Ensayo para evaluar la eficacia, seguridad y tolerabilidad, de una estrategia de simplificacion temprana a Trizivir, en pacientes con supresion virologica tras tratamiento antiretroviral con Combivir mas Lopinavir/Ritonavir (Kaletra).
- Conditions
- HIV INFECTIO
- Registration Number
- EUCTR2004-002296-16-ES
- Lead Sponsor
- Antonio Antela López
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 142
1. Diagnosed confirmed of HIV infection.
2. age > 18 years
3. Naïve patients to ARVT.
4. CD4 cels < 200 cels /mm3
5. Patient clinically stable.
6. Patient signd up the informed consent form
7. Pregnancy test at time of baseline negative
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. Two barrier contraception methods if childbearing potential for fertil women.
2. Active AIDS as defined by CDC international clasification 1993.
3. Active mediical condition at time of baseline that intarects with the medical status of the patient and tha HIV treatment.
4. Patients with antineoplasic, inmunomodulator or radiotoxic in investigational phase.
5. Patients in present investigational treatment or need it.
6. Alcohol and/or drug abusewich could interfere with study drugs.
7. Netrophile count under 75.000 mg/l or Hemoglobine under 4.65 mmol/L
8. patient who might be prescribed of any nota loowed concomitnt drug
9. Hypersensibility to any excipient of the study drug.
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 eficacy and safety of a simplification strategy with Trizivir after treatment with Combivir & Kaletra.;Secondary Objective: To evaluate the time to therapeutic failure and the inmunological success of the strategy.;Primary end point(s): To evaluate the virological response, safety and tolerability after 48 weeks of Trizivir simplification in patients with virologic supression after 16 weeks treated with Combivir and Kaletra.
- Secondary Outcome Measures
Name Time Method