HIV InfectionsPhase 3NCT00135395
A Phase IIIb Study Comparing Two Boosted Protease Inhibitor-based HAART Regimens in HIV-infected Patients Experiencing Their First Virologic Failure While Receiving an NNRTI-containing HAART Regimen
A Phase 3 study testing Atazanavir+ritonavir and Lopinavir+ritonavir in people with HIV Infections, run by Bristol-Myers Squibb at 53 sites in 2 countries.
Trial summary
The purpose of this study is to compare the anti-HIV efficacy, safety and effect of serum lipids of two boosted protease inhibitor-based HAART regimens (ARV/RTV v. LPV/RTV) in HIV-1 infected subjects who have experienced their first virologic failure while receiving a NNRTI-containing HAART regimen. 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 Lopinavir+ritonavir
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 53 sitesin 2 countries
- Study dates
- May 2004to Feb 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
- Patients ≥ 18 years of age infected with HIV
- Plasma HIV RNA ≥ 1000 copies/mL and CD4 cell count ≥ 50 cells/mm3
- Currently receiving a NNRTI-containing HAART regimen or not currently receiving a NNRTI-containing HAART regimen and have not been treated with an alternative regimen since the documented virologic failure (with genotype performed within 2 weeks of the discontinuation of the failing regimen and the genotype report is available)
- The failing NNRTI-containing regimen must be the patient's first virologic failure on treatment and contain a NNRTI and at least 2 NRTIs. The regimen must have been administered for at least 24 weeks and the patient must have documented virologic response to the regimen (HIV RNA < 400 c/mL)
Who cannot join
- Pregnancy or breastfeeding
- Reported virologic failure to two or more antiretroviral regimens
- Active AIDS-defined opportunistic infection or disease
- Proven or suspected acute hepatitis within 30 days prior to study entry
Trial locations and contacts
53 sites in 2 countries.
53 sites in 2 countries
United States52 sites
Local Institution
Atlanta, Georgia
Local Institution
Atlantis, Florida
Local Institution
Bakersfield, California
Local Institution
Berkley, Michigan
Local Institution
Boston, Massachusetts
Local Institution
Brooklyn, New York
Local Institution
Chicago, Illinois
Local Institution
Columbia, South Carolina
Local Institution
Dallas, Texas
Local Institution
Decatur, Georgia
Local Institution
East Orange, New Jersey
Local Institution
Fort Lauderdale, Florida
Local Institution
Galveston, Texas
Local Institution
Greenville, North Carolina
Local Institution
Hampton, Virginia
Local Institution
Harlingen, Texas
Local Institution
Hillsborough, New Jersey
Local Institution
Hobson City, Alabama
Local Institution
Houston, Texas
Local Institution
Huntersville, North Carolina
Local Institution
Indianapolis, Indiana
Local Institution
Jackson, Mississippi
Local Institution
Jacksonville, Florida
Local Institution
Jersey City, New Jersey
Local Institution
Las Vegas, Nevada
Local Institution
Little Rock, Arkansas
Local Institution
Los Angeles, California
Local Institution
Louisville, Kentucky
Local Institution
Miami, Florida
Local Institution
Miami Beach, Florida
Local Institution
Montgomery, Alabama
Local Institution
Mount Vernon, New York
Local Institution
New Orleans, Louisiana
Local Institution
New York, New York
Local Institution
North Miami, Florida
Local Institution
Norwalk, Connecticut
Local Institution
Oklahoma City, Oklahoma
Local Institution
Orlando, Florida
Local Institution
Philadelphia, Pennsylvania
Local Institution
Phoenix, Arizona
Local Institution
Plantation, Florida
Local Institution
Safety Harbor, Florida
Local Institution
San Francisco, California
Local Institution
San Mateo, California
Local Institution
Springfield, Massachusetts
Local Institution
St Louis, Missouri
Local Institution
Tampa, Florida
Local Institution
Tarzana, California
Local Institution
Valhalla, New York
Local Institution
Washington D.C., District of Columbia
Local Institution
West Hollywood, California
Local Institution
Winston-Salem, North Carolina
About this study
Official title: A Phase IIIb, Open -Label, Randomized Multi-center Study Comparing the Antiviral Efficacy, Safety, and Effect on Serum Lipids of Atazanavir/Ritonavir Versus Lopinavir/Ritonavir, in Combination With Two Nucleoside or Nucleotide Reverse Transcriptase Inhibitors (NRTIs) in HIV-1 Infected Subjects Experiencing Their First Virologic Failure While Receiving a NNRTI-containing HAART Regimen.
The purpose of this study is to compare the anti-HIV efficacy, safety and effect of serum lipids of two boosted protease inhibitor-based HAART regimens (ARV/RTV v. LPV/RTV) in HIV-1 infected subjects who have experienced their first virologic failure while receiving a NNRTI-containing HAART regimen.
- Conditions
- HIV Infections
- Being tested
- Atazanavir+ritonavir, Lopinavir+ritonavir
- Keywords
- HIV/AIDS, Treatment Experienced
- Medical subject headings
- HIV Infections, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atazanavir+ritonavirDrug
Also called Reyataz
Capsules, Oral, 300mg/100mg, once daily, 24 weeks.
Lopinavir+ritonavirDrug
Capsules, Oral, 800mg/200mg, twice daily, 24 weeks.
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | Not described Receives: Drug: Atazanavir+ritonavir |
| B | Active comparator | Not described Receives: Drug: Lopinavir+ritonavir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Co-Primary Outcomes in this study 1)Viral load reduction from baseline through Week 24 2)Change in lipids from baseline at Week 12
Secondary outcomes (1)
Viral load reduction from baseline at Weeks 48,72,96;Subjects with HIV RNA<50 and <400 c/mL at Weeks 24,48,72 & 96;Patterns of resistance;Safety and tolerability through Week 96 including fasting lipid values;Adherence at Weeks 4,12,24,48,72 & 96.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2005 (estimated)
- Study startMay 2004
- Primary completionFeb 2006
- Study completionFeb 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
- Single group
- Masking
- None (open label)
- Enrolment
- 200 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
- NCT00135395
- Sponsor's protocol ID
- AI424-103
- Status last verified
- Jul 2008
- First submitted
- 25 Aug 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 Comparing the Antiviral Efficacy, Safety, and Effect on Serum Lipids of Atazanavir/Ritonavir Versus Lopinavir/Ritonavir, in Combination With Two Nucleoside or Nucleotide Reverse Transcriptase Inhibitors (NRTIs) in HIV-1 Infected Subjects Experiencing Their First Virologic Failure While Receiving a NNRTI-containing HAART Regimen.
- ClinicalTrials.gov ID
- NCT00135395
- Acronym / sponsor ID
- AI424-103
- Conditions
- HIV Infections
- Keywords
- HIV/AIDS, Treatment Experienced
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- May 2004
- Primary completion
- Feb 2006 (actual)
- Study completion
- Feb 2006 (actual)
- First posted
- 26 Aug 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.
The purpose of this study is to compare the anti-HIV efficacy, safety and effect of serum lipids of two boosted protease inhibitor-based HAART regimens (ARV/RTV v. LPV/RTV) in HIV-1 infected subjects who have experienced their first virologic failure while receiving a NNRTI-containing HAART regimen.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Drug: Atazanavir+ritonavir |
| B | Active comparator | Drug: Lopinavir+ritonavir |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients ≥ 18 years of age infected with HIV
- Plasma HIV RNA ≥ 1000 copies/mL and CD4 cell count ≥ 50 cells/mm3
- Currently receiving a NNRTI-containing HAART regimen or not currently receiving a NNRTI-containing HAART regimen and have not been treated with an alternative regimen since the documented virologic failure (with genotype performed within 2 weeks of the discontinuation of the failing regimen and the genotype report is available)
- The failing NNRTI-containing regimen must be the patient's first virologic failure on treatment and contain a NNRTI and at least 2 NRTIs. The regimen must have been administered for at least 24 weeks and the patient must have documented virologic response to the regimen (HIV RNA < 400 c/mL)
Key exclusion criteria (4 listed)
- Pregnancy or breastfeeding
- Reported virologic failure to two or more antiretroviral regimens
- Active AIDS-defined opportunistic infection or disease
- Proven or suspected acute hepatitis within 30 days prior to study entry
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+ritonavirAlso: ReyatazCapsules, Oral, 300mg/100mg, once daily, 24 weeks. | Drug | A |
| Lopinavir+ritonavirCapsules, Oral, 800mg/200mg, twice daily, 24 weeks. | Drug | B |
Primary outcome
Co-Primary Outcomes in this study 1)Viral load reduction from baseline through Week 24 2)Change in lipids from baseline at Week 12
1 secondary outcome
Viral load reduction from baseline at Weeks 48,72,96;Subjects with HIV RNA<50 and <400 c/mL at Weeks 24,48,72 & 96;Patterns of resistance;Safety and tolerability through Week 96 including fasting lipid values;Adherence at Weeks 4,12,24,48,72 & 96.
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
53 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 and Lopinavir+ritonavir in people with HIV Infections, run by Bristol-Myers Squibb at 53 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 4 inclusion and 4 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 53 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.
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?
Co-Primary Outcomes in this study 1)Viral load reduction from baseline through Week 24 2)Change in lipids from baseline at Week 12. 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.