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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01003990
Recruitment Status : Completed
First Posted : October 29, 2009
Results First Posted : May 11, 2017
Last Update Posted : May 11, 2017
Information provided by (Responsible Party):
Bristol-Myers Squibb

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
HIV Drug: Atazanavir Drug: Atazanavir/Ritonavir Drug: Tenofovir/Emtricitabine Drug: Lopinavir/ritonavir Phase 3

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  (Clinical Trial)
Actual Enrollment : 710 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Atazanavir (BMS-232632) for HIV Infected Individuals Completing Atazanavir Clinical Trials: An Extended Access Study
Study Start Date : October 2002
Actual Primary Completion Date : February 2016
Actual Study Completion Date : February 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

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 Name: Truvada

Drug: Lopinavir/ritonavir
Tablets, Oral, 400/100 mg, twice daily, indefinitely

Primary Outcome Measures :
  1. 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 [ Time Frame: Date of First Dose to 30 days post the last dose; approximately 405 weeks) ]
    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.

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01003990

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

Additional Information:
Responsible Party: Bristol-Myers Squibb Identifier: NCT01003990     History of Changes
Other Study ID Numbers: AI424-077
First Posted: October 29, 2009    Key Record Dates
Results First Posted: May 11, 2017
Last Update Posted: May 11, 2017
Last Verified: April 2017

Keywords provided by Bristol-Myers Squibb:
Treatment experienced

Additional relevant MeSH terms:
Atazanavir Sulfate
Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors