HIV InfectionsPhase 2NCT00002240
Study of a New Protease Inhibitor, BMS-232632, in Combination With Other Anti-HIV Drugs
A Phase 2 study testing Atazanavir, Nelfinavir mesylate and Stavudine in people with HIV Infections, run by Bristol-Myers Squibb at 17 sites in 2 countries.
Trial summary
The purpose of this study is to evaluate a new protease inhibitor known as BMS-232632. This drug will be given in combination with 2 other anti-HIV drugs (stavudine and didanosine). 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?
- Atazanavir, Nelfinavir mesylate and Stavudine
- How many people
- Not given
- Where
- 17 sitesin 2 countries
- Study dates
- Mar 1999to Dec 2001
- Phase
- Phase 2
- 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 may be eligible for this study if they:
- Are HIV-positive.
- Have an HIV blood level between 2,000 and 200,000 copies/ml.
- Have a CD4 cell count of at least 100 cells/mm3.
- Are 18 years of age or older.
- Are available for follow-up for at least 48 weeks.
- Agree to use a barrier method of birth control (such as condoms) during the study.
Who cannot join
- Patients will not be eligible for this study if they:
- Have ever received anti-HIV (antiretroviral) treatment.
- Have an HIV-related opportunistic infection or condition at the time of study entry.
- Have primary HIV infection, meaning they have recently been infected.
- Have had severe diarrhea within the 30 days before study entry.
- Have hemophilia.
Show all 10Show fewer
- Have a history of pancreatitis, hepatitis, or a peripheral neuropathy.
- Are unable to tolerate oral medication.
- Are pregnant or breast-feeding.
- Abuse alcohol or drugs.
Trial locations and contacts
17 sites in 2 countries.
17 sites in 2 countries
United States16 sites
Albany Med College
Albany, New York, 12208
AIDS Research Consortium of Atlanta
Atlanta, Georgia, 30308
Clinsites / Sorra Research Ctr
Birmingham, Alabama, 35203
Univ of Alabama at Birmingham
Birmingham, Alabama, 35294
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, 60612
Case Western Reserve Univ
Cleveland, Ohio, 44106
Oak Lawn Physicians Group
Dallas, Texas, 75219
Univ of Texas Southwestern Med Ctr of Dallas
Dallas, Texas, 75235
Univ of Colorado / Health Science Ctr
Denver, Colorado, 80262
Univ TX Galveston Med Branch
Galveston, Texas, 77555
Beth Israel Med Ctr
New York, New York, 10003
Columbia Presbyterian Med Ctr
New York, New York, 10032
UCSD Treatment Ctr
San Diego, California, 92103
UCSF - San Francisco Gen Hosp
San Francisco, California, 94110
Washington Univ School of Medicine
St Louis, Missouri, 63108
ViRx / Dupont Circle Physicians Group
Washington D.C., District of Columbia, 20009
About this study
Official title: Evaluation of the Safety and Antiviral Efficacy of a Novel HIV-1 Protease Inhibitor, BMS-232632, Alone and in Combination With d4T and ddI as Compared to a Reference Combination Regimen
The purpose of this study is to evaluate a new protease inhibitor known as BMS-232632. This drug will be given in combination with 2 other anti-HIV drugs (stavudine and didanosine). The effectiveness of BMS-232632 against HIV infection will be compared to that of nelfinavir, a protease inhibitor that is already commonly prescribed.
Read the detailed description
Patients are randomized to receive one of two drug regimens: BMS-232632, ddI, and d4T or NFV, ddI, and d4T. Three different doses of BMS-232632 are used in this study. Randomization is stratified for HIV RNA level (less than 30,000 copies/ml versus 30,000 or greater copies/ml). Patients remain on their drug regimen for 48 weeks.
- Conditions
- HIV Infections
- Being tested
- Atazanavir, Nelfinavir mesylate, Stavudine, Didanosine
- Keywords
- Didanosine, Dose-Response Relationship, Drug, Drug Therapy, Combination, Stavudine, HIV Protease Inhibitors, Reverse Transcriptase Inhibitors, Anti-HIV Agents, Nelfinavir
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtazanavirDrug
Nelfinavir mesylateDrug
StavudineDrug
DidanosineDrug
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 startMar 1999
- Primary completionDec 2001
- Study completionDec 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)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 2
- Primary purpose
- Treatment
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002240
- Sponsor's protocol ID
- 302A
- Other IDs
- AI424-007
- Status last verified
- Apr 2011
- First submitted
- 2 Nov 1999
- Last updated
- 4 May 2011
- Results posted
- No
Publications
Piliero P, et al. AI424-007: Atazanavir: an HIV protease inhibitor (PI) that does not cause lipid elevations. International Symposium on Drugs Affecting Lipid Metabolism. 2001 Sept 9 - 12
Gatell JM, et al. AI424-007: Atazanavir (BMS-232632): Absence of serum lipid changes after 48 weeks of treatment in treatment-naive HIV-positive subjects (Trial AI424007). 8th European Conf on Clinical Aspects and Treatment of HIV Infection (8th ECCATHI). 2001 Oct 28 - 31 (abstract no 223)
Piliero P, et al. AI424-007: BMS-232632 - Clinical Trial AI424007: Safety, Efficacy of a Once-Daily Protease Inhibitor at 24 Weeks. 5th International Congress on Drug Therapy in HIV Infection. 2000 Octr 22 - 26
Sanne I, Piliero P, Wood R, Kelleher T, Cross A, Mongillo A, Schnittman S. AI424-007: Safety and Antiviral Efficacy of a Novel Once-Daily HIV-1 Protease Inhibitor BMS-232632: Preliminary Results from a Phase II Clinical Trial. 7th Conf Retroviruses and Opportunistic Infect. 2000 Jan 30-Feb 2 (abstract no 672)
Squires K, Gatell J, Piliero P, Sanne I, Wood R, Schnittman SM. AI424-007: 48-week safety and efficacy results from a phase II study of a once-daily HIV-1 protease inhibitor (PI), BMS-232632. 8th Conf Retro and Opportun Infect. 2001 Feb 4-8 (abstract no 15)
Sanne I, Piliero P, Wood R, Kelleher T, Cross A, Mongillo A, Schnittman S. AI424-007: Safety and Antiviral Efficacy of a Once-Daily HIV-1 Protease Inhibitor BMS-232632: 24 Week Results from a Phase II Clinical Trial. 40th Interscience Conf on Antimicrobial Agents and Chemotherapy. 2000 September 17-20 (abstract no 691)
Piliero P, Cahn P, Pantaleo G, Gatell JM, Squires K, Percival L, Sanne I, Wood R, Phanuphak P, Shelton S, Lazzarin A, Thiry A, Kelleher T, Giordano M, Schnittman SM. AI424-007: Atazanavir: A Once-Daily Protease Inhibitor with a Superior Lipid Profile-Results of Clinical Trials Beyond Week 48. 9th Conf on Retroviruses and Opportunistic Infect. 2002 Feb 24 - 28 (abstract no 706-T)
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
- Evaluation of the Safety and Antiviral Efficacy of a Novel HIV-1 Protease Inhibitor, BMS-232632, Alone and in Combination With d4T and ddI as Compared to a Reference Combination Regimen
- ClinicalTrials.gov ID
- NCT00002240
- Acronym / sponsor ID
- 302A
- Conditions
- HIV Infections
- Keywords
- Didanosine, Dose-Response Relationship, Drug, Drug Therapy, Combination, Stavudine, HIV Protease Inhibitors, Reverse Transcriptase Inhibitors, Anti-HIV Agents, Nelfinavir
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- Mar 1999
- Primary completion
- Dec 2001 (actual)
- Study completion
- Dec 2001 (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.
The purpose of this study is to evaluate a new protease inhibitor known as BMS-232632. This drug will be given in combination with 2 other anti-HIV drugs (stavudine and didanosine). The effectiveness of BMS-232632 against HIV infection will be compared to that of nelfinavir, a protease inhibitor that is already commonly prescribed.
Detailed description
Patients are randomized to receive one of two drug regimens: BMS-232632, ddI, and d4T or NFV, ddI, and d4T. Three different doses of BMS-232632 are used in this study. Randomization is stratified for HIV RNA level (less than 30,000 copies/ml versus 30,000 or greater copies/ml). Patients remain on their drug regimen for 48 weeks.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Are HIV-positive.
- Have an HIV blood level between 2,000 and 200,000 copies/ml.
- Have a CD4 cell count of at least 100 cells/mm3.
- Are 18 years of age or older.
- Are available for follow-up for at least 48 weeks.
Key exclusion criteria (10 listed)
- Have ever received anti-HIV (antiretroviral) treatment.
- Have an HIV-related opportunistic infection or condition at the time of study entry.
- Have primary HIV infection, meaning they have recently been infected.
- Have had severe diarrhea within the 30 days before study entry.
- Have hemophilia.
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 |
|---|---|---|
| Atazanavir | Drug | – |
| Nelfinavir mesylate | Drug | – |
| Stavudine | Drug | – |
| Didanosine | 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.
- BackgroundPiliero P, et al. AI424-007: Atazanavir: an HIV protease inhibitor (PI) that does not cause lipid elevations. International Symposium on Drugs Affecting Lipid Metabolism. 2001 Sept 9 - 12
- BackgroundGatell JM, et al. AI424-007: Atazanavir (BMS-232632): Absence of serum lipid changes after 48 weeks of treatment in treatment-naive HIV-positive subjects (Trial AI424007). 8th European Conf on Clinical Aspects and Treatment of HIV Infection (8th ECCATHI). 2001 Oct 28 - 31 (abstract no 223)
- BackgroundPiliero P, et al. AI424-007: BMS-232632 - Clinical Trial AI424007: Safety, Efficacy of a Once-Daily Protease Inhibitor at 24 Weeks. 5th International Congress on Drug Therapy in HIV Infection. 2000 Octr 22 - 26
- BackgroundSanne I, Piliero P, Wood R, Kelleher T, Cross A, Mongillo A, Schnittman S. AI424-007: Safety and Antiviral Efficacy of a Novel Once-Daily HIV-1 Protease Inhibitor BMS-232632: Preliminary Results from a Phase II Clinical Trial. 7th Conf Retroviruses and Opportunistic Infect. 2000 Jan 30-Feb 2 (abstract no 672)
- BackgroundSquires K, Gatell J, Piliero P, Sanne I, Wood R, Schnittman SM. AI424-007: 48-week safety and efficacy results from a phase II study of a once-daily HIV-1 protease inhibitor (PI), BMS-232632. 8th Conf Retro and Opportun Infect. 2001 Feb 4-8 (abstract no 15)
- BackgroundSanne I, Piliero P, Wood R, Kelleher T, Cross A, Mongillo A, Schnittman S. AI424-007: Safety and Antiviral Efficacy of a Once-Daily HIV-1 Protease Inhibitor BMS-232632: 24 Week Results from a Phase II Clinical Trial. 40th Interscience Conf on Antimicrobial Agents and Chemotherapy. 2000 September 17-20 (abstract no 691)
- BackgroundPiliero P, Cahn P, Pantaleo G, Gatell JM, Squires K, Percival L, Sanne I, Wood R, Phanuphak P, Shelton S, Lazzarin A, Thiry A, Kelleher T, Giordano M, Schnittman SM. AI424-007: Atazanavir: A Once-Daily Protease Inhibitor with a Superior Lipid Profile-Results of Clinical Trials Beyond Week 48. 9th Conf on Retroviruses and Opportunistic Infect. 2002 Feb 24 - 28 (abstract no 706-T)
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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.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
17 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Atazanavir, Nelfinavir mesylate and Stavudine in people with HIV Infections, run by Bristol-Myers Squibb at 17 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 10 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 17 sites in United States, Canada. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
On the ClinicalTrials.gov record for NCT00002240, which also lists 7 linked publications.
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.