Clinical trial NCT00002307: A Comparison of Zidovudine (AZT) and Stavudine in HIV-Infected Patients
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infections
Keywords: Zidovudine
Stavudine
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2001-08-31
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Univ of Arizona / Health Science Ctr
state: Arizona
city: Berkeley
country: United States
facility: East Bay AIDS Ctr
state: California
city: Los Angeles
country: United States
facility: Children's Hosp of Los Angeles
state: California
city: Los Angeles
country: United States
facility: Combat Group
state: California
city: Los Angeles
country: United States
facility: Los Angeles County - USC Med Ctr
state: California
city: Los Angeles
country: United States
facility: Cedars Sinai Med Ctr
state: California
city: Sacramento
country: United States
facility: UCD Med Ctr / AIDS and Related Disorders Clinic
state: California
city: San Francisco
country: United States
facility: Children's Hosp of San Francisco
state: California
city: Torrance
country: United States
facility: Harbor UCLA Med Ctr
state: California
city: Denver
country: United States
facility: Univ of Colorado Health Sciences Ctr
state: Colorado
city: Washington
country: United States
facility: Whitman - Walker Clinic
state: District of Columbia
city: Washington
country: United States
facility: George Washington Univ Med Ctr
state: District of Columbia
city: Coral Gables
country: United States
facility: Community Research Initiative of South Florida
state: Florida
city: Fort Lauderdale
country: United States
facility: TheraFirst Med Ctrs Inc
state: Florida
city: Miami
country: United States
facility: Univ of Miami
state: Florida
city: Tampa
country: United States
facility: Infectious Disease Research Institute Inc
state: Florida
city: Atlanta
country: United States
facility: Dr Steven Marlowe
state: Georgia
city: Chicago
country: United States
facility: Northwestern Univ Med School
state: Illinois
city: Chicago
country: United States
facility: Rush Presbyterian - Saint Luke's Med Ctr
state: Illinois
city: Indianapolis
country: United States
facility: Infectious Diseases Research Clinic / Indiana Univ Hosp
state: Indiana
city: Kansas City
country: United States
facility: Univ of Kansas School of Medicine / Univ Hosp
state: Kansas
city: Wichita
country: United States
facility: Univ of Kansas School of Medicine
state: Kansas
city: Baltimore
country: United States
facility: Chase Braxton Health Service
state: Maryland
city: Boston
country: United States
facility: New England Deaconess Hosp
state: Massachusetts
city: Omaha
country: United States
facility: Univ of Nebraska Med Ctr / HIV Clinic
state: Nebraska
city: Albuquerque
country: United States
facility: Univ of New Mexico School of Medicine
state: New Mexico
city: Bronx
country: United States
facility: Bronx Veterans Affairs Med Ctr
state: New York
city: New York
country: United States
facility: Beth Israel Med Ctr
state: New York
city: New York
country: United States
facility: Saint Luke's - Roosevelt Hosp Ctr
state: New York
city: New York
country: United States
facility: Cornell Univ Med College
state: New York
city: New York
country: United States
facility: Mount Sinai Med Ctr
state: New York
city: Stony Brook
country: United States
facility: SUNY / Health Sciences Ctr at Stony Brook
state: New York
city: Charlotte
country: United States
facility: Nalle Clinic
state: North Carolina
city: Durham
country: United States
facility: Duke Univ Med Ctr
state: North Carolina
city: Philadelphia
country: United States
facility: Univ of Pennsylvania / HIV Clinic
state: Pennsylvania
city: Philadelphia
country: United States
facility: Buckley Braffman Stern Med Associates
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Montefiore Hosp
state: Pennsylvania
city: Charleston
country: United States
facility: Med Univ of South Carolina
state: South Carolina
city: Dallas
country: United States
facility: Univ of Texas Southwestern Med Ctr of Dallas
state: Texas
city: Houston
country: United States
facility: Dr Edward Stool
state: Texas
city: Houston
country: United States
facility: Houston Clinical Research Network
state: Texas
city: San Antonio
country: United States
facility: Univ TX San Antonio Health Science Ctr
state: Texas
city: Salt Lake City
country: United States
facility: Univ of Utah School of Medicine
state: Utah
city: Milwaukee
country: United States
facility: Milwaukee County Med Complex
state: Wisconsin
city: San Juan
country: Puerto Rico
facility: UPR School of Medicine / San Juan Veterans Adm Med Ctr
Study officials:
name: . ., .
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.7326/0003-4819-126-5-199703010-00003.