HIV InfectionsPhase 3NCT00002371
The Safety and Effectiveness of Lamivudine Plus Stavudine or Zidovudine in HIV-Infected Patients Who Have Taken Zidovudine
A Phase 3 study testing Indinavir sulfate, Lamivudine and Stavudine in people with HIV Infections, run by Bristol-Myers Squibb at 8 sites in 3 countries.
Trial summary
To compare the magnitude and durability of the reduction in plasma HIV RNA in the two treatment groups over the first 12 weeks of treatment. To determine the safety of each of the two treatment groups. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- Indinavir sulfate, Lamivudine and Stavudine
- How many people
- 80 participants
- Where
- 8 sitesin 3 countries
- Study dates
- Jun 1996to Dec 1997
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have:
- At least six months of prior cumulative ZDV therapy.
- Qualifying plasma HIV RNA count of >= 4 log10 copies/ml obtained within 2 weeks of randomization.
Who cannot join
- Co-existing Condition:
- Patients with any of the following symptoms or conditions are excluded:
- Presence of newly diagnosed AIDS defining opportunistic infection requiring acute therapy at time of enrollment.
- Intractable diarrhea (>= 6 loose stools/day for >= 7 consecutive days).
- Signs and symptoms of bilateral peripheral neuropathy >= grade 2 at the time of screening.
- Inability to tolerate oral medication.
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- Any other clinical conditions that in the opinion of the investigator, would make the patient unsuitable for study or unable to comply with the dosing requirements.
- Concurrent Medication:
- Excluded:
- Therapy with agents with systemic myelosuppressive, neurotoxic pancreatotoxic, hepatotoxic or cytotoxic potential.
- Therapy with rifampin, rifabutin, terfenadine, astemizole, cisapride, triazolam, midazolam and ketoconazole at any time while on indinavir therapy.
- Patients with any of the following prior conditions or symptoms are excluded:
- History of acute or chronic pancreatitis.
- Prior history of bilateral peripheral neuropathy.
- Intractable diarrhea (>= 6 loose stools/day for >= 7 consecutive days) within 30 days prior to study entry.
- Prior Medication:
- Excluded:
- Any prior antiretroviral therapy except for ddI, ddC, 3TC or ZDV (for ZDV, as specified in inclusion criteria).
- Previous therapy with agents with significant systemic myelosuppressive, neurotoxic pancreatotoxic, hepatotoxic or cytotoxic potential within 3 months of study start.
- Therapy with rifampin, rifabutin, terfenadine, astemizole, cisapride, triazolam, midazolam and ketoconazole within 2 weeks prior to starting indinavir.
- Any other prior therapy that, in the opinion of the investigator, would make the patient unsuitable for study or unable to comply with the dosing regimen.
- Risk Behavior:
- Excluded:
- Active alcohol abuse, sufficient in the investigator's opinion, to prevent compliance with study therapy or to increase the risk of developing pancreatitis.
- Required:
- At least 6 months of prior cumulative ZDV therapy.
Trial locations and contacts
8 sites in 3 countries.
8 sites in 3 countries
United States5 sites
Houston Clinical Research Network / Div of Montrose Clinic
Houston, Texas, 77006
Univ of Utah / School of Medicine / Div of Infect Dis
Salt Lake City, Utah, 84132
SUNY at Stony Brook / Division of Infectious Diseases
Stony Brook, New York, 11794
Univ of South Florida
Tampa, Florida, 33612
Harbor UCLA Med Ctr
Torrance, California, 90502
Canada2 sites
Montreal Gen Hosp / Div of Clin Immuno and Allergy
Montreal, Quebec
Sunnybrook Health Science Ctr
North York, Ontario
About this study
Official title: A Randomized Double-Blind Study of Safety, Virologic and Immunological Effects of Stavudine Plus Lamivudine (3TC) Versus Zidovudine Plus Lamivudine in HIV-Infected Subjects Following At Least Six Months of Zidovudine Therapy
To compare the magnitude and durability of the reduction in plasma HIV RNA in the two treatment groups over the first 12 weeks of treatment. To determine the safety of each of the two treatment groups.
Read the detailed description
Patients will be randomized to either Stavudine (d4T) + Lamivudine (3TC) + Zidovudine placebo or Zidovudine (ZDV) + Lamivudine + Stavudine placebo. Patients whose plasma HIV RNA levels remain >= 500 copies/ml after 8 weeks of blinded double combination therapy will have indinavir added to their treatment regimen at the week 12 visit.
- Conditions
- HIV Infections
- Being tested
- Indinavir sulfate, Lamivudine, Stavudine, Zidovudine
- Keywords
- HIV-1, Drug Therapy, Combination, Stavudine, Lamivudine, RNA, Viral, Anti-HIV Agents, Viral Load
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Indinavir sulfateDrug
LamivudineDrug
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 startJun 1996
- Primary completionDec 1997
- Study completionDec 1997
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 80 participants
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002371
- Sponsor's protocol ID
- 244B
- Other IDs
- AI455-048
- Status last verified
- Apr 2011
- First submitted
- 2 Nov 1999
- Last updated
- 4 May 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Double-Blind Study of Safety, Virologic and Immunological Effects of Stavudine Plus Lamivudine (3TC) Versus Zidovudine Plus Lamivudine in HIV-Infected Subjects Following At Least Six Months of Zidovudine Therapy
- ClinicalTrials.gov ID
- NCT00002371
- Acronym / sponsor ID
- 244B
- Conditions
- HIV Infections
- Keywords
- HIV-1, Drug Therapy, Combination, Stavudine, Lamivudine, RNA, Viral, Anti-HIV Agents, Viral Load
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- Jun 1996
- Primary completion
- Dec 1997 (actual)
- Study completion
- Dec 1997 (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 the magnitude and durability of the reduction in plasma HIV RNA in the two treatment groups over the first 12 weeks of treatment. To determine the safety of each of the two treatment groups.
Detailed description
Patients will be randomized to either Stavudine (d4T) + Lamivudine (3TC) + Zidovudine placebo or Zidovudine (ZDV) + Lamivudine + Stavudine placebo. Patients whose plasma HIV RNA levels remain >= 500 copies/ml after 8 weeks of blinded double combination therapy will have indinavir added to their treatment regimen at the week 12 visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- At least six months of prior cumulative ZDV therapy.
- Qualifying plasma HIV RNA count of >= 4 log10 copies/ml obtained within 2 weeks of randomization.
Key exclusion criteria (26 listed)
- Presence of newly diagnosed AIDS defining opportunistic infection requiring acute therapy at time of enrollment.
- Intractable diarrhea (>= 6 loose stools/day for >= 7 consecutive days).
- Signs and symptoms of bilateral peripheral neuropathy >= grade 2 at the time of screening.
- Inability to tolerate oral medication.
- Any other clinical conditions that in the opinion of the investigator, would make the patient unsuitable for study or unable to comply with the dosing requirements.
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 |
|---|---|---|
| Indinavir sulfate | Drug | – |
| Lamivudine | Drug | – |
| 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 4 May 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.
8 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Indinavir sulfate, Lamivudine and Stavudine in people with HIV Infections, run by Bristol-Myers Squibb at 8 sites in 3 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 3 inclusion and 26 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 4 May 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States, Canada, 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.
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.
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 4 May 2011.