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

Purpose

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	Intervention	Phase
HIV Infections	Drug: Efavirenz Drug: Lamivudine Drug: Stavudine	Phase 3


Study Type:	Interventional
Study Design:	Endpoint Classification: Safety Study Masking: Double-Blind 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

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS HIV/AIDS Medicines

Drug Information available for: Stavudine Lamivudine Efavirenz

U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:


Estimated Enrollment:	730
Study Start Date:	June 2000
Study Completion Date:	April 2002
Primary Completion Date:	April 2002 (Final data collection date for primary outcome measure)

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).

Eligibility


Ages Eligible for Study:	12 Years and older
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00005918

Show 77 Study Locations

Sponsors and Collaborators

Bristol-Myers Squibb

More Information

Additional 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

No publications provided


ClinicalTrials.gov Identifier:	NCT00005918 History of Changes
Other Study ID Numbers:	244F, AI455-099
Study First Received:	June 15, 2000
Last Updated:	April 28, 2011
Health Authority:	United States: Food and Drug Administration

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:


Stavudine Anti-HIV Agents Anti-Infective Agents Anti-Retroviral Agents Antimetabolites Antiviral Agents	Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Nucleic Acid Synthesis Inhibitors Pharmacologic Actions Reverse Transcriptase Inhibitors Therapeutic Uses

ClinicalTrials.gov processed this record on February 27, 2015