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.
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.
UPR School of Medicine / San Juan Veterans Adm Med Ctr, San Juan 009275800, Puerto Rico
Univ of Arizona / Health Science Ctr, Tucson, Arizona 85724, United States
East Bay AIDS Ctr, Berkeley, California 94705, United States
Combat Group, Los Angeles, California 90028, United States
Cedars Sinai Med Ctr, Los Angeles, California 90048, United States
Children's Hosp of Los Angeles, Los Angeles, California 90027, United States
Los Angeles County - USC Med Ctr, Los Angeles, California 90033, United States
UCD Med Ctr / AIDS and Related Disorders Clinic, Sacramento, California 95817, United States
Children's Hosp of San Francisco, San Francisco, California 94118, United States
Harbor UCLA Med Ctr, Torrance, California 90502, United States
Univ of Colorado Health Sciences Ctr, Denver, Colorado 80262, United States
Whitman - Walker Clinic, Washington, District of Columbia 20009, United States
George Washington Univ Med Ctr, Washington, District of Columbia 20037, United States
Univ of Miami, Miami, Florida 331016960, United States
Community Research Initiative of South Florida, Coral Gables, Florida 33146, United States
TheraFirst Med Ctrs Inc, Fort Lauderdale, Florida 33308, United States
Infectious Disease Research Institute Inc, Tampa, Florida 33614, United States
Dr Steven Marlowe, Atlanta, Georgia 30327, United States
Northwestern Univ Med School, Chicago, Illinois 60611, United States
Rush Presbyterian - Saint Luke's Med Ctr, Chicago, Illinois 60612, United States
Infectious Diseases Research Clinic / Indiana Univ Hosp, Indianapolis, Indiana 46202, United States
Univ of Kansas School of Medicine / Univ Hosp, Kansas City, Kansas 661607354, United States
Univ of Kansas School of Medicine, Wichita, Kansas 672143124, United States
Chase Braxton Health Service, Baltimore, Maryland 21201, United States
New England Deaconess Hosp, Boston, Massachusetts 02215, United States
Univ of Nebraska Med Ctr / HIV Clinic, Omaha, Nebraska 681985130, United States
Univ of New Mexico School of Medicine, Albuquerque, New Mexico 87131, United States
Bronx Veterans Affairs Med Ctr, Bronx, New York 10468, United States
Saint Luke's - Roosevelt Hosp Ctr, New York, New York 10019, United States
Beth Israel Med Ctr, New York, New York 10003, United States
Cornell Univ Med College, New York, New York 10021, United States
SUNY / Health Sciences Ctr at Stony Brook, Stony Brook, New York 117948153, United States
Mount Sinai Med Ctr, New York, New York 10029, United States
Nalle Clinic, Charlotte, North Carolina 28207, United States
Duke Univ Med Ctr, Durham, North Carolina 27710, United States
Univ of Pennsylvania / HIV Clinic, Philadelphia, Pennsylvania 19104, United States
Montefiore Hosp, Pittsburgh, Pennsylvania 15213, United States
Buckley Braffman Stern Med Associates, Philadelphia, Pennsylvania 19107, United States
Med Univ of South Carolina, Charleston, South Carolina 29425, United States
Houston Clinical Research Network, Houston, Texas 77006, United States
Dr Edward Stool, Houston, Texas 77004, United States
Univ TX San Antonio Health Science Ctr, San Antonio, Texas 782847881, United States
Univ of Texas Southwestern Med Ctr of Dallas, Dallas, Texas 75235, United States
Univ of Utah School of Medicine, Salt Lake City, Utah 84132, United States
Milwaukee County Med Complex, Milwaukee, Wisconsin 53226, United States
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.
