ESTUDIO DE LOS CAMBIOS EN EL RECUENTO DE LINFOCITOS CD4 TRAS LA SUSTITUCIÓN DE TENOFOVIR POR ABACAVIR EN PACIENTES CON UNA PAUTA HAART QUE INCLUYA DDI + TENOFOVIR Y CON SUPRESIÓN VIRA
- Conditions
- HIV infected patients
- Registration Number
- EUCTR2004-003749-42-ES
- Lead Sponsor
- Enric Pedrol Clotet. Unidad Enfermedades Infecciosas.Hospital de Granollers
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
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 < 50 copy / ml for at least 6 months
5. Not being on treatment with immunosuppressors such as: hidroxiurea, interferon, ribavirina or cytostatic.
6. Not being on treatment with interleukine-2 or other immunomodulator
7. If female, not to be childbed potential or should use a anticonceptive method during the study
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) yes
F.1.3.1 Number of subjects for this age range
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the immunological response during the 48 weeks of the study;Secondary Objective: To evaluate the virological response<br>To evaluate the tolerability and safety;Primary end point(s): CD4 cell count
- Secondary Outcome Measures
Name Time Method