Effectiveness and Safety of Two Forms of Stavudine in HIV-Infected Patients

This study has been completed.

Sponsor:

Information provided by:

Bristol-Myers Squibb

ClinicalTrials.gov Identifier:

NCT00005918

First received: June 15, 2000

Last updated: April 28, 2011

Last verified: April 2011

History of Changes

Tracking Information
First Received Date ^ICMJE	June 15, 2000
Last Updated Date	April 28, 2011
Start Date ^ICMJE	June 2000
Primary Completion Date	April 2002 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE	Not Provided
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT00005918 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Effectiveness and Safety of Two Forms of Stavudine in HIV-Infected Patients
Official Title ^ICMJE	The Safety and Antiviral Efficacy of Stavudine Extended Release Formulation as Compared to Stavudine Immediate Release Formulation, Each as Part of Potent Antiretroviral Combination Therapy
Brief Summary	The purpose of this study is to compare the safety and effectiveness of 2 forms of stavudine (d4T). One form is taken once a day (extended release) and the other form is taken twice a day (immediate release).
Detailed Description	Patients are randomized to receive blinded stavudine extended release (d4T ER) or immediate release (d4T IR) formulation. Randomization is balanced by screening HIV viral load of less than 30,000 copies/ml or at least 30,000 copies/ml and by site. Patients also receive open-label efavirenz (EFV) and lamivudine (3TC). Efficacy is evaluated over 48 weeks of the dosing period and safety is evaluated over the entire dosing period (56 weeks).
Study Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Endpoint Classification: Safety Study Masking: Double-Blind Primary Purpose: Treatment
Condition ^ICMJE	HIV Infections
Intervention ^ICMJE	Drug: Efavirenz Drug: Lamivudine Drug: Stavudine
Study Arm (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	730
Completion Date	April 2002
Primary Completion Date	April 2002 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria Patients may be eligible for this study if they: Are at least 18 years old. Patients living in USA, Puerto Rico, Australia, Brazil, Singapore, and Thailand can be at least 12 years old (need consent of parent or guardian if under 18). Have a viral load of at least 2,000 copies/ml within 21 days of study entry. Have a CD4 count of at least 100 cells/mm3 within 21 days of study entry. Agree to use a barrier method of birth control (such as condoms) during the study. Are available for follow-up for at least 56 weeks. Exclusion Criteria Patients will not be eligible for this study if they: Are pregnant or breast-feeding. Have taken nonnucleoside reverse transcriptase inhibitors (NNRTIs) or protease inhibitors (PIs) for more than 30 days and within 14 days of study entry. Have a new opportunistic (HIV-related) infection or condition requiring treatment. Have acute (early) HIV infection. Have diarrhea (at least 6 loose stools/day for at least 7 days in a row) within 30 days prior to study entry. Abuse alcohol or drugs. Have active hepatitis within 30 days prior to study entry. Have a history of peripheral neuropathy (a condition affecting the nervous system). Cannot take medications by mouth. Are allergic to certain antiviral drugs. Need to take certain medications that should not be taken with EFV. Have certain other conditions or prior treatments that might affect the study.
Gender	Both
Ages	12 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States, Argentina, Australia, Belgium, Brazil, Canada, France, Israel, Italy, Mexico, Portugal, Puerto Rico, Russian Federation, Singapore, South Africa, Spain, Thailand

Administrative Information
NCT Number ^ICMJE	NCT00005918
Other Study ID Numbers ^ICMJE	244F, AI455-099
Has Data Monitoring Committee	Not Provided
Responsible Party	Not Provided
Study Sponsor ^ICMJE	Bristol-Myers Squibb
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Bristol-Myers Squibb
Verification Date	April 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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