HIV INFECTION
Conditions
Interventions
Trade Name: KALETRA
Product Name: KALETRA
Product Code: KALETRA
Pharmaceutical Form: Capsule, soft
INN or Proposed INN: Lopinavir
Current Sponsor code: Lopinavir
Other descriptive name: ABT-378
Concen
Sponsors
Antonio Antela López
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Diagnosed confirmed of HIV infection. 2. age > 18 years 3. Naïve patients to ARVT. 4. CD4 cels =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Spain
Outcome results
None listed