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

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

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.

Study Overview

• Status: Completed
• Conditions: HIV
• Intervention / Treatment: Drug: Atazanavir; Drug: Atazanavir/Ritonavir; Drug: Tenofovir/Emtricitabine; Drug: Lopinavir/ritonavir

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 710
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, 1181
    • Local Institution
  • Buenos Aires, Argentina, 1155
    • Local Institution
  • Buenos Aires, Argentina, 1650
    • Local Institution
  • Buenos Aires, Argentina, 1202
    • Local Institution
  • Cordoba, Argentina, X5000BJH
    • Local Institution
  • Santa Fe
    • Rosario, Santa Fe, Argentina, 2000
      • Local Institution
• Brazil
  • Rio De Janeiro, Brazil, 21040000
    • Local Institution
  • Sao Paulo, Brazil, 01246
    • Local Institution
  • Parana
    • Curitiba, Parana, Brazil, 80060
      • Local Institution
    • Curitiba, Parana, Brazil, 80240
      • Local Institution
  • Pernambuco
    • Recife, Pernambuco, Brazil, 52052
      • Local Institution
  • Rio De Janeiro
    • Rio De Janeiro - Rj, Rio De Janeiro, Brazil, 22271
      • Local Institution
  • Sao Paulo
    • Campinas, Sao Paulo, Brazil, 13083
      • Local Institution
    • Sao Paulo - Sp, Sao Paulo, Brazil, 01246
      • Local Institution
• Canada
  • Ontario
    • Hamilton, Ontario, Canada, L8S 4J9
      • Local Institution
  • Quebec
    • Montreal, Quebec, Canada, H2L 5B1
      • Local Institution
• Chile
  • Metropolitana
    • Santiago, Metropolitana, Chile
      • Local Institution
    • Santiago De Chile, Metropolitana, Chile
      • Local Institution
• Colombia
  • Cundinamarca
    • Bogota, Cundinamarca, Colombia
      • Local Institution
• Costa Rica
  • Barrio Aranjuez
    • San Jose, Barrio Aranjuez, Costa Rica, 1792
      • Local Institution
• Dominican Republic
  • Santo Domingo, Dominican Republic
    • Local Institution
• France
  • Le Kremlin Bicetre, France, 94275
    • Local Institution
  • Lyon Cedex 02, France, 69288
    • Local Institution
  • Paris, France, 75020
    • Local Institution
  • Paris, France, 75014
    • Local Institution
  • Tourcoing, France, 59208
    • Local Institution
• Guatemala
  • Guatemala, Guatemala
    • Local Institution
  • Guatemala, Guatemala, 01011
    • Local Institution
  • Guatemala, Guatemala, 01016
    • Local Institution
• Hungary
  • Budapest, Hungary, 1097
    • Local Institution
• Indonesia
  • Jakarta, Indonesia, 10430
    • Local Institution
• Italy
  • Milano, Italy, 20127
    • Local Institution
  • Milano, Italy, 20157
    • Local Institution
  • Modena, Italy, 41100
    • Local Institution
  • Roma, Italy, 00185
    • Local Institution
  • Torino, Italy, 10149
    • Local Institution
• Malaysia
  • Kuala Lumpur, Malaysia, 50586
    • Local Institution
  • Kuala Lumpur, Malaysia, 59100
    • Local Institution
• Mexico
  • Distrito Federal
    • Mexico, Distrito Federal, Mexico, 14080
      • Local Institution
    • Mexico, Distrito Federal, Mexico, 03100
      • Local Institution
• Panama
  • Panama, Panama, 4746
    • Local Institution
• Peru
  • Lima, Peru, 1
    • Local Institution
  • Lima, Peru, 31
    • Local Institution
  • Lima, Peru, 13
    • Local Institution
  • Lima, Peru, LIMA 14
    • Local Institution
  • Lima
    • Barranco, Lima, Peru, 4
      • Local Institution
• Portugal
  • Lisbon, Portugal, 1649-035
    • Local Institution
  • Porto, Portugal, 4200-319
    • Local Institution
• Puerto Rico
  • San Juan, Puerto Rico, 00909
    • Clinical Research Puerto Rico, Inc.
  • San Juan, Puerto Rico, 00927
    • V.A. Medical Center
• Russian Federation
  • Moscow, Russian Federation, 111123
    • Local Institution
  • St. Petersburg, Russian Federation, 189635
    • Local Institution
  • St.petersburg, Russian Federation, 193167
    • Local Institution
• Singapore
  • Singapore, Singapore, 308433
    • Local Institution
• South Africa
  • Eastern Cape
    • Port Elizabeth, Eastern Cape, South Africa, 6001
      • Local Institution
  • Free State
    • Bloemfontein, Free State, South Africa, 9301
      • Local Institution
  • Gauteng
    • Johannesburg, Gauteng, South Africa, 2013
      • Local Institution
    • Meadowdale, Gauteng, South Africa, 1610
      • Local Institution
    • Westdene, Gauteng, South Africa, 2092
      • Local Institution
  • Western Cape
    • Observatory, Western Cape, South Africa, 7925
      • Local Institution
    • Rugby, Western Cape, South Africa, 7405
      • Local Institution
• Spain
  • Badalona, Spain, 08915
    • Local Institution
  • Barcelona, Spain, 08036
    • Local Institution
  • Bilbao, Spain, 48013
    • Local Institution
  • Cordoba, Spain, 14004
    • Local Institution
  • Madrid, Spain, 28034
    • Local Institution
  • Madrid, Spain, 28046
    • Local Institution
  • Madrid, Spain, 28040
    • Local Institution
  • Madrid, Spain, 28029
    • Local Institution
  • Sevilla, Spain, 41013
    • Local Institution
• Taiwan
  • Kaohsiung, Taiwan, 813
    • Local Institution
  • Taipei, Taiwan, 100
    • Local Institution
  • Taipei, Taiwan, 108
    • Local Institution
• Thailand
  • Bangkok, Thailand, 10400
    • Local Institution
  • Bangkok, Thailand, 10700
    • Local Institution
  • Bangkok, Thailand, 10300
    • Local Institution
  • Chiangmai, Thailand, 50200
    • Local Institution
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85006
      • Phoenix Body Positive, Inc
  • California
    • Los Angeles, California, United States, 90033
      • Rand Schrader Clinic
    • San Francisco, California, United States, 94109
      • St Francis Memorial Hospital
  • Florida
    • Miami Beach, Florida, United States, 33139
      • Sbma Research, Llc
    • Tampa, Florida, United States, 33607
      • St Josephs Cmprhnsv Rsch Inst
  • Indiana
    • Indianapolis, Indiana, United States, 46218
      • Infectious Disease Of Indiana, Psc
  • Kansas
    • Wichita, Kansas, United States, 67214
      • Univ Of Kansas Sch Of Med
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • CRI of New England
  • Nebraska
    • Omaha, Nebraska, United States, 68198
      • University of Nebraska Medical Center
  • North Carolina
    • Huntersville, North Carolina, United States, 28078
      • Jemsek Clinic
  • Texas
    • Fort Worth, Texas, United States, 76104
      • Tarrant County Inf Dis Assoc
    • Houston, Texas, United States, 77098
      • The Schrader Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• BMS clinical trial educational resource

Study record dates

Study Major Dates

• Study Start: October 1, 2002
• Primary Completion (Actual): February 1, 2016
• Study Completion (Actual): February 1, 2016

Study Registration Dates

• First Submitted: October 20, 2009
• First Submitted That Met QC Criteria: October 28, 2009
• First Posted (Estimate): October 29, 2009

Study Record Updates

• Last Update Posted (Actual): May 11, 2017
• Last Update Submitted That Met QC Criteria: April 4, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: Treatment experienced
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Reverse Transcriptase Inhibitors; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Anti-HIV Agents; Anti-Retroviral Agents; Protease Inhibitors; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; HIV Protease Inhibitors; Viral Protease Inhibitors; Tenofovir; Emtricitabine; Ritonavir; Lopinavir; Atazanavir Sulfate
• Other Study ID Numbers: AI424-077