous 6 months 3.Previous exposure to abacavir 4.HAART therapy including 400 mg ddI + Tenofovir if weight > 60 Kg or ddI 250 mg + Tenofovir if weight < 60 Kg 5.Suspect of crossed resistance to abacavir and lamivudine 6.Abnormal hepatic, pancreatic or other else that make advisable not to include the patient 7.Presence of opportunistic infection and / or recent tumoration 8.Patients on another clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the immunological response during the 48 weeks of the study;Secondary Objective: To evaluate the virological response To evaluate the tolerability and safety;Primary end point(s): CD4 cell count | — |
Countries
Spain
Outcome results
None listed