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

NCT00116298 | Completed Phase 3

• 1 other identifier: AI455-110
• Study Type: interventional
• Target: 900
• Locations: 16 countries
• Sites: 63

Brief Summary

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.

Conditions

HIV Infections; AIDS

Keywords

Antivirals; HIV

Outcome Measures

Primary Outcomes (1)

• Safety: Frequency and severity of AEs, and treatment discontinuations for AEs; population trends for triglycerides and cholesterol. Primary efficacy outcome: proportion of subjects with HIVRNA <400, <50, and change in viral load over the study period

Secondary Outcomes (1)

• Efficacy: Changes in CD4 cell counts

Interventions

stavudine, efavirenz, lamivudine DRUG

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (63)

Local Institution

Berkeley, California, United States

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Los Angeles, California, United States

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West Hollywood, California, United States

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Washington D.C., District of Columbia, United States

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Fort Lauderdale, Florida, United States

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Orlando, Florida, United States

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Tampa, Florida, United States

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Indianapolis, Indiana, United States

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Wichita, Kansas, United States

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Louisville, Kentucky, United States

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Brookline, Massachusetts, United States

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Las Vegas, Nevada, United States

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Reno, Nevada, United States

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New York, New York, United States

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Winston-Salem, North Carolina, United States

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Oklahoma City, Oklahoma, United States

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Dallas, Texas, United States

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Houston, Texas, United States

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Hampton, Virginia, United States

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San Isidro, Buenos Aires, Argentina

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Rosario, Santa Fe Province, Argentina

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Buenos Aires, Argentina

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Córdoba, Argentina

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Ghent, Belgium

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Liège, Belgium

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Salvador, Estado de Bahia, Brazil

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Belo Horizonte - MG, Minas Gerais, Brazil

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Botucatu, São Paulo, Brazil

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Santos, São Paulo, Brazil

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Vancouver, British Columbia, Canada

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Toronto, Ontario, Canada

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Montreal, Quebec, Canada

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Bordeaux, France

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Lyon, France

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Nantes, France

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Paris, France

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Rennes, France

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Rehovot, Israel

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Tel Hashorner, Israel

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Bari, Italy

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Bergamo, Italy

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Florence, Italy

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Milan, Italy

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Napoli, Italy

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Pisa, Italy

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Torino, Italy

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Mexico City, Mexico City, Mexico

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Coimbra, Portugal

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Lisbon, Portugal

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Cotto Laurel, Puerto Rico

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San Juan, Puerto Rico

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Moscow, Russia

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Saint Petersburg, Russia

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Singapore, Singapore

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Bedford Gardens, Gauteng, South Africa

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Hatfield, Gauteng, South Africa

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Johannesburg, Gauteng, South Africa

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Westdene, Gauteng, South Africa

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Tygerberg, Western Cape, South Africa

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Barcelona, Spain

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Madrid, Spain

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Bangkok, Thailand

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Nontaburi, Thailand

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MeSH Terms

Conditions

HIV Infections; Acquired Immunodeficiency Syndrome

Interventions

Stavudine; efavirenz; Lamivudine

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases

Intervention Hierarchy (Ancestors)

Thymidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Dideoxynucleosides; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Zalcitabine; Deoxycytidine; Cytidine

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 28, 2005
• First Posted: June 29, 2005
• Study Start: January 1, 2001
• Primary Completion: January 1, 2005
• Study Completion: January 1, 2005
• Last Updated: April 25, 2011

Record last verified: 2011-04

Locations

CA (3); ZA (5); SG (1); RU (2); IL (2); AR (4); BE (2); PT (2); ME (1); ES (2); US (19); FR (5); BR (4); PR (2); TH (2); IT (7)