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

HIV Clinical Trial

Official title:

Atazanavir (BMS-232632) for HIV Infected Individuals Completing Atazanavir Clinical Trials: An Extended Access Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01003990
• Other study ID #: AI424-077
• Status: Completed
• Phase: Phase 3
• First received: October 20, 2009
• Last updated: January 5, 2017
• Start date: October 2002
• Est. completion date: February 2016

Study information

• Verified date: April 2016
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Health Surveillance AgencyColombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y AlimentosCosta Rica: Ministry of Health Costa RicaDominican Republic: Ministry of Public Health and Social AssistanceGuatemala: Ministry of Public Health and Social AssistanceIndonesia: Departement Kesehatan (Department of Health)Panama: Ministry of HealthPeru: Instituto Nacional de SaludSingapore: Ministry of HealthTaiwan: Department of HealthUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 709
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 75 Years

Eligibility

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 ß-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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• HIV

Intervention

Drug:
• Atazanavir
Tablets, Oral, 400 mg, once daily, indefinitely
• Atazanavir/Ritonavir
Tablets, Oral, 300/100 mg, once daily, indefinitely
• Tenofovir/Emtricitabine
Tablets, Oral, 300/200 mg, once daily, indefinitely

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

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, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		upon occurance, until August 2013	Yes

External Links

•   BMS clinical trial educational resource
•   BMS Clinical Trial Information
•   FDA Safety Alerts and Recalls
•   Investigator Inquiry form