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

NCT ID: NCT00116298

Last Updated: 2011-04-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

900 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-01-31

Study Completion Date

2005-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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HIV Infections AIDS

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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stavudine, efavirenz, lamivudine

Intervention Type DRUG

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Locations

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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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Countries

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United States Argentina Belgium Brazil Canada France Israel Italy Mexico Portugal Puerto Rico Russia Singapore South Africa Spain Thailand

Other Identifiers

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AI455-110

Identifier Type: -

Identifier Source: org_study_id

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