HIV InfectionsNCT00002369
A Comparison of Epivir Plus Crixivan Combined With Zerit or Retrovir in HIV-Infected Patients Who Have Never Taken Anti-HIV Drugs
A study testing Indinavir sulfate, Lamivudine and Stavudine in people with HIV Infections, run by Bristol-Myers Squibb at 11 sites in 2 countries.
Trial summary
To evaluate the tolerance, and comparative virologic and immunologic effects of the two combination regimens. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- Indinavir sulfate, Lamivudine and Stavudine
- How many people
- 200 participants
- Where
- 11 sitesin 2 countries
- Study dates
- Start not givento not given
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients must have:
- Documented HIV infection.
- CD4 cell count of 200 - 700 cells/mm3.
Who cannot join
- Co-existing Condition:
- Patients with the following symptoms or conditions are excluded:
- AIDS defining condition within 1 month of study entry.
- Prior Medication:
- Excluded:
- Patients with any history of antiretroviral therapy treatment.
Trial locations and contacts
11 sites in 2 countries.
11 sites in 2 countries
United States9 sites
Advance Clinical Research
Atlanta, Georgia, 30327
Blackstock Family Health Ctr
Austin, Texas, 76751
Univ of Alabama at Birmingham
Birmingham, Alabama, 35294
Boston Univ Med Ctr Hosp / Evans - 556
Boston, Massachusetts, 02118
Community Research Initiative of New England
Brookline, Massachusetts, 02445
HIV Clinical Research Ctr
Fort Lauderdale, Florida, 33316
Louisiana State Univ Med Ctr / HIV Outpatient Clinic
New Orleans, Louisiana, 70112
Washington Univ School of Medicine
St Louis, Missouri, 63108
Infectious Disease Research Institute Inc
Tampa, Florida, 33614
Puerto Rico2 sites
Hosp Regional de Ponce - Area Vieja
Ponce, 00731
San Juan AIDS Program
Santurce, 00908
About this study
Official title: An Open Label, Randomized, Comparative Study of Zerit (d4T) + Epivir (3TC) + Crixivan Versus Retrovir (AZT) + Epivir (3TC) + Crixivan in HIV-Infected, Antiretroviral Naive Subjects With CD4 Cell Counts of 200 - 700 Cells/mm3 and HIV RNA Baseline Copy Number of >= 10,000 Copies/ml
To evaluate the tolerance, and comparative virologic and immunologic effects of the two combination regimens.
Read the detailed description
100 patients will be randomized to receive Zerit (Stavudine) + Epivir (Lamivudine) + Crixivan (Indinavir) and 100 patients will be randomized to receive Retrovir (Zidovudine) + Epivir (Lamivudine) + Crixivan (Indinavir).
Patients will be treated for 48 weeks.
- Conditions
- HIV Infections
- Being tested
- Indinavir sulfate, Lamivudine, Stavudine, Zidovudine
- Keywords
- Drug Therapy, Combination, Zidovudine, Stavudine, HIV Protease Inhibitors, CD4 Lymphocyte Count, Lamivudine, Indinavir, Reverse Transcriptase Inhibitors, 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)
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 N/A
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
- Enrolment
- 200 participants
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002369
- Sponsor's protocol ID
- 260A
- Other IDs
- BMS 001
- Status last verified
- Oct 2007
- First submitted
- 2 Nov 1999
- Last updated
- 2 Oct 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Randomized, Comparative Study of Zerit (d4T) + Epivir (3TC) + Crixivan Versus Retrovir (AZT) + Epivir (3TC) + Crixivan in HIV-Infected, Antiretroviral Naive Subjects With CD4 Cell Counts of 200 - 700 Cells/mm3 and HIV RNA Baseline Copy Number of >= 10,000 Copies/ml
- ClinicalTrials.gov ID
- NCT00002369
- Acronym / sponsor ID
- 260A
- Conditions
- HIV Infections
- Keywords
- Drug Therapy, Combination, Zidovudine, Stavudine, HIV Protease Inhibitors, CD4 Lymphocyte Count, Lamivudine, Indinavir, Reverse Transcriptase Inhibitors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- 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 evaluate the tolerance, and comparative virologic and immunologic effects of the two combination regimens.
Detailed description
100 patients will be randomized to receive Zerit (Stavudine) + Epivir (Lamivudine) + Crixivan (Indinavir) and 100 patients will be randomized to receive Retrovir (Zidovudine) + Epivir (Lamivudine) + Crixivan (Indinavir).
Patients will be treated for 48 weeks.
Study design
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Documented HIV infection.
- CD4 cell count of 200 - 700 cells/mm3.
Key exclusion criteria (6 listed)
- AIDS defining condition within 1 month of study entry.
- Patients with any history of antiretroviral therapy treatment.
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 2 Oct 2007.
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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.
11 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Indinavir sulfate, Lamivudine and Stavudine in people with HIV Infections, run by Bristol-Myers Squibb at 11 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 3 inclusion and 6 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 2 Oct 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 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?
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 2 Oct 2007.