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

Provide study drug for patients rolling off BMS ATV clinical trials in countries where these
medications are not commercially available.

Inclusion Criteria:

- Subjects must provide written informed consent

- 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