Clinical trial NCT01003990: Roll-Over Protocol To Provide Atv And/Or Truvada For Extended Access
Official title: Atazanavir (BMS-232632) for HIV Infected Individuals Completing Atazanavir Clinical Trials: An Extended Access Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: HIV
Keywords: Treatment experienced
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2009-10-29
Enrollment: 710
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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

Eligibility 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

Primary outcomes:
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
timeFrame: Date of First Dose to 30 days post the last dose; approximately 405 weeks)
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Phoenix Body Positive, Inc
state: Arizona
city: Los Angeles
country: United States
facility: Rand Schrader Clinic
state: California
city: San Francisco
country: United States
facility: St Francis Memorial Hospital
state: California
city: Miami Beach
country: United States
facility: Sbma Research, Llc
state: Florida
city: Tampa
country: United States
facility: St Josephs Cmprhnsv Rsch Inst
state: Florida
city: Indianapolis
country: United States
facility: Infectious Disease Of Indiana, Psc
state: Indiana
city: Wichita
country: United States
facility: Univ Of Kansas Sch Of Med
state: Kansas
city: Boston
country: United States
facility: Cri Of New England
state: Massachusetts
city: Omaha
country: United States
facility: University Of Nebraska Medical Center
state: Nebraska
city: Huntersville
country: United States
facility: Jemsek Clinic
state: North Carolina
city: Fort Worth
country: United States
facility: Tarrant County Inf Dis Assoc
state: Texas
city: Houston
country: United States
facility: The Schrader Clinic
state: Texas
city: Rosario
country: Argentina
facility: Local Institution
state: Santa Fe
city: Buenos Aires
country: Argentina
facility: Local Institution
city: Buenos Aires
country: Argentina
facility: Local Institution
city: Buenos Aires
country: Argentina
facility: Local Institution
city: Buenos Aires
country: Argentina
facility: Local Institution
city: Cordoba
country: Argentina
facility: Local Institution
city: Curitiba
country: Brazil
facility: Local Institution
state: Parana
city: Curitiba
country: Brazil
facility: Local Institution
state: Parana
city: Recife
country: Brazil
facility: Local Institution
state: Pernambuco
city: Rio De Janeiro - Rj
country: Brazil
facility: Local Institution
state: Rio De Janeiro
city: Campinas
country: Brazil
facility: Local Institution
state: Sao Paulo
city: Sao Paulo - Sp
country: Brazil
facility: Local Institution
state: Sao Paulo
city: Rio De Janeiro
country: Brazil
facility: Local Institution
city: Sao Paulo
country: Brazil
facility: Local Institution
city: Hamilton
country: Canada
facility: Local Institution
state: Ontario
city: Montreal
country: Canada
facility: Local Institution
state: Quebec
city: Santiago De Chile
country: Chile
facility: Local Institution
state: Metropolitana
city: Santiago
country: Chile
facility: Local Institution
state: Metropolitana
city: Bogota
country: Colombia
facility: Local Institution
state: Cundinamarca
city: San Jose
country: Costa Rica
facility: Local Institution
state: Barrio Aranjuez
city: Santo Domingo
country: Dominican Republic
facility: Local Institution
city: Le Kremlin Bicetre
country: France
facility: Local Institution
city: Lyon Cedex 02
country: France
facility: Local Institution
city: Paris
country: France
facility: Local Institution
city: Paris
country: France
facility: Local Institution
city: Tourcoing
country: France
facility: Local Institution
city: Guatemala
country: Guatemala
facility: Local Institution
city: Guatemala
country: Guatemala
facility: Local Institution
city: Guatemala
country: Guatemala
facility: Local Institution
city: Budapest
country: Hungary
facility: Local Institution
city: Jakarta
country: Indonesia
facility: Local Institution
city: Milano
country: Italy
facility: Local Institution
city: Milano
country: Italy
facility: Local Institution
city: Modena
country: Italy
facility: Local Institution
city: Roma
country: Italy
facility: Local Institution
city: Torino
country: Italy
facility: Local Institution
city: Kuala Lumpur
country: Malaysia
facility: Local Institution
city: Kuala Lumpur
country: Malaysia
facility: Local Institution
city: Mexico
country: Mexico
facility: Local Institution
state: Distrito Federal
city: Mexico
country: Mexico
facility: Local Institution
state: Distrito Federal
city: Panama
country: Panama
facility: Local Institution
city: Barranco
country: Peru
facility: Local Institution
state: Lima
city: Lima
country: Peru
facility: Local Institution
city: Lima
country: Peru
facility: Local Institution
city: Lima
country: Peru
facility: Local Institution
city: Lima
country: Peru
facility: Local Institution
city: Lisbon
country: Portugal
facility: Local Institution
city: Porto
country: Portugal
facility: Local Institution
city: San Juan
country: Puerto Rico
facility: Clinical Research Puerto Rico, Inc.
city: San Juan
country: Puerto Rico
facility: V.A. Medical Center
city: Moscow
country: Russian Federation
facility: Local Institution
city: St. Petersburg
country: Russian Federation
facility: Local Institution
city: St.petersburg
country: Russian Federation
facility: Local Institution
city: Singapore
country: Singapore
facility: Local Institution
city: Port Elizabeth
country: South Africa
facility: Local Institution
state: Eastern Cape
city: Bloemfontein
country: South Africa
facility: Local Institution
state: Free State
city: Johannesburg
country: South Africa
facility: Local Institution
state: Gauteng
city: Meadowdale
country: South Africa
facility: Local Institution
state: Gauteng
city: Westdene
country: South Africa
facility: Local Institution
state: Gauteng
city: Observatory
country: South Africa
facility: Local Institution
state: Western Cape
city: Rugby
country: South Africa
facility: Local Institution
state: Western Cape
city: Badalona
country: Spain
facility: Local Institution
city: Barcelona
country: Spain
facility: Local Institution
city: Bilbao
country: Spain
facility: Local Institution
city: Cordoba
country: Spain
facility: Local Institution
city: Madrid
country: Spain
facility: Local Institution
city: Madrid
country: Spain
facility: Local Institution
city: Madrid
country: Spain
facility: Local Institution
city: Madrid
country: Spain
facility: Local Institution
city: Sevilla
country: Spain
facility: Local Institution
city: Kaohsiung
country: Taiwan
facility: Local Institution
city: Taipei
country: Taiwan
facility: Local Institution
city: Taipei
country: Taiwan
facility: Local Institution
city: Bangkok
country: Thailand
facility: Local Institution
city: Bangkok
country: Thailand
facility: Local Institution
city: Bangkok
country: Thailand
facility: Local Institution
city: Chiangmai
country: Thailand
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: