Atazanavir for HIV Infected Individuals: An Early Access Program

Not Applicable

• Conditions: -B24 Unspecified human immunodeficiency virus [HIV] disease; Unspecified human immunodeficiency virus [HIV] disease; B24

• Registration Number: PER-052-03
• Lead Sponsor: BRISTOL MYERS SQUIBB COMPANY,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2003-09-30
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Not specified
• Target Recruitment: 0

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

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).

Study & Design

• Study Type: Interventional
• Study Design: Not specified