None listed
Conditions
Interventions
BMS-232632 (ATAZANAVIR) Type of group
You will be given 400 mg of atazanavir once a day along with your food intake. Atazanavir should be administered in combination with two or more additional antiretroviral agents, which will be determined by the physician in charge of the patient.
Sponsors
BRISTOL MYERS SQUIBB PERU S.A.,
Eligibility
Inclusion criteria
Inclusion criteria: Currently receiving atazanavir (unboosted or boosted with 100 mg ritonavir QD)and/or tenofovir-emtricitabine at time of screening and viral load is ≤ 10,000 copies/mL while on therapy Subjects who are receiving investigational antiretroviral agents through Expanded Access Programs will be allowed to participate following discussion and approval by the BMS Medical Monitor ≥ 16 years of age (or minimum age as determined by local regulatory or as legal requirements dictate) Both females of child-bearing potential and males must utilize effective barrier contraception to reduce transmission of sexually transmitted diseases, including HIV. Other contraception in addition to barrier methods are permitted, however interactions between atazanavir and oral contraceptives have not been studied
Exclusion criteria
Exclusion criteria: WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 8 weeks after the study WOCBP using a prohibited contraceptive method (no contraceptive methods prohibited in this study. However, caution is warranted with coadministration of oral contraceptives) Women who are pregnant or breastfeeding Women with a positive pregnancy test on enrollment or prior to study drug administration, with the exception of women rolling over from AI424182, who may still have a positive β-HCG test at the time of enrollment All subjects previously discontinued from an atazanavir study for any reason Active alcohol or substance abuse sufficient, in the Investigator´s opinion, to prevent adequate compliance with study therapy or to increase the risk of developing pancreatitis or chemical hepatitis Any other clinical conditions or prior therapy that, in the opinion of the investigator, would make the subject unsuitable for study, or unable to comply with the dosing 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 component of the formulation of study drug Refer to Section 6.4.1 which details all prohibited therapies Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g., infectious disease) illness must not be enrolled into this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:it is not pertinent Measure:it is not pertinent Timepoints:it is not pertinent | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:it is not pertinent Measure:it is not pertinent Timepoints:it is not pertinent | — |
Countries
Argentina, Brazil, Canada, Chile, Colombia, Costa Rica, Dominican Republic, France, Guatemala, Hungary, Indonesia, Italy, Malasya, Mexico, Panama, Peru, Portugal, Puerto Rico, Russian Federation, Singapore, South Africa, Spain, Taiwan, Thailand, United States
Outcome results
None listed