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 11, 2014
Last verified: February 2012

October 20, 2009
August 11, 2014
October 2002
August 2018   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01003990 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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

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

Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
HIV
  • Drug: Atazanavir
    Tablets, Oral, 400 mg, once daily, indefinitely
    Other Names:
    • Reyataz
    • BMS-232632
  • 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
  • Atazanavir
    Intervention: Drug: Atazanavir
  • Atazanavir/Ritonavir or Tenofovir/Emtricitabine
    Interventions:
    • Drug: Atazanavir/Ritonavir
    • Drug: Tenofovir/Emtricitabine
  • Tenofovir/ Emtricitabine
    Intervention: Drug: Tenofovir/Emtricitabine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
306
August 2018
August 2018   (final data collection date for primary outcome measure)

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
Both
16 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Argentina,   Brazil,   Canada,   Chile,   Colombia,   Costa Rica,   Dominican Republic,   France,   Guatemala,   Hungary,   Indonesia,   Italy,   Malaysia,   Mexico,   Panama,   Peru,   Portugal,   Puerto Rico,   Russian Federation,   Singapore,   South Africa,   Spain,   Taiwan,   Thailand
 
NCT01003990
AI424-077
No
Bristol-Myers Squibb
Bristol-Myers Squibb
Not Provided
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP