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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01003990
First received: October 20, 2009
Last updated: August 28, 2014
Last verified: February 2012
  Purpose

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


Condition Intervention Phase
HIV
Drug: Atazanavir
Drug: Atazanavir/Ritonavir
Drug: Tenofovir/Emtricitabine
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Atazanavir (BMS-232632) for HIV Infected Individuals Completing Atazanavir Clinical Trials: An Extended Access Study

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Safety outcome measures will include the frequency and severity of adverse events, treatment-related adverse events, serious adverse events, discontinuation from study due to adverse events, and laboratory abnormalities [ Time Frame: upon occurance, until August 2013 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 306
Study Start Date: October 2002
Estimated Study Completion Date: August 2018
Estimated Primary Completion Date: August 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Atazanavir Drug: Atazanavir
Tablets, Oral, 400 mg, once daily, indefinitely
Other Names:
  • Reyataz
  • BMS-232632
Atazanavir/Ritonavir or Tenofovir/Emtricitabine Drug: Atazanavir/Ritonavir
Tablets, Oral, 300/100 mg, once daily, indefinitely
Other Names:
  • Reyataz
  • BMS-232632
Drug: Tenofovir/Emtricitabine
Tablets, Oral, 300/200 mg, once daily, indefinitely
Other Name: Truvada
Tenofovir/ Emtricitabine Drug: Tenofovir/Emtricitabine
Tablets, Oral, 300/200 mg, once daily, indefinitely
Other Name: Truvada

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   16 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01003990

  Hide Study Locations
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
Argentina
Local Institution
Rosario, Santa Fe, Argentina, 2000
Local Institution
Buenos Aires, Argentina, 1650
Local Institution
Buenos Aires, Argentina, 1202
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Buenos Aires, Argentina, 1155
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Buenos Aires, Argentina, 1181
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Cordoba, Argentina, X5000BJH
Brazil
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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
Local Institution
Montreal, Quebec, Canada, H2L 5B1
Chile
Local Institution
Santiago, Metropolitana, Chile, XXX
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Santiago, Metropolitana, Chile
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Santiago De Chile, Metropolitana, Chile, XXX
Colombia
Local Institution
Bogota, Cundinamarca, Colombia
Costa Rica
Local Institution
San Jose, Barrio Aranjuez, Costa Rica, 1792
Dominican Republic
Local Institution
Santo Domingo, Dominican Republic
France
Local Institution
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
Guatemala
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Guatemala, Guatemala, 01011
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Guatemala, Guatemala, 01016
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Guatemala, Guatemala
Hungary
Local Institution
Budapest, Hungary, 1097
Indonesia
Local Institution
Jakarta, Indonesia, 10430
Italy
Local Institution
Milano, Italy, 20157
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Milano, Italy, 20127
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Modena, Italy, 41100
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Roma, Italy, 00185
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Torino, Italy, 10149
Malaysia
Local Institution
Kuala Lumpur, Malaysia, 59100
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Kuala Lumpur, Malaysia, 50586
Mexico
Local Institution
Mexico, Distrito Federal, Mexico, 14080
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Mexico, Distrito Federal, Mexico, 03100
Panama
Local Institution
Panama, Panama, 4746
Peru
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Barranco, Lima, Peru, 4
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Lima, Peru, 31
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Lima, Peru, 1
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Lima, Peru, 13
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Lima, Peru, LIMA 14
Portugal
Local Institution
Lisbon, Portugal, 1649-035
Local Institution
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
Singapore
Local Institution
Singapore, Singapore, 308433
South Africa
Local Institution
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
Spain
Local Institution
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, 28040
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Madrid, Spain, 28029
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Madrid, Spain, 28034
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Madrid, Spain, 28046
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Sevilla, Spain, 41013
Taiwan
Local Institution
Kaohsiung, Taiwan, 813
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Taipei, Taiwan, 108
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Taipei, Taiwan, 100
Thailand
Local Institution
Bangkok, Thailand, 10300
Local Institution
Bangkok, Thailand, 10400
Local Institution
Bangkok, Thailand, 10700
Local Institution
Chiangmai, Thailand, 50200
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01003990     History of Changes
Other Study ID Numbers: AI424-077
Study First Received: October 20, 2009
Last Updated: August 28, 2014
Health Authority: Brazil: National Health Surveillance Agency
Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos
Costa Rica: Ministry of Health Costa Rica
Dominican Republic: Ministry of Public Health and Social Assistance
Guatemala: Ministry of Public Health and Social Assistance
Indonesia: Departement Kesehatan (Department of Health)
Panama: Ministry of Health
Peru: Instituto Nacional de Salud
Singapore: Ministry of Health
Taiwan: Department of Health
United States: Food and Drug Administration

Keywords provided by Bristol-Myers Squibb:
Treatment experienced

Additional relevant MeSH terms:
Ritonavir
Atazanavir
Tenofovir
Tenofovir disoproxil
Emtricitabine
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on August 28, 2014