None listed
Conditions
Interventions
Ritonavir Type of group
400 mg of ABT-378/100 mg of ritonavir (3 capsules co-formulated) twice daily with meals or 533 mg of ABT-378/133 mg of ritonavir (4 co-formulated capsules) twice daily with the foods
Sponsors
ABBOTT LABORATORIOS S.A.,
Eligibility
Inclusion criteria
Inclusion criteria: • The patient has confirmed his desire to participate in the present study after being informed about all aspects of the study that are relevant to his decision to participate, signing and dating an approved informed consent form. • The patient has a laboratory-confirmed diagnosis of HIV infection (positive HIV ELISA antibody test confirmed by Western blot, p24 antigen test, quantitative HIV-1 RNA assay, or HIV culture). • The patient is> 12 years of age (18 years of age or older when required by the application agencies). Patients between 12 and 18 years of age must have the consent of the parent or legal guardian. • The patient is medically stable according to the opinion of the researcher. • The patient does not require and agree not to take any of the following medications with treatment with ABT-378 / r: midazolam, triazolam, terfenadine, astemizole, cisapride, pimozide, anti-migraine rye ergot derivatives (orgotamine, dihydroergotamine), rifampicin. , St. John´s wort, lovastatin and simvastatin. • The investigator can not elaborate a viable regimen with the available drugs for treatment based on current treatment standards and the prior use of antiretroviral agents by the patient. Enrollment in the study should be considered only for those patients who do not obtain a sustained benefit using the treatment currently available. • The patient has a negative pregnancy test (only women of reproductive age) before treatment with ABT-378 / r. • The patient agrees to use an effective contraceptive method (barrier method) while receiving treatment with ABT-378 / r.
Exclusion criteria
Exclusion criteria: • Pregnant or lactating women. • The patient has liver dysfunction as indicated by the result of a liver function test (AST or ALT) greater than five (5) times the upper limit of normal. • The patient is participating in an existing clinical trial with ABT-378 / r.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Safety and tolerability will be evaluated through the monitoring of serious adverse events. Measure:Safety and tolerability Timepoints:Serious adverse experiences / events should be reported within 24 hours of having occurred throughout the study. | — |
Outcome results
None listed