Clinical Trial: Rollover Study for Zerit (Stavudine) ER Studies (-096, -099)

This study has been completed.

Sponsored by: Bristol-Myers Squibb
Information provided by: Bristol-Myers Squibb


The purpose of this study is to compare long-term safety and tolerability of stavudine (d4T) extended release (ER) versus conventional (immediate release [IR]) formulations, each in combination with lamivudine (3TC) and efavirenz (EFV) in subjects who have completed Bristol-Myers Squibb (BMS) studies AI455-096 and AI455-099.
Condition Intervention Phase
HIV Infections
 Drug: stavudine, efavirenz, lamivudine
Phase III

MedlinePlus related topics:  AIDS

Study Type: Interventional
Study Design: Treatment


Genders Eligible for Study:  Both

Inclusion Criteria:

  • Completed d4T studies AI455-096 or AI455-099
  • Have demonstrated compliance with the study medication and treatment visits
  • Provide written informed consent
  • Agree to use a barrier method of birth control (such as condoms) during the study
  • Have a negative pregnancy test within 72 hours prior to start of study medication

Exclusion Criteria:

  • Are pregnant or breast-feeding
  • Need to take certain medications that have systemic myelosuppressive, neurotoxic, pancreatotoxic, hepatotoxic or cytotoxic potential
  • Have active alcohol or substance abuse which may prevent compliance or increase risk of developing pancreatitis
  • Have certain other conditions or prior treatments that might interfere with study continuation
  • Need to take certain medications that should not be taken with EFV

Location Information

      Local Institution, Berkeley,  California,  United States

      Local Institution, Los Angeles,  California,  United States

      Local Institution, West Hollywood,  California,  United States

District of Columbia
      Local Institution, Washington,  District of Columbia,  United States

      Local Institution, Ft. Lauderdale,  Florida,  United States

      Local Institution, Orlando,  Florida,  United States

      Local Institution, Tampa,  Florida,  United States

      Local Institution, Indianapolis,  Indiana,  United States

      Local Institution, Wichita,  Kansas,  United States

      Local Institution, Louisville,  Kentucky,  United States

      Local Institution, Brookline,  Massachusetts,  United States

      Local Institution, Las Vegas,  Nevada,  United States

      Local Institution, Reno,  Nevada,  United States

New York
      Local Institution, New York,  New York,  United States

North Carolina
      Local Institution, Winston Salem,  North Carolina,  United States

      Local Institution, Oklahoma City,  Oklahoma,  United States

      Local Institution, Dallas,  Texas,  United States

      Local Institution, Houston,  Texas,  United States

      Local Institution, Hampton,  Virginia,  United States

      Local Institution, Buenos Aires,  Argentina

      Local Institution, Cordoba,  Argentina

Argentina, Buenos Aires
      Local Institution, San Isidro,  Buenos Aires,  Argentina

Argentina, Santa Fe
      Local Institution, Rosario,  Santa Fe,  Argentina

      Local Institution, Gent,  Belgium

      Local Institution, LIEGE,  Belgium

Brazil, Bahia
      Local Institution, Salvador,  Bahia,  Brazil

Brazil, Minas Gerais
      Local Institution, Belo Horizonte MG,  Minas Gerais,  Brazil

Brazil, Sao Paulo
      Local Institution, Botucatu,  Sao Paulo,  Brazil

      Local Institution, Santos,  Sao Paulo,  Brazil

Canada, British Columbia
      Local Institution, Vancouver,  British Columbia,  Canada

Canada, Ontario
      Local Institution, Toronto,  Ontario,  Canada

Canada, Quebec
      Local Institution, Montreal,  Quebec,  Canada

      Local Institution, Bordeaux Cedex,  France

      Local Institution, Lyon Cedex 03,  France

      Local Institution, Nantes Cedex 01,  France

      Local Institution, Paris Cedex 13,  France

      Local Institution, Rennes Cedex 9,  France

      Local Institution, Rehovot,  Israel

      Local Institution, Tel Hashorner,  Israel

      Local Institution, Bari,  Italy

      Local Institution, Bergamo,  Italy

      Local Institution, Firenze,  Italy

      Local Institution, Milano,  Italy

      Local Institution, Napoli,  Italy

      Local Institution, Pisa,  Italy

      Local Institution, Torino,  Italy

Mexico, Distrito Federal
      Local Institution, Mexico,  Distrito Federal,  Mexico

      Local Institution, Coimbra,  Portugal

      Local Institution, Lisboa,  Portugal

Puerto Rico
      Local Institution, Cotto Laurel,  Puerto Rico

      Local Institution, San Juan,  Puerto Rico

Russian Federation
      Local Institution, Moscow,  Russian Federation

      Local Institution, St Petersburg,  Russian Federation

      Local Institution, Singapore,  Singapore

South Africa, Gauteng
      Local Institution, Bedford Gardens,  Gauteng,  South Africa

      Local Institution, Hatfield,  Gauteng,  South Africa

      Local Institution, Johannesburg,  Gauteng,  South Africa

      Local Institution, Westdene,  Gauteng,  South Africa

South Africa, Western Cape
      Local Institution, Tygerberg,  Western Cape,  South Africa

      Local Institution, Barcelona,  Spain

      Local Institution, Madrid,  Spain

      Local Institution, Bangkok,  Thailand

      Local Institution, Nontaburi,  Thailand

More Information

Study ID Numbers:  AI455-110
Record last reviewed:  June 2005
Last Updated:  June 30, 2005
Record first received:  June 28, 2005 Identifier:  NCT00116298
Health Authority: United States: Food and Drug Administration processed this record on 2005-07-05


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