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: September 15, 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

  Show 90 Study Locations
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: September 15, 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 September 15, 2014