HIV InfectionsPhase 2NCT00004584
Safety and Effectiveness of a New Protease Inhibitor, BMS-232632, in HIV-Positive Patients Who Have Received Previous Treatment
A Phase 2 study testing Atazanavir, Ritonavir and Saquinavir in people with HIV Infections, run by Bristol-Myers Squibb at 38 sites in 5 countries.
Trial summary
The purpose of this study is to look at the safety and effectiveness of an experimental protease inhibitor (a type of anti-HIV drug) called BMS-232632. Doctors will compare an anti-HIV drug combination that includes BMS-232632 to a drug combination that includes ritonavir. 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, Ritonavir and Saquinavir
- How many people
- Not given
- Where
- 38 sitesin 5 countries
- Study dates
- Dec 1999to Jan 2002
- 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 a viral load (level of HIV in the blood) of at least 2,000 copies/ml.
- Have a CD4 count of at least 100 cells/mm3 (or at least 75 cells/mm3 in patients who have never had an AIDS-defining illness).
- Are currently receiving an anti-HIV drug combination that includes a protease inhibitor or nonnucleoside reverse transcriptase inhibitor (NNRTI), and they have been taking this drug combination for at least 24 weeks. They must have responded well to this treatment at first (their viral load decreased) but are currently experiencing an increase in viral load.
- Will most likely respond well to the study drugs, as shown by the results of a lab test.
Show all 9Show fewer
- Are at least 18 years old.
- Agree to use effective barrier methods of birth control (such as condoms).
- Are available for follow-up for at least 48 weeks.
Who cannot join
- Patients will not be eligible for this study if they:
- Have a newly diagnosed opportunistic (HIV-related) infection requiring treatment.
- Have only recently become HIV positive.
- Abuse alcohol or drugs.
- Have severe diarrhea within 30 days of study entry.
- Have hemophilia.
Show all 11Show fewer
- Have a history of pancreatitis.
- Have hepatitis within 30 days of study entry.
- Have peripheral neuropathy (a painful condition affecting the nervous system).
- Are unable to take medications by mouth.
- Are pregnant or breast-feeding.
Trial locations and contacts
38 sites in 5 countries.
38 sites in 5 countries
United States20 sites
Albany Med College
Albany, New York, 12208
Sorra Research Ctr / Med Forum
Birmingham, Alabama, 35203
Univ Hosps of Cleveland
Cleveland, Ohio, 44106
Community Research Initiative of South Florida
Coral Gables, Florida, 33146
Univ of Texas Southwestern Med Ctr of Dallas
Dallas, Texas, 75235
Infectious Disease Specialists of Atlanta
Decatur, Georgia, 30033
Texas Tech Health Sciences Ctr
El Paso, Texas, 79905
HIV Clinical Research
Fort Lauderdale, Florida, 33316
Houston Clinical Research Network / Div of Montrose Clinic
Houston, Texas, 77006
AIDS Healthcare Foundation
Los Angeles, California, 90027
Vanderbilt Univ Med Ctr
Nashville, Tennessee, 37212
Yale Univ School of Medicine / AIDS Program
New Haven, Connecticut, 06510
Louisiana State Univ Med Ctr / HIV Outpatient Clinic
New Orleans, Louisiana, 70112
St Vincents Hosp / Clinical Research Program
New York, New York, 10011
Robert Scott MD
Oakland, California, 94609
The Research and Education Group
Portland, Oregon, 97210
Univ of California - Davis Med Ctr / CARES
Sacramento, California, 95817
Infectious Disease Research Institute
Tampa, Florida, 33614
Avalar Medical Group
Tarzana, California, 91356
Julio Arroyo
West Columbia, South Carolina, 29169
France7 sites
Hopital Pellegrin Tripode
Bordeaux
Hopital De L'Hotel Dieu
Nantes
Hopital De L'Archet 1
Nice
Srev Du Pr Gentilini
Paris
Hopital De Haut Leveque
Pessac
Hospital Gustave Dron
Tourcoing
Hopital Paul Brousse
Villejuif
Italy5 sites
Reparto Malattie Infettive
Antella
Clinical Malattie Infettive
Milan
Ospedale Luigi Cacco Moroni
Milan
Clinical Malattie Infettive / Univ Modena
Modena
Ospedale degli Infermi
Rimini
Canada3 sites
Montreal Chest Institute
Montreal, Quebec
Ottawa General Hospital
Ottawa, Ontario
Toronto Hosp
Toronto, Ontario
Germany3 sites
Brennerstr 71
Hamburg
Georg-Str 46
Hanover
Praxisgemeinschaft
Munich
About this study
Official title: Safety and Antiviral Efficacy of a Novel HIV-1 Protease Inhibitor, BMS-232632, in Combination Regimen(s) as Compared to a Reference Combination Regimen(s) in Antiretroviral-Experienced HIV-Infected Subjects
The purpose of this study is to look at the safety and effectiveness of an experimental protease inhibitor (a type of anti-HIV drug) called BMS-232632. Doctors will compare an anti-HIV drug combination that includes BMS-232632 to a drug combination that includes ritonavir.
Read the detailed description
This is a three-arm study; patients are randomized to receive BMS-232632 at two different doses or RTV in combination with SQV and two nucleoside analogues over 48 weeks. Randomization is stratified for baseline phenotypic sensitivity.
- Conditions
- HIV Infections
- Being tested
- Atazanavir, Ritonavir, Saquinavir
- Keywords
- Dose-Response Relationship, Drug, Drug Therapy, Combination, HIV Protease Inhibitors, Ritonavir, Saquinavir, Reverse Transcriptase Inhibitors, Anti-HIV Agents
- 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
RitonavirDrug
SaquinavirDrug
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 startDec 1999
- Primary completionJan 2002
- Study completionJan 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00004584
- Sponsor's protocol ID
- 302B
- Other IDs
- AI424-009
- Status last verified
- Apr 2011
- First submitted
- 10 Feb 2000
- Last updated
- 4 May 2011
- Results posted
- No
Publications
Haas DW, Zala C, Schrader S,Thiry A, McGovern R, Schnittman S. AI424009: Atazanavir plus Saquinavir once daily favorably affects total cholesterol (TC), fasting triglyceride (TG), and fasting LDL cholesterol (LDL) profiles in patients failing prior therapy week 48. 9th Conf on Retroviruses and Opportunistic Infect. 2002 Feb 24-28 (abstract no 42)
Haas DW, Zala C, Schrader S,Thiry A, McGovern R, Schnittman S. AI424-009: Once-Daily Atazanavir plus Saquinavir favorably affects total cholesterol and fasting triglycerides in patients failing prior PI therapy study BMS-009,week 24. 41st Annual Conf on Antimicrobial Agents and Chemotherapy. 2001 Feb 16-19 (abstract no LB-16)
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
- Safety and Antiviral Efficacy of a Novel HIV-1 Protease Inhibitor, BMS-232632, in Combination Regimen(s) as Compared to a Reference Combination Regimen(s) in Antiretroviral-Experienced HIV-Infected Subjects
- ClinicalTrials.gov ID
- NCT00004584
- Acronym / sponsor ID
- 302B
- Conditions
- HIV Infections
- Keywords
- Dose-Response Relationship, Drug, Drug Therapy, Combination, HIV Protease Inhibitors, Ritonavir, Saquinavir, Reverse Transcriptase Inhibitors, Anti-HIV Agents
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- Dec 1999
- Primary completion
- Jan 2002 (actual)
- Study completion
- Jan 2002 (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 look at the safety and effectiveness of an experimental protease inhibitor (a type of anti-HIV drug) called BMS-232632. Doctors will compare an anti-HIV drug combination that includes BMS-232632 to a drug combination that includes ritonavir.
Detailed description
This is a three-arm study; patients are randomized to receive BMS-232632 at two different doses or RTV in combination with SQV and two nucleoside analogues over 48 weeks. Randomization is stratified for baseline phenotypic sensitivity.
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 (9 listed)
- Are HIV-positive.
- Have a viral load (level of HIV in the blood) of at least 2,000 copies/ml.
- Have a CD4 count of at least 100 cells/mm3 (or at least 75 cells/mm3 in patients who have never had an AIDS-defining illness).
- Are currently receiving an anti-HIV drug combination that includes a protease inhibitor or nonnucleoside reverse transcriptase inhibitor (NNRTI), and they have been taking this drug combination for at least 24 weeks. They must have responded well to this treatment at first (their viral load decreased) but are currently experiencing an increase in viral load.
- Will most likely respond well to the study drugs, as shown by the results of a lab test.
Key exclusion criteria (11 listed)
- Have a newly diagnosed opportunistic (HIV-related) infection requiring treatment.
- Have only recently become HIV positive.
- Abuse alcohol or drugs.
- Have severe diarrhea within 30 days of 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 | – |
| Ritonavir | Drug | – |
| Saquinavir | 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.
- BackgroundHaas DW, Zala C, Schrader S,Thiry A, McGovern R, Schnittman S. AI424009: Atazanavir plus Saquinavir once daily favorably affects total cholesterol (TC), fasting triglyceride (TG), and fasting LDL cholesterol (LDL) profiles in patients failing prior therapy week 48. 9th Conf on Retroviruses and Opportunistic Infect. 2002 Feb 24-28 (abstract no 42)
- BackgroundHaas DW, Zala C, Schrader S,Thiry A, McGovern R, Schnittman S. AI424-009: Once-Daily Atazanavir plus Saquinavir favorably affects total cholesterol and fasting triglycerides in patients failing prior PI therapy study BMS-009,week 24. 41st Annual Conf on Antimicrobial Agents and Chemotherapy. 2001 Feb 16-19 (abstract no LB-16)
Related trials for HIV Infections
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
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.
38 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Atazanavir, Ritonavir and Saquinavir in people with HIV Infections, run by Bristol-Myers Squibb at 38 sites in 5 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 9 inclusion and 11 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 38 sites in United States, France, Italy, Canada, Germany. 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 NCT00004584, which also lists 2 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.