HIV InfectionsPhase 3NCT00120393
Study of HIV Patients With Undetectable Viral Load and Abnormal Lipids Switching to Atazanavir/Ritonavir
A Phase 3 study testing atazanavir/ritonavir +2 NRTIs (immediate Switch Group) and LPV/r +2 NRTIs (Delayed/optional Switch Group) in people with HIV Infections, run by Bristol-Myers Squibb at 14 sites in 2 countries.
Trial summary
Patients with HIV who are virologically suppressed on a lopinavir/ritonavir combination highly active antiretroviral therapy (HAART) regimen but with elevated non-HDL cholesterol are randomized to remain on lopinavir/ritonavir or change to atazanavir/ritonavir in combination with current nucleoside reverse… 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 +2 NRTIs (immediate Switch Group) and LPV/r +2 NRTIs (Delayed/optional Switch Group)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 192 participants
- Where
- 14 sitesin 2 countries
- Study dates
- Jan 2004to May 2006
- 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
- HIV positive
- LPV/RTV-based HAART for at least 6 months
- HIV-1 RNA less than 50c/mL (confirmed)
- Non-HDL higher than 160 mg/dL
- CD4 of at least 50 cells/mL
Who cannot join
- Use of lipid-lowering agents
Trial locations and contacts
14 sites in 2 countries.
14 sites in 2 countries
United States12 sites
Local Institution
Bakersfield, California
Local Institution
Boston, Massachusetts
Local Institution
Cincinnati, Ohio
Local Institution
Columbia, South Carolina
Local Institution
Dallas, Texas
Local Institution
Los Angeles, California
Local Institution
Miami, Florida
Local Institution
New York, New York
Local Institution
Philadelphia, Pennsylvania
Local Institution
Phoenix, Arizona
Local Institution
Portland, Oregon
Local Institution
San Francisco, California
Canada2 sites
Local Institution
Hamilton, Ontario
Local Institution
Montreal, Quebec
About this study
Official title: A Phase IIIB, Open-label, Randomized, Multi-center Study Evaluating the Effect on Serum Lipids Following a Switch to ATV/r in HIV-1 Infected Subjects Who Have Achieved Virologic Suppression on a LPV/r Based Regimen.
Patients with HIV who are virologically suppressed on a lopinavir/ritonavir combination highly active antiretroviral therapy (HAART) regimen but with elevated non-HDL cholesterol are randomized to remain on lopinavir/ritonavir or change to atazanavir/ritonavir in combination with current nucleoside reverse transcriptase inhibitors (NRTIs).
- Conditions
- HIV Infections
- Being tested
- atazanavir/ritonavir +2 NRTIs (immediate Switch Group), LPV/r +2 NRTIs (Delayed/optional Switch Group)
- Keywords
- Treatment Experienced
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
atazanavir/ritonavir +2 NRTIs (immediate Switch Group)Drug
Also called Reyataz
Capsules, Oral, ATV 300mg/RTV 100mg + 2 NRTIs, QD, 48 weeks.
LPV/r +2 NRTIs (Delayed/optional Switch Group)Drug
Capsules, Oral, LPV 400mg/RTV 100mg +2 NRTIs, BID, 24 weeks then option to switch to ATV arm or stay until 48 weeks.
| Study group | Role | What they receive |
|---|---|---|
| G1 | Active comparator | Not described Receives: Drug: atazanavir/ritonavir +2 NRTIs (immediate Switch Group) |
| G2 | Active comparator | Not described Receives: Drug: LPV/r +2 NRTIs (Delayed/optional Switch Group) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the Week 12 percent change from baseline in fasting non-HDL cholesterol between subjects who are switched to an ATV/RTV-containing regimen and those who continue on a LPV/RTV based regimen.
Secondary outcomes (7)
Mean percent change in fasting non-HDL cholesterol at Weeks 24 and 48.
Mean change in cholesterol measures at Weeks 12, 24 and 48.
Mean percent changes from baseline in fasting glucose and insulin at Weeks 12, 24 and 48.
The proportion of subjects receiving lipid lowering therapy at Weeks 24 and 48.
The proportion of subjects with LDL cholesterol less than 130mg/dL at Weeks 12, 24 and 48.
The proportion of subjects with non-HDL cholesterol less than 160mg/dL at Weeks 12, 24 and 48.
The frequency and severity of all clinical and laboratory AEs and discontinue for AEs.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2005 (estimated)
- Study startJan 2004
- Primary completionMay 2006
- Study completionMay 2006
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
- Crossover
- Masking
- None (open label)
- Enrolment
- 192 participants (estimated)
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
- NCT00120393
- Sponsor's protocol ID
- AI424-100
- Status last verified
- Jul 2009
- First submitted
- 12 Jul 2005
- Last updated
- 5 Feb 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IIIB, Open-label, Randomized, Multi-center Study Evaluating the Effect on Serum Lipids Following a Switch to ATV/r in HIV-1 Infected Subjects Who Have Achieved Virologic Suppression on a LPV/r Based Regimen.
- ClinicalTrials.gov ID
- NCT00120393
- Acronym / sponsor ID
- AI424-100
- Conditions
- HIV Infections
- Keywords
- Treatment Experienced
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 192 participants (estimated)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- Jan 2004
- Primary completion
- May 2006 (actual)
- Study completion
- May 2006 (actual)
- First posted
- 18 Jul 2005 (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.
Patients with HIV who are virologically suppressed on a lopinavir/ritonavir combination highly active antiretroviral therapy (HAART) regimen but with elevated non-HDL cholesterol are randomized to remain on lopinavir/ritonavir or change to atazanavir/ritonavir in combination with current nucleoside reverse transcriptase inhibitors (NRTIs).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| G1 | Active comparator | Drug: atazanavir/ritonavir +2 NRTIs (immediate Switch Group) |
| G2 | Active comparator | Drug: LPV/r +2 NRTIs (Delayed/optional Switch Group) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- HIV positive
- LPV/RTV-based HAART for at least 6 months
- HIV-1 RNA less than 50c/mL (confirmed)
- Non-HDL higher than 160 mg/dL
- CD4 of at least 50 cells/mL
Key exclusion criteria (1 listed)
- Use of lipid-lowering agents
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/ritonavir +2 NRTIs (immediate Switch Group)Also: ReyatazCapsules, Oral, ATV 300mg/RTV 100mg + 2 NRTIs, QD, 48 weeks. | Drug | G1 |
| LPV/r +2 NRTIs (Delayed/optional Switch Group)Capsules, Oral, LPV 400mg/RTV 100mg +2 NRTIs, BID, 24 weeks then option to switch to ATV arm or stay until 48 weeks. | Drug | G2 |
Primary outcome
To compare the Week 12 percent change from baseline in fasting non-HDL cholesterol between subjects who are switched to an ATV/RTV-containing regimen and those who continue on a LPV/RTV based regimen.
7 secondary outcomes
Mean percent change in fasting non-HDL cholesterol at Weeks 24 and 48.
Mean change in cholesterol measures at Weeks 12, 24 and 48.
Mean percent changes from baseline in fasting glucose and insulin at Weeks 12, 24 and 48.
The proportion of subjects receiving lipid lowering therapy at Weeks 24 and 48.
The proportion of subjects with LDL cholesterol less than 130mg/dL at Weeks 12, 24 and 48.
The proportion of subjects with non-HDL cholesterol less than 160mg/dL at Weeks 12, 24 and 48.
The frequency and severity of all clinical and laboratory AEs and discontinue for AEs.
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 5 Feb 2010.
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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
14 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing atazanavir/ritonavir +2 NRTIs (immediate Switch Group) and LPV/r +2 NRTIs (Delayed/optional Switch Group) in people with HIV Infections, run by Bristol-Myers Squibb at 14 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 5 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: finished, as of the sponsor's last update on 5 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 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 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.
What does the primary outcome measure?
To compare the Week 12 percent change from baseline in fasting non-HDL cholesterol between subjects who are switched to an ATV/RTV-containing regimen and those who continue on a LPV/RTV based regimen.. 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 5 Feb 2010.