None listed
Conditions
Interventions
Atazanavir Type of group
Each patient will receive 400 mg of atazanavir once a day with meals in combination with 2 or more antiretroviral agents, whose selection will be determined by the patient is medical provider.
Sponsors
BRISTOL MYERS SQUIBB COMPANY,
Eligibility
Inclusion criteria
Inclusion criteria: 1) Treatment failure, defined as resistance to ARV therapy, metabolic abnormalities (for example, hypercholesterolemia, hyperglyceridemia) or another problem of intolerance or of attachment and disability of the patient. to structure an effective alternative HAART regimen using other ARV agents available. 2) be over 16 years of age (or the minimum age determined by local regulations or legal requirements). 3) Negative pregnancy test for women with ability to conceive. 4) Both women with the ability to conceive and men must Use an effective barrier method of contraception. 5) Patients must provide their informed consent in writing. 6) Baseline laboratory values measured in the 2 weeks prior to the administration of the study drugs should be normal (serum creatinine, liver enzymes (AST, ALT) and total serum bilirubin)
Exclusion criteria
Exclusion criteria: 1) Pregnant or lactating women. 2) Active abuse of alcohol or substances sufficient, in the opinion of the Investigator, to prevent adequate adherence to the study treatment or to increase the risk of developing pancreatitis or chemical hepatitis. 3) Concomitant use of contraindicated medications (eg, rifampin, St. John´s wort, certain drugs that are substrates of CYP3A4 at narrow therapeutic intervals) 4) Presence of cardiomyopathy (due to any cause) or of any significant cardiovascular disease, such as unstable ischemic heart disease. 5) Known antecedents of QTc interval prolongation (e.g. induced by medications, congenital or for other causes).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:The frequency and severity of adverse events and serious adverse events (clinical and laboratory). Measure:Make atazanavir available to HIV-infected patients who have shown virological failure with available antiretroviral treatment options and who do not have the possibility of building an effective alternative treatment regimen, using the antiretroviral agents that currently exist, due to a previous virological failure, intolerance to the drug or adhesion problems. Timepoints:Subjects return in weeks 4, 8, 12 and then every 12 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:The change in plasmatic HIV RNA over the course of. time, expressed in log10 c / mL. The proportion of subjects with a reduction> 1.0 log10 with respect to the baseline in plasma HIV RNA levels or with an HIV RNA level below the Quantification Level (NDC = 400 c / mL or 50 c / mL). The change in CD4 cell counts relative to the baseline. Measure:Collect safety information on the use of atazanavir in this population with experience with antiretrovirals. Timepoints:Subjects return in weeks 4, 8, 12 and then every 12 weeks | — |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Colombia, Croatia, Czech Republic, Denmark, Ecuador, Finland, France, Greece, Honduras, Hungary, Israel, Italy, Japan, Lebano, Luxembourg, Malasya, Mexico, Netherlands, Norway, Peru, Poland, Puerto Rico, Romania, Russian Federation, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Ukraine, United Kindgdom, United States, Uruguay, Venezuela
Outcome results
None listed