HIV InfectionsPhase 4NCT00312754
A Phase IV Study of BMS-232632 in HIV+ Patients With Metabolic Syndrome
A Phase 4 study testing Atazanavir in people with HIV Infections, run by Bristol-Myers Squibb at 6 sites in France.
Trial summary
The purpose of this clinical research study is to learn if BMS-232632 administered as Atazanavir/ritonavir (ATV/RTV) is superior to an anti-retroviral regimen including Lopinavir/ritonavir (LPV/RTV), as assessed by an increased brachial artery flow-mediated vasodilatation (FMD), in HIV-infected patients. 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
- How many people
- 70 participants
- Where
- 6 sitesFrance
- Study dates
- Jun 2005to Apr 2007
- Phase
- Phase 4
- 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
- Documented Metabolic Syndrome by at least 3 of the following parameters:
- Abdominal obesity, assessed by waist circumference (for men >103 cm, for women >88 cm).
- Triglycerides > 150 mg/dl.
- HDL cholestrol (for men <40 mg/dl, for women <50 mg/dl).
- Blood pressure > or equal to 130/85 mm Hg.
- Fasting serum glucose > or equal to 110 mg/dl.
- HIV RNA < 50 copies/mL.
- IP within 3 months prior to selection.
Who cannot join
- -Treated Metabolic Syndrom
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
France6 sites
Local Institution
Bobigny, 93009
Local Institution
Le Kremlin-Bicêtre, 94270
Local Institution
Paris, 75651
Local Institution
Paris, 75877
Local Institution
Paris, 75908
Local Institution
Paris, 75970
About this study
Official title: A Phase IV, One-arm, Open-label, Multicenter Study Evaluating Effect of Treatment Change to Atazanavir/Ritonavir on Brachial Endothelial Function of HIV Infected Patient Receiving Function in HIV Infected Patient Receiving Potent Antiretroviral Combination Therapy
The purpose of this clinical research study is to learn if BMS-232632 administered as Atazanavir/ritonavir (ATV/RTV) is superior to an anti-retroviral regimen including Lopinavir/ritonavir (LPV/RTV), as assessed by an increased brachial artery flow-mediated vasodilatation (FMD), in HIV-infected patients. The safety of this treatment will also be studied.
- Conditions
- HIV Infections
- Being tested
- Atazanavir
- 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
What is being measured
The primary outcome is the main question the study is designed to answer.
To demonstrate a significant increase in brachial artery FMD after a 24-week ATV/RTV treatment period.
Secondary outcomes (3)
The change in FMD from ref. value after a 12-wk ATV/RTV treatment period.
The proportion of pts w/ virologic rebound after a 24-wk ATV/RTV treatment period.
The proportion of pts w/ metabolic syndrome after a 24-wk ATV/RTV treament period.-
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2006 (estimated)
- Study startJun 2005
- Primary completionApr 2007
- Study completionApr 2007
Why it stopped: insufficient enrollment
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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Yacia Bennai, MD, Study director, 00 33 1 58 83 63 84
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00312754
- Sponsor's protocol ID
- AI424-108
- Other IDs
- Amazone
- Status last verified
- Sep 2016
- First submitted
- 14 Nov 2005
- Last updated
- 19 Sep 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IV, One-arm, Open-label, Multicenter Study Evaluating Effect of Treatment Change to Atazanavir/Ritonavir on Brachial Endothelial Function of HIV Infected Patient Receiving Function in HIV Infected Patient Receiving Potent Antiretroviral Combination Therapy
- ClinicalTrials.gov ID
- NCT00312754
- Acronym / sponsor ID
- AI424-108
- Conditions
- HIV Infections
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: insufficient enrollment
- Enrolment
- 70 participants
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- Jun 2005
- Primary completion
- Apr 2007 (actual)
- Study completion
- Apr 2007 (actual)
- First posted
- 11 Apr 2006 (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 clinical research study is to learn if BMS-232632 administered as Atazanavir/ritonavir (ATV/RTV) is superior to an anti-retroviral regimen including Lopinavir/ritonavir (LPV/RTV), as assessed by an increased brachial artery flow-mediated vasodilatation (FMD), in HIV-infected patients. The safety of this treatment will also be studied.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Documented Metabolic Syndrome by at least 3 of the following parameters:
- Abdominal obesity, assessed by waist circumference (for men >103 cm, for women >88 cm).
- Triglycerides > 150 mg/dl.
- HDL cholestrol (for men <40 mg/dl, for women <50 mg/dl).
- Blood pressure > or equal to 130/85 mm Hg.
Key exclusion criteria (1 listed)
- -Treated Metabolic Syndrom
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 | – |
Primary outcome
To demonstrate a significant increase in brachial artery FMD after a 24-week ATV/RTV treatment period.
3 secondary outcomes
The change in FMD from ref. value after a 12-wk ATV/RTV treatment period.
The proportion of pts w/ virologic rebound after a 24-wk ATV/RTV treatment period.
The proportion of pts w/ metabolic syndrome after a 24-wk ATV/RTV treament period.-
Results and safety
The study was stopped early (reason given: insufficient enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2016.
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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.
Yacia Bennai, MD study director
00 33 1 58 83 63 84
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Atazanavir in people with HIV Infections, run by Bristol-Myers Squibb at 6 sites in France.
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 8 inclusion and 1 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: stopped early, as of the sponsor's last update on 19 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in France. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 was stopped early (reason given: insufficient enrollment). Results are not available in the source record.
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?
To demonstrate a significant increase in brachial artery FMD after a 24-week ATV/RTV treatment 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 19 Sep 2016.