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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01003990
First received: October 20, 2009
Last updated: April 4, 2017
Last verified: April 2017
October 20, 2009
April 4, 2017
October 2002
February 2016   (Final data collection date for primary outcome measure)
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.
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 ]
Complete list of historical versions of study NCT01003990 on ClinicalTrials.gov Archive Site
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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.
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
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Other
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
  • Drug: Lopinavir/ritonavir
    Tablets, Oral, 400/100 mg, twice daily, indefinitely
  • Experimental: Atazanavir
    Intervention: Drug: Atazanavir
  • Experimental: Atazanavir/Ritonavir
    Intervention: Drug: Atazanavir/Ritonavir
  • Active Comparator: Lopinavir/Ritonavir
    Ritonavir-boosted Lopinavir (LPV/RTV 400/100 mg) administered twice a day (BID) with Tenofovir/ Emtricitabine (TDF/FTC).
    Interventions:
    • Drug: Tenofovir/Emtricitabine
    • Drug: Lopinavir/ritonavir
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
710
February 2016
February 2016   (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
Sexes Eligible for Study: All
16 Years and older   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
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,   United States
Poland
 
NCT01003990
AI424-077
No
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Bristol-Myers Squibb
Bristol-Myers Squibb
Not Provided
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
April 2017

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