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 AIDS	Drug: stavudine, efavirenz, lamivudine	Phase III

Genders Eligible for Study:  Both

Criteria

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

California
      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
Florida
      Local Institution, Ft. Lauderdale,  Florida,  United States
      Local Institution, Orlando,  Florida,  United States
      Local Institution, Tampa,  Florida,  United States
Indiana
      Local Institution, Indianapolis,  Indiana,  United States
Kansas
      Local Institution, Wichita,  Kansas,  United States
Kentucky
      Local Institution, Louisville,  Kentucky,  United States
Massachusetts
      Local Institution, Brookline,  Massachusetts,  United States
Nevada
      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
Oklahoma
      Local Institution, Oklahoma City,  Oklahoma,  United States
Texas
      Local Institution, Dallas,  Texas,  United States
      Local Institution, Houston,  Texas,  United States
Virginia
      Local Institution, Hampton,  Virginia,  United States
Argentina
      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
Belgium
      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
France
      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
Israel
      Local Institution, Rehovot,  Israel
      Local Institution, Tel Hashorner,  Israel
Italy
      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
Portugal
      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
Singapore
      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
Spain
      Local Institution, Barcelona,  Spain
      Local Institution, Madrid,  Spain
Thailand
      Local Institution, Bangkok,  Thailand
      Local Institution, Nontaburi,  Thailand

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