A Comparison of Zidovudine (AZT) and Stavudine in HIV-Infected Patients

HIV Infections Clinical Trial

Official title:

A Double-Blind Comparison of Zidovudine (AZT) Versus Stavudine (d4T; BMY 27857) for the Treatment of Patients With HIV Infection Who Have Absolute CD4 Lymphocyte Counts Between 50 and 500 Cells/mm3

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002307
• Other study ID #: 116A
• Secondary ID: AI455-019
• Status: Completed
• Phase: N/A
• First received: November 2, 1999
• Last updated: August 4, 2011
• Est. completion date: December 1994

Study information

• Verified date: August 2011
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

To compare stavudine (d4T) and zidovudine (AZT) in slowing the progression of HIV disease. To compare the antiviral activity of d4T versus AZT as measured by plasma levels of p24 antigen and HIV viremia, and their relative efficacy by improvement and/or absence of adverse changes over time in laboratory parameters associated with HIV infection. To compare the safety of oral doses of d4T to AZT in patients with HIV infection.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: December 1994
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 13 Years and older

Eligibility

Inclusion Criteria

Concurrent Medication:

Allowed:

• AZT.

Patients must have:

• Documented HIV infection as determined by a positive ELISA and/or Western blot.

• Absolute CD4 count of 100 - 500 cells/mm3 within 90 days prior to registration OR a CD4 count of 50 - 99 cells/mm3 within 30 days prior to registration.

• Prior zidovudine therapy for at least 6 months and currently tolerating at least 500 mg daily.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms and conditions are excluded:

• Newly diagnosed AIDS-defining opportunistic infection requiring acute therapy at time of enrollment.

• Need for chronic systemic therapy at time of enrollment.

• Intractable diarrhea.

• Signs or symptoms of bilateral peripheral neuropathy at time of screening.

• Demonstrated intolerance to zidovudine therapy.

• Any other clinical conditions that would render the patient unsuitable for study or unable to comply with the dosing requirements.

Concurrent Medication:

Excluded:

• Chronic systemic therapy with agents likely to suppress bone marrow, cause neurotoxicity, or create hepatic dysfunction.

Patients with the following prior conditions are excluded:

• Prior history of bilateral peripheral neuropathy.

• Demonstrated intolerance to zidovudine therapy.

Prior Medication:

Excluded:

• Prior d4T, ddI, or ddC.

• Other investigational antiretroviral drugs (e.g., AZddU, Al 721, interferon, or immunomodulating drugs within 1 month prior to study entry or ribavirin within 3 months prior to study entry).

• Prior myelosuppressive, neurotoxic, or cytotoxic anticancer therapy within 3 months prior to study entry.

• Any prior therapy that would render the patient unsuitable for study or unable to comply with dosing requirements.

Required:

• At least 6 months of prior AZT and currently tolerating at least 500 mg daily, with the last dose received no more than 7 days prior to study entry.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections

Intervention

Drug:
• Stavudine

• Zidovudine

Locations

Country	Name	City	State
Puerto Rico	UPR School of Medicine / San Juan Veterans Adm Med Ctr	San Juan
United States	Univ of New Mexico School of Medicine	Albuquerque	New Mexico
United States	Dr Steven Marlowe	Atlanta	Georgia
United States	Chase Braxton Health Service	Baltimore	Maryland
United States	East Bay AIDS Ctr	Berkeley	California
United States	New England Deaconess Hosp	Boston	Massachusetts
United States	Bronx Veterans Affairs Med Ctr	Bronx	New York
United States	Med Univ of South Carolina	Charleston	South Carolina
United States	Nalle Clinic	Charlotte	North Carolina
United States	Northwestern Univ Med School	Chicago	Illinois
United States	Rush Presbyterian - Saint Luke's Med Ctr	Chicago	Illinois
United States	Community Research Initiative of South Florida	Coral Gables	Florida
United States	Univ of Texas Southwestern Med Ctr of Dallas	Dallas	Texas
United States	Univ of Colorado Health Sciences Ctr	Denver	Colorado
United States	Duke Univ Med Ctr	Durham	North Carolina
United States	TheraFirst Med Ctrs Inc	Fort Lauderdale	Florida
United States	Dr Edward Stool	Houston	Texas
United States	Houston Clinical Research Network	Houston	Texas
United States	Infectious Diseases Research Clinic / Indiana Univ Hosp	Indianapolis	Indiana
United States	Univ of Kansas School of Medicine / Univ Hosp	Kansas City	Kansas
United States	Cedars Sinai Med Ctr	Los Angeles	California
United States	Children's Hosp of Los Angeles	Los Angeles	California
United States	Combat Group	Los Angeles	California
United States	Los Angeles County - USC Med Ctr	Los Angeles	California
United States	Univ of Miami	Miami	Florida
United States	Milwaukee County Med Complex	Milwaukee	Wisconsin
United States	Beth Israel Med Ctr	New York	New York
United States	Cornell Univ Med College	New York	New York
United States	Mount Sinai Med Ctr	New York	New York
United States	Saint Luke's - Roosevelt Hosp Ctr	New York	New York
United States	Univ of Nebraska Med Ctr / HIV Clinic	Omaha	Nebraska
United States	Buckley Braffman Stern Med Associates	Philadelphia	Pennsylvania
United States	Univ of Pennsylvania / HIV Clinic	Philadelphia	Pennsylvania
United States	Montefiore Hosp	Pittsburgh	Pennsylvania
United States	UCD Med Ctr / AIDS and Related Disorders Clinic	Sacramento	California
United States	Univ of Utah School of Medicine	Salt Lake City	Utah
United States	Univ TX San Antonio Health Science Ctr	San Antonio	Texas
United States	Children's Hosp of San Francisco	San Francisco	California
United States	SUNY / Health Sciences Ctr at Stony Brook	Stony Brook	New York
United States	Infectious Disease Research Institute Inc	Tampa	Florida
United States	Harbor UCLA Med Ctr	Torrance	California
United States	Univ of Arizona / Health Science Ctr	Tucson	Arizona
United States	George Washington Univ Med Ctr	Washington	District of Columbia
United States	Whitman - Walker Clinic	Washington	District of Columbia
United States	Univ of Kansas School of Medicine	Wichita	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Puerto Rico, 

References & Publications (1)

Spruance SL, Pavia AT, Mellors JW, Murphy R, Gathe J Jr, Stool E, Jemsek JG, Dellamonica P, Cross A, Dunkle L. Clinical efficacy of monotherapy with stavudine compared with zidovudine in HIV-infected, zidovudine-experienced patients. A randomized, double-blind, controlled trial. Bristol-Myers Squibb Stavudine/019 Study Group. Ann Intern Med. 1997 Mar 1;126(5):355-63. — View Citation

External Links

•   BMS Clinical Trials Disclosure
•   For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm