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

Information source: Bristol-Myers Squibb
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: HIV

Intervention: Atazanavir (Drug); Atazanavir/Ritonavir (Drug); Tenofovir/Emtricitabine (Drug)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: Bristol-Myers Squibb

Official(s) and/or principal investigator(s):
Bristol-Myers Squibb, Study Director, Affiliation: Bristol-Myers Squibb

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

Clinical Details

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

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

Primary outcome: 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

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

Eligibility

Minimum age: 16 Years. Maximum age: 75 Years. Gender(s): Both.

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

Locations and Contacts

Local Institution, Buenos Aires 1650, Argentina

Local Institution, Buenos Aires 1181, Argentina

Local Institution, Buenos Aires 1202, Argentina

Local Institution, Buenos Aires 1155, Argentina

Local Institution, Cordoba X5000BJH, Argentina

Local Institution, Rio De Janeiro 21040000, Brazil

Local Institution, Sao Paulo 01246, Brazil

Local Institution, Santo Domingo, Dominican Republic

Local Institution, Le Kremlin Bicetre 94275, France

Local Institution, Lyon Cedex 02 69288, France

Local Institution, Paris 75014, France

Local Institution, Paris 75020, France

Local Institution, Tourcoing 59208, France

Local Institution, Guatemala 01016, Guatemala

Local Institution, Guatemala, Guatemala

Local Institution, Guatemala 01011, Guatemala

Local Institution, Budapest 1097, Hungary

Local Institution, Jakarta 10430, Indonesia

Local Institution, Milano 20127, Italy

Local Institution, Milano 20157, Italy

Local Institution, Modena 41100, Italy

Local Institution, Roma 00185, Italy

Local Institution, Torino 10149, Italy

Local Institution, Kuala Lumpur 50586, Malaysia

Local Institution, Kuala Lumpur 59100, Malaysia

Local Institution, Panama 4746, Panama

Local Institution, Lima 13, Peru

Local Institution, Lima 1, Peru

Local Institution, Lima 31, Peru

Local Institution, Lima LIMA 14, Peru

Local Institution, Lisbon 1649-035, Portugal

Local Institution, Porto 4200-319, Portugal

Clinical Research Puerto Rico, Inc., San Juan 00909, Puerto Rico

V.A. Medical Center, San Juan 00927, Puerto Rico

Local Institution, Moscow 111123, Russian Federation

Local Institution, St. Petersburg 189635, Russian Federation

Local Institution, St.petersburg 193167, Russian Federation

Local Institution, Singapore 308433, Singapore

Local Institution, Badalona 08915, Spain

Local Institution, Barcelona 08036, Spain

Local Institution, Bilbao 48013, Spain

Local Institution, Cordoba 14004, Spain

Local Institution, Madrid 28029, Spain

Local Institution, Madrid 28034, Spain

Local Institution, Madrid 28040, Spain

Local Institution, Madrid 28046, Spain

Local Institution, Sevilla 41013, Spain

Local Institution, Kaohsiung 813, Taiwan

Local Institution, Taipei 100, Taiwan

Local Institution, Taipei 108, Taiwan

Local Institution, Bangkok 10300, Thailand

Local Institution, Bangkok 10400, Thailand

Local Institution, Bangkok 10700, Thailand

Local Institution, Chiangmai 50200, Thailand

Phoenix Body Positive, Inc, Phoenix, Arizona 85006, United States

Local Institution, San Jose, Barrio Aranjuez 1792, Costa Rica

Rand Schrader Clinic, Los Angeles, California 90033, United States

St Francis Memorial Hospital, San Francisco, California 94109, United States

Local Institution, Bogota, Cundinamarca, Colombia

Local Institution, Mexico, Distrito Federal 03100, Mexico

Local Institution, Mexico, Distrito Federal 14080, Mexico

Local Institution, Port Elizabeth, Eastern Cape 6001, South Africa

Sbma Research, Llc, Miami Beach, Florida 33139, United States

St Josephs Cmprhnsv Rsch Inst, Tampa, Florida 33607, United States

Local Institution, Bloemfontein, Free State 9301, South Africa

Local Institution, Johannesburg, Gauteng 2013, South Africa

Local Institution, Meadowdale, Gauteng 1610, South Africa

Local Institution, Westdene, Gauteng 2092, South Africa

Infectious Disease Of Indiana, Psc, Indianapolis, Indiana 46218, United States

Univ Of Kansas Sch Of Med, Wichita, Kansas 67214, United States

Local Institution, Barranco, Lima 4, Peru

Cri Of New England, Boston, Massachusetts 02215, United States

Local Institution, Santiago De Chile, Metropolitana XXX, Chile

Local Institution, Santiago, Metropolitana XXX, Chile

Local Institution, Santiago, Metropolitana, Chile

University Of Nebraska Medical Center, Omaha, Nebraska 68198, United States

Jemsek Clinic, Huntersville, North Carolina 28078, United States

Local Institution, Hamilton, Ontario L8S 4J9, Canada

Local Institution, Curitiba, Parana 80060, Brazil

Local Institution, Curitiba, Parana 80240, Brazil

Local Institution, Recife, Pernambuco 52052, Brazil

Local Institution, Montreal, Quebec H2L 5B1, Canada

Local Institution, Rio De Janeiro - Rj, Rio De Janeiro 22271, Brazil

Local Institution, Rosario, Santa Fe 2000, Argentina

Local Institution, Campinas, Sao Paulo 13083, Brazil

Local Institution, Sao Paulo - Sp, Sao Paulo 01246, Brazil

Tarrant County Inf Dis Assoc, Fort Worth, Texas 76104, United States

The Schrader Clinic, Houston, Texas 77098, United States

Local Institution, Observatory, Western Cape 7925, South Africa

Local Institution, Rugby, Western Cape 7405, South Africa

Additional Information

BMS Clinical Trial Information

BMS clinical trial educational resource

Investigator Inquiry form

FDA Safety Alerts and Recalls

Starting date: October 2002
Last updated: August 19, 2015

Page last updated: August 23, 2015

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