ATAZANAVIR (BMS-232632) FOR THE TREATMENT OF PATIENTS INFECTED WITH HIV WHO COMPLETED THE CLINICAL TRIALS WITH ATAZANAVIR: A STUDY OF EXTENDED ACCESS.

Not Applicable

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

• Registration Number: PER-069-02
• Lead Sponsor: BRISTOL MYERS SQUIBB PERU S.A.,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2002-11-20
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

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

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br>Outcome name:it is not pertinent<br>Measure:it is not pertinent<br>Timepoints:it is not pertinent<br>

Secondary Outcome Measures

Name	Time	Method
<br>Outcome name:it is not pertinent<br>Measure:it is not pertinent<br>Timepoints:it is not pertinent<br>