Roll-Over Protocol To Provide Atv And/Or Truvada For Extended Access

Recruitment & Eligibility

Status: Complete

Sex: Not specified

Target Recruitment: 70

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 <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.

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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