HIV InfectionsNCT00002307
A Comparison of Zidovudine (AZT) and Stavudine in HIV-Infected Patients
A study testing Stavudine and Zidovudine in people with HIV Infections, run by Bristol-Myers Squibb at 45 sites in 2 countries.
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… Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- Stavudine and Zidovudine
- How many people
- Not given
- Where
- 45 sitesin 2 countries
- Study dates
- Start not givento Dec 1994
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
45 sites in 2 countries.
45 sites in 2 countries
United States44 sites
Univ of New Mexico School of Medicine
Albuquerque, New Mexico, 87131
Dr Steven Marlowe
Atlanta, Georgia, 30327
Chase Braxton Health Service
Baltimore, Maryland, 21201
East Bay AIDS Ctr
Berkeley, California, 94705
New England Deaconess Hosp
Boston, Massachusetts, 02215
Med Univ of South Carolina
Charleston, South Carolina, 29425
Nalle Clinic
Charlotte, North Carolina, 28207
Northwestern Univ Med School
Chicago, Illinois, 60611
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, 60612
Community Research Initiative of South Florida
Coral Gables, Florida, 33146
Univ of Texas Southwestern Med Ctr of Dallas
Dallas, Texas, 75235
Univ of Colorado Health Sciences Ctr
Denver, Colorado, 80262
Duke Univ Med Ctr
Durham, North Carolina, 27710
TheraFirst Med Ctrs Inc
Fort Lauderdale, Florida, 33308
Dr Edward Stool
Houston, Texas, 77004
Houston Clinical Research Network
Houston, Texas, 77006
Infectious Diseases Research Clinic / Indiana Univ Hosp
Indianapolis, Indiana, 46202
Univ of Kansas School of Medicine / Univ Hosp
Kansas City, Kansas, 661607354
Children's Hosp of Los Angeles
Los Angeles, California, 90027
Combat Group
Los Angeles, California, 90028
Los Angeles County - USC Med Ctr
Los Angeles, California, 90033
Cedars Sinai Med Ctr
Los Angeles, California, 90048
Univ of Miami
Miami, Florida, 331016960
Milwaukee County Med Complex
Milwaukee, Wisconsin, 53226
Beth Israel Med Ctr
New York, New York, 10003
Saint Luke's - Roosevelt Hosp Ctr
New York, New York, 10019
Cornell Univ Med College
New York, New York, 10021
Mount Sinai Med Ctr
New York, New York, 10029
Univ of Nebraska Med Ctr / HIV Clinic
Omaha, Nebraska, 681985130
Univ of Pennsylvania / HIV Clinic
Philadelphia, Pennsylvania, 19104
Buckley Braffman Stern Med Associates
Philadelphia, Pennsylvania, 19107
Montefiore Hosp
Pittsburgh, Pennsylvania, 15213
UCD Med Ctr / AIDS and Related Disorders Clinic
Sacramento, California, 95817
Univ of Utah School of Medicine
Salt Lake City, Utah, 84132
Univ TX San Antonio Health Science Ctr
San Antonio, Texas, 782847881
Children's Hosp of San Francisco
San Francisco, California, 94118
SUNY / Health Sciences Ctr at Stony Brook
Stony Brook, New York, 117948153
Infectious Disease Research Institute Inc
Tampa, Florida, 33614
Bronx Veterans Affairs Med Ctr
The Bronx, New York, 10468
Harbor UCLA Med Ctr
Torrance, California, 90502
Univ of Arizona / Health Science Ctr
Tucson, Arizona, 85724
Whitman - Walker Clinic
Washington D.C., District of Columbia, 20009
George Washington Univ Med Ctr
Washington D.C., District of Columbia, 20037
Univ of Kansas School of Medicine
Wichita, Kansas, 672143124
Puerto Rico1 site
UPR School of Medicine / San Juan Veterans Adm Med Ctr
San Juan, 009275800
About this study
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
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.
- Conditions
- HIV Infections
- Being tested
- Stavudine, Zidovudine
- Keywords
- Zidovudine, Stavudine
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
StavudineDrug
ZidovudineDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2001 (estimated)
- Study completionDec 1994
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002307
- Sponsor's protocol ID
- 116A
- Other IDs
- AI455-019
- Status last verified
- Aug 2011
- First submitted
- 2 Nov 1999
- Last updated
- 5 Aug 2011
- Results posted
- No
Publications
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.
PubMed 9054279
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00002307
- Acronym / sponsor ID
- 116A
- Conditions
- HIV Infections
- Keywords
- Zidovudine, Stavudine
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study completion
- Dec 1994 (actual)
- First posted
- 31 Aug 2001 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- AZT.
- 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.
Key exclusion criteria (22 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stavudine | Drug | – |
| Zidovudine | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2011.
- Background: PubMed 9054279Spruance 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
45 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stavudine and Zidovudine in people with HIV Infections, run by Bristol-Myers Squibb at 45 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 45 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00002307, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2011.