HIV InfectionsPhase 3NCT00116298
Rollover Study for Zerit (Stavudine) ER Studies (-096, -099)
A Phase 3 study testing stavudine, efavirenz, lamivudine in people with HIV Infections and AIDS, run by Bristol-Myers Squibb at 63 sites in 16 countries.
Trial summary
The purpose of this study is to compare long-term safety and tolerability of stavudine (d4T) extended release (ER) versus conventional (immediate release [IR]) formulations, each in combination with lamivudine (3TC) and efavirenz (EFV) in subjects who have completed Bristol-Myers Squibb (BMS) studies AI455-096 and… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- HIV Infections, AIDS
- What is being tested?
- stavudine, efavirenz, lamivudine
- How many people
- 900 participants
- Where
- 63 sitesin 16 countries
- Study dates
- Jan 2001to Jan 2005
- Phase
- Phase 3
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Completed d4T studies AI455-096 or AI455-099
- Have demonstrated compliance with the study medication and treatment visits
- Provide written informed consent
- Agree to use a barrier method of birth control (such as condoms) during the study
- Have a negative pregnancy test within 72 hours prior to start of study medication
Who cannot join
- Are pregnant or breast-feeding
- Need to take certain medications that have systemic myelosuppressive, neurotoxic, pancreatotoxic, hepatotoxic or cytotoxic potential
- Have active alcohol or substance abuse which may prevent compliance or increase risk of developing pancreatitis
- Have certain other conditions or prior treatments that might interfere with study continuation
- Need to take certain medications that should not be taken with EFV
Trial locations and contacts
63 sites in 16 countries.
63 sites in 16 countries
United States19 sites
Local Institution
Berkeley, California
Local Institution
Brookline, Massachusetts
Local Institution
Dallas, Texas
Local Institution
Fort Lauderdale, Florida
Local Institution
Hampton, Virginia
Local Institution
Houston, Texas
Local Institution
Indianapolis, Indiana
Local Institution
Las Vegas, Nevada
Local Institution
Los Angeles, California
Local Institution
Louisville, Kentucky
Local Institution
New York, New York
Local Institution
Oklahoma City, Oklahoma
Local Institution
Orlando, Florida
Local Institution
Reno, Nevada
Local Institution
Tampa, Florida
Local Institution
Washington D.C., District of Columbia
Local Institution
West Hollywood, California
Local Institution
Wichita, Kansas
Local Institution
Winston-Salem, North Carolina
Italy7 sites
Local Institution
Bari
Local Institution
Bergamo
Local Institution
Florence
Local Institution
Milan
Local Institution
Naples
Local Institution
Pisa
Local Institution
Torino
France5 sites
Local Institution
Bordeaux
Local Institution
Lyon
Local Institution
Nantes
Local Institution
Paris
Local Institution
Rennes
South Africa5 sites
Local Institution
Bedford Gardens, Gauteng
Local Institution
Hatfield, Gauteng
Local Institution
Johannesburg, Gauteng
Local Institution
Tygerberg, Western Cape
Local Institution
Westdene, Gauteng
Argentina4 sites
Local Institution
Buenos Aires
Local Institution
Córdoba
Local Institution
Rosario, Santa Fe Province
Local Institution
San Isidro, Buenos Aires
Brazil4 sites
Local Institution
Belo Horizonte - MG, Minas Gerais
Local Institution
Botucatu, São Paulo
Local Institution
Salvador, Estado de Bahia
Local Institution
Santos, São Paulo
Canada3 sites
Local Institution
Montreal, Quebec
Local Institution
Toronto, Ontario
Local Institution
Vancouver, British Columbia
Puerto Rico2 sites
Local Institution
Cotto Laurel
Local Institution
San Juan
About this study
Official title: A Study to Compare Long-Term Safety and Tolerability of Stavudine (d4T) Extended Release (ER) Versus Conventional (Immediate Release, IR) Formulations, Each In Combination With Lamivudine (3TC) and Efavirenz (EFV) in Subjects Who Have Completed BMS Studies AI455-096 and AI455-099
The purpose of this study is to compare long-term safety and tolerability of stavudine (d4T) extended release (ER) versus conventional (immediate release [IR]) formulations, each in combination with lamivudine (3TC) and efavirenz (EFV) in subjects who have completed Bristol-Myers Squibb (BMS) studies AI455-096 and AI455-099.
- Conditions
- HIV Infections, AIDS
- Being tested
- stavudine, efavirenz, lamivudine
- Keywords
- Antivirals, HIV
- Medical subject headings
- HIV Infections, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stavudine, efavirenz, lamivudineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety: Frequency and severity of AEs, and treatment discontinuations for AEs; population trends for triglycerides and cholesterol. Primary efficacy outcome: proportion of subjects with HIVRNA <400, <50, and change in viral load over the study period
Secondary outcomes (1)
Efficacy: Changes in CD4 cell counts
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2005 (estimated)
- Study startJan 2001
- Primary completionJan 2005
- Study completionJan 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 900 participants
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00116298
- Sponsor's protocol ID
- AI455-110
- Status last verified
- Apr 2011
- First submitted
- 28 Jun 2005
- Last updated
- 25 Apr 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Compare Long-Term Safety and Tolerability of Stavudine (d4T) Extended Release (ER) Versus Conventional (Immediate Release, IR) Formulations, Each In Combination With Lamivudine (3TC) and Efavirenz (EFV) in Subjects Who Have Completed BMS Studies AI455-096 and AI455-099
- ClinicalTrials.gov ID
- NCT00116298
- Acronym / sponsor ID
- AI455-110
- Conditions
- HIV Infections, AIDS
- Keywords
- Antivirals, HIV
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 900 participants
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- Jan 2001
- Primary completion
- Jan 2005 (actual)
- Study completion
- Jan 2005 (actual)
- First posted
- 29 Jun 2005 (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.
The purpose of this study is to compare long-term safety and tolerability of stavudine (d4T) extended release (ER) versus conventional (immediate release [IR]) formulations, each in combination with lamivudine (3TC) and efavirenz (EFV) in subjects who have completed Bristol-Myers Squibb (BMS) studies AI455-096 and AI455-099.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Completed d4T studies AI455-096 or AI455-099
- Have demonstrated compliance with the study medication and treatment visits
- Provide written informed consent
- Agree to use a barrier method of birth control (such as condoms) during the study
- Have a negative pregnancy test within 72 hours prior to start of study medication
Key exclusion criteria (5 listed)
- Are pregnant or breast-feeding
- Need to take certain medications that have systemic myelosuppressive, neurotoxic, pancreatotoxic, hepatotoxic or cytotoxic potential
- Have active alcohol or substance abuse which may prevent compliance or increase risk of developing pancreatitis
- Have certain other conditions or prior treatments that might interfere with study continuation
- Need to take certain medications that should not be taken with EFV
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, efavirenz, lamivudine | Drug | – |
Primary outcome
Safety: Frequency and severity of AEs, and treatment discontinuations for AEs; population trends for triglycerides and cholesterol. Primary efficacy outcome: proportion of subjects with HIVRNA <400, <50, and change in viral load over the study period
1 secondary outcome
Efficacy: Changes in CD4 cell counts
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 25 Apr 2011.
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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.
63 sites in 16 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing stavudine, efavirenz, lamivudine in people with HIV Infections and AIDS, run by Bristol-Myers Squibb at 63 sites in 16 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 5 inclusion and 5 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 25 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 63 sites in United States, Italy, France, South Africa, Argentina and 11 more countries. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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.
What does the primary outcome measure?
Safety: Frequency and severity of AEs, and treatment discontinuations for AEs; population trends for triglycerides and cholesterol. Primary efficacy outcome: proportion of subjects with HIVRNA <400, <50, and change in viral load over the study period. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Apr 2011; AzTrials last refreshed its copy on 1 Nov 2026.