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

Study Overview
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Brief Summary
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The purpose of this study is to provide atazanavir or tenofovir-emtricitabine to HIV-infected subjects who have completed atazanavir or tenofovir-emtricitabine therapy on a previous BMS sponsored clinical trial and to collect long-term safety information on the treated population.

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

Official Title
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Atazanavir (BMS-232632) for HIV Infected Individuals Completing Atazanavir Clinical Trials: An Extended Access Study

Conditions
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HIV

Intervention / Treatment
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* Drug: Atazanavir
* Drug: Atazanavir/Ritonavir
* Drug: Tenofovir/Emtricitabine
* Drug: Lopinavir/ritonavir


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Atazanavir<br> | Drug: Atazanavir<br>* Tablets, Oral, 400 mg, once daily, indefinitely<br>* Other names: BMS-232632;|
| Experimental: Atazanavir/Ritonavir<br> | Drug: Atazanavir/Ritonavir<br>* Tablets, Oral, 300/100 mg, once daily, indefinitely<br>* Other names: BMS-232632;|
| Active Comparator: Lopinavir/Ritonavir<br>Ritonavir-boosted Lopinavir (LPV/RTV 400/100 mg) administered twice a day (BID) with Tenofovir/ Emtricitabine (TDF/FTC). | Drug: Tenofovir/Emtricitabine<br>* Tablets, Oral, 300/200 mg, once daily, indefinitely<br>* Other names: Truvada;Drug: Lopinavir/ritonavir<br>* Tablets, Oral, 400/100 mg, twice daily, indefinitely<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Serious Adverse Events (SAEs), Treatment Related SAEs, Treatment Related Adverse Events (AEs), AEs Leading to Discontinuation of Study Therapy, Grade 3 to Grade 4 AEs, Grade 3 to Grade 4 AEs, CDC Class C AIDS Events, or Death | AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or missing relationship to study drug. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4= Potentially Life-threatening or disabling. AIDS Defining Diagnosis ( CDC Class C AIDS Events) are identified from HIV Related Diagnosis. | Date of First Dose to 30 days post the last dose; approximately 405 weeks) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Treatment experienced