PER-008-08已完成未知
Atazanavir (BMS-232632) for HIV Infected Individuals Completing Atazanavir Clinical Trials: An Extended Access Study
BRISTOL MYERS SQUIBB PERU S.A.,0 个研究点目标入组 70 人开始时间: 2008年2月26日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 70
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 0 至 0（—）
入选标准
- •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 <10,000 copies / ml, while they are under therapy.
- •Subjects who are receiving antiretroviral agents in research through Extended Access Programs may participate after the case is discussed and approved by the BMS Medical Monitor.
- •Men and women> 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.
排除标准
- •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.
研究者
相似试验
已完成
3 期
Roll-Over Protocol To Provide Atv And/Or Truvada For Extended AccessHIVNCT01003990Bristol-Myers Squibb710
No Longer Available
不适用
Atazanavir for HIV Infected Individuals: An Early Access ProgramHIV InfectionsNCT00046345Bristol-Myers Squibb
已完成
不适用
Atazanavir for HIV Infected Individuals: An Early Access Program-B24 Unspecified human immunodeficiency virus [HIV] diseaseUnspecified human immunodeficiency virus [HIV] diseaseB24PER-052-03BRISTOL MYERS SQUIBB COMPANY,
进行中（未招募）
不适用
Efficacy of atazanavir/ritonavir monotherapy as maintenance in patients with viral suppression. Randomized, open label non inferiority trial. (MODAt STUDY) - NDEUCTR2010-020442-10-ITFONDAZIONE CENTRO S. RAFFAELE DEL MONTE TABOR
进行中（未招募）
1 期
Pharmacocinétique de l’atazanavir chez des patients infectés par le VIH, traités en première ligne par l’association atazanavir+ritonavir et emtricitabine+ténofovir en prise unique. - COPHAR-3EUCTR2007-003203-12-FRAgence nationale de recherches sur le sida et les hépatites virales. ANRS