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

Sponsored by:	Bristol-Myers Squibb
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00116298

Purpose

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

MedlinePlus related topics: AIDS

Drug Information available for: Lamivudine Stavudine Efavirenz

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Study 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 BMS Studies AI455-096 and AI455-099

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:

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 Outcome Measures:

Efficacy: Changes in CD4 cell counts

Estimated Enrollment:	900
Study Start Date:	January 2001

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00116298

Show 63 Study Locations

Sponsors and Collaborators

Bristol-Myers Squibb

More Information

BMS Clinical Trials Disclosure This link exits the ClinicalTrials.gov site

For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm This link exits the ClinicalTrials.gov site

Study ID Numbers:	AI455-110
Study First Received:	June 28, 2005
Last Updated:	June 27, 2008
ClinicalTrials.gov Identifier:	NCT00116298
Health Authority:	United States: Food and Drug Administration

Keywords provided by Bristol-Myers Squibb:

Antivirals
HIV

Study placed in the following topic categories:

Virus Diseases
Efavirenz
Sexually Transmitted Diseases, Viral
Stavudine
HIV Infections

Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Lamivudine
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
RNA Virus Infections
Anti-HIV Agents
Slow Virus Diseases
Immune System Diseases
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors

Infection
Antiviral Agents
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Anti-Retroviral Agents
Therapeutic Uses
Lentivirus Infections
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on January 14, 2009