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

Completed · Phase 3

Conditions studied: HIV Infections

In brief

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).

Key facts

Study ID

NCT00005918

Run by

Bristol-Myers Squibb

People needed

730

Starts

2000-06-01

Expected to finish

2002-04-01

Last updated by the study team

2011-05-04

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Whitman Walker Clinic — Washington D.C., District of Columbia, United States
• IDC Research Initiative — Altamonte Springs, Florida, United States
• Med Alternatives — Fort Lauderdale, Florida, United States
• Hillsborough County Health Dept — Tampa, Florida, United States
• The CORE Ctr — Chicago, Illinois, United States
• Univ of Kansas School of Medicine — Wichita, Kansas, United States
• Univ of Louisville — Louisville, Kentucky, United States
• CRI of New England — Brookline, Massachusetts, United States
• CRI - Springfield — Springfield, Massachusetts, United States
• No Nevada HOPES — Reno, Nevada, United States
• Saint Luke's - Roosevelt Hosp Ctr — New York, New York, United States
• Univ Hospital — Oklahoma City, Oklahoma, United States
• Aesculapisu Medical Health Group — Dallas, Texas, United States
• Univ of Texas Southwestern Med Ctr — Dallas, Texas, United States
• Univ of Texas Med Branch — Galveston, Texas, United States
• Plaza Med Ctr — Houston, Texas, United States
• Hampton Roads Med Specialists — Hampton, Virginia, United States
• Arnaldo Casiro MD — Buenos Aires, Argentina
• Claudia Rodriguez MD — Buenos Aires, Argentina
• Elida Pallone MD — Buenos Aires, Argentina
• Fundacion Huesped — Buenos Aires, Argentina
• Luis Maria Zieher MD — Buenos Aires, Argentina
• Fernando Silva Nieto MD — Prov Bs As, Argentina
• CAICI — Rosario Santa Fe, Argentina
• AIDS Healthcare Foundation — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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