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

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ClinicalTrials.gov Identifier: NCT00005918

Recruitment Status : Completed

First Posted : August 31, 2001

Last Update Posted : May 4, 2011

Sponsor:

Information provided by:

Bristol-Myers Squibb

Study Description

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).

Condition or disease	Intervention/treatment	Phase
HIV Infections	Drug: Efavirenz Drug: Lamivudine Drug: Stavudine	Phase 3

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 Design


Study Type :	Interventional (Clinical Trial)
Enrollment :	730 participants
Masking:	Double
Primary Purpose:	Treatment
Official Title:	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
Study Start Date :	June 2000
Actual Primary Completion Date :	April 2002
Actual Study Completion Date :	April 2002

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Drug Information available for: Stavudine

U.S. FDA Resources

Arms and Interventions

Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	12 Years and older (Child, Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00005918

Show 76 Study Locations

Sponsors and Collaborators

Bristol-Myers Squibb

More Information

Additional Information:

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


ClinicalTrials.gov Identifier:	NCT00005918 History of Changes
Other Study ID Numbers:	244F AI455-099
First Posted:	August 31, 2001 Key Record Dates
Last Update Posted:	May 4, 2011
Last Verified:	April 2011

Keywords provided by Bristol-Myers Squibb:


Drug Therapy, Combination Stavudine Lamivudine RNA, Viral Dosage Forms	Reverse Transcriptase Inhibitors Anti-HIV Agents Viral Load efavirenz

Additional relevant MeSH terms:


HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Lamivudine Efavirenz Stavudine Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors	Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Anti-HIV Agents Cytochrome P-450 CYP2C9 Inhibitors Cytochrome P-450 Enzyme Inhibitors Cytochrome P-450 CYP2C19 Inhibitors Cytochrome P-450 CYP2B6 Inducers Cytochrome P-450 Enzyme Inducers Cytochrome P-450 CYP3A Inducers Antimetabolites

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