None listed
Conditions
Interventions
Therapy Type of group
400 mg of atazanavir QD or 300 mg of atazanavir QD (if combined with RTV), (2 capsules of 200 mg, 3 capsules of 100 mg or 2 capsules of 150 mg) and / or tenofovir-emtricitabine (one tablet QD, 300 mg - 200 mg).
Sponsors
BRISTOL MYERS SQUIBB PERU S.A.,
Eligibility
Inclusion criteria
Inclusion criteria: • Subjects must provide written informed consent; • Patients currently receiving atazanavir (reinforced or not with 100 mg of ritonavir QD) and / or tenofovir-emtricitabine at the time of selection and whose viral load is 16 years (or the minimum age determined by local regulatory authorities or by legal requirements). • Both women of childbearing age (MEF), as well as male patients, should use a proven barrier contraceptive method to reduce the spread of sexually transmitted diseases, including HIV. Other contraceptive methods are allowed in addition to barrier methods; however, the interactions between atazanavir and oral contraceptives have not been studied to date.
Exclusion criteria
Exclusion criteria: • Potentially fertile women who are unwilling or unable to use a method of birth control that is acceptable throughout the study and for a period of up to 8 weeks after the end of the study. • Potentially fertile women who are using a prohibited contraceptive method (contraceptive methods prohibited in this study are not included) However, caution is advised when co-administering oral contraceptives • Pregnant or lactating women. • Women who have obtained a positive result in the pregnancy test performed during the enrollment or before the administration of the study drug, except for women who continue to come from AI424182, who may still obtain a positive test result of the jS-HCG when included in the study. • All patients who have been previously discontinued from an atazanavir study for any reason. • Active abuse of alcohol or substances that, in the opinion of the Investigator, were a sufficient reason to prevent adequate compliance with the therapy under study, or that could increase the risk of developing pancreatitis or pharmacological hepatitis. • Any other clinical condition or previous therapy that, in the opinion of the Investigator, made the patient unfit to continue in the study, or unable to comply with the treatment requirements. • Any of the following laboratory values: a) serum creatinine> 1.5 times the upper limit of normal, b) liver enzymes (AST, ALT)> 5 times the upper limit of normal, • Hypersensitivity to any of the excipients of the study medication. • See Section 6.4.1 where all prohibited therapies are listed. • Prisoners or subjects who are deprived of their freedom (involuntarily detained) for the treatment of a psychiatric or physical illness (eg, infectious disease) may not be enrolled in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Safety assessments will be based on the set of data collected and combined. Safety tabulations will include the time of treatment with atazanavir and / or tenofoviremtricitabine, the frequency of category C events related to AIDS according to the CDC, adverse events, serious adverse events, deaths, laboratory abnormalities, and discontinuations of treatment. Measure:Safety Timepoints:Week 16, and then every 12 weeks | — |
Countries
Argentina, Brazil, Canada, Chile, Colombia, Costa Rica, Dominican Republic, France, Guatemala, Hungary, Indonesia, Italy, Malasya, Mexico, Panama, Peru, Poland, Portugal, Puerto Rico, Russian Federation, Singapore, South Africa, Spain, Taiwan, Thailand, United States
Contacts
Public ContactUrsula Noto
BRISTOL MYERS SQUIBB PERU S.A.
Outcome results
None listed