HIV InfectionsPhase 3NCT00028301
Atazanavir Versus Lopinavir/Ritonavir (LPV/RTV) in Patients Who Have Not Had Success With Protease Inhibitor-Containing HAART Regimen(s)
A Phase 3 study testing Atazanavir and Lopinavir/Ritonavir in people with HIV Infections, run by Bristol-Myers Squibb at 97 sites in 16 countries.
Trial summary
This study will compare 2 treatments in the way they affect cholesterol levels and the amount of HIV in the blood. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- Atazanavir and Lopinavir/Ritonavir
- How many people
- Not given
- Where
- 97 sitesin 16 countries
- Study dates
- Feb 2001to Sep 2003
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients may be eligible for this study if they:
- Are receiving a PI-containing highly active antiretroviral therapy (HAART) for at least 12 weeks.
- Have a viral load of 1,000 or more copies/ml within 4 weeks of screening and within 4 weeks prior to randomization.
- Have 2 CD4 cell counts of 50 or more cells/mm3 at least 96 hours apart and within 4 weeks before randomization.
- Are at least 16 years old.
- Have a documented virologic response to at least 1 HAART regimen.
Show all 10Show fewer
- Have phenotypic sensitivity to at least 2 of the following: ddl, d4T, ZDV, 3TC, ABC.
- Have phenotypic sensitivity to atazanavir and LPV/RTV.
- Use effective barrier methods of birth control.
- Will be available for 48 weeks.
Who cannot join
- Patients will not be eligible for this study if they:
- Have taken 2 or more PIs and had virologic failure.
- Have taken atazanavir or LPV/RTV.
- Have an HIV-related infection (within 30 days) or any medical condition requiring treatment at the time of enrollment.
- Have had acute hepatitis in the 30 days prior to study entry.
- Have received certain drugs within 3 months of study start or expect to need them at time of enrollment.
Show all 16Show fewer
- Abuse alcohol or drugs in a way that would interfere with the study.
- Have very bad diarrhea within 30 days prior to study entry.
- Are pregnant or breast-feeding.
- Have a history of hemophilia.
- Use lipid-lowering drugs (within the previous 30 days).
- Have cardiomyopathy or symptoms of other heart disease.
- Cannot take medicine by mouth.
- Have any other condition that would interfere with the study.
- Have pancreatitis, if choosing ddI as part of NRTI pair.
- Have bilateral peripheral neuropathy at time of screening, if choosing ddI or or d4T as part of the NRTI pair.
Trial locations and contacts
97 sites in 16 countries.
97 sites in 16 countries
United States38 sites
Albany Med College
Albany, New York, 12208
IDC Research Initiative
Altamonte Springs, Florida, 32701
Larry Bush
Atlantis, Florida, 33462
East Bay AIDS Ctr
Berkeley, California, 94705
Cooper Green Hosp
Birmingham, Alabama, 35233
Sky Blue
Boise, Idaho, 83704
Beacon Clinic / Boulder Community Hosp
Boulder, Colorado, 80304
Community Research Initiative
Brookline, Massachusetts, 02445
Erie County Med Ctr
Buffalo, New York, 14215
Univ of South Carolina School of Medicine
Columbia, South Carolina, 29203
North Texas Center for AIDS & Clinical Research
Dallas, Texas, 75208
Nicholas Bellos
Dallas, Texas, 75246
Infectious Disease Specialists of Atlanta
Decatur, Georgia, 30033
VAMC New Jersey Healthcare System
East Orange, New Jersey, 07018
Community Health Care
Fort Lauderdale, Florida, 33306
Univ of Hawaii
Honolulu, Hawaii, 96816
Houston Clinical Research Network
Houston, Texas, 77006
Infectious Diseases Associates of Houston
Houston, Texas, 77030
Jemsek Clinic
Huntersville, North Carolina, 28078
Infectious Disease of Indiana
Indianapolis, Indiana, 46218
Univ of Kentucky Med Ctr
Lexington, Kentucky, 40536
North Shore Univ Hosp
Manhasset, New York, 11030
South Beach Medical Associates
Miami Beach, Florida, 33160
North Jersey Community Research Initiative
Newark, New Jersey, 071032842
Florida ID Group
Orlando, Florida, 32801
Mark Watkins
Philadelphia, Pennsylvania, 19107
Phoenix Body Positive
Phoenix, Arizona, 85006
Oregon Health Sciences Univ
Portland, Oregon, 97201
Research & Education Group
Portland, Oregon, 97209
Steven Zell
Reno, Nevada, 89502
Community Health Network
Rochester, New York, 14620
Saint Francis Mem Hosp / HIV Care Unit
San Francisco, California, 94109
Kaiser Foundation Hospital
San Francisco, California, 94118
San Francisco Veterans Administration Med Ctr
San Francisco, California, 94121
Southampton Healthcare Inc
St Louis, Missouri, 63139
Harbor UCLA Med Ctr
Torrance, California, 90502
Univ of Kansas School of Medicine
Wichita, Kansas, 672143124
Univ of Massachusetts
Worcester, Massachusetts, 01655
Italy9 sites
Ospedale S Orsola
Bologna
Immunoligia Universita Cagliari
Cagliari
Reparto di Malattie Infettive
Corso Svizzera
Ospedale Luigi Sacco Cargnel
Milan
Ospedale S Raffaele
Milan
Ospedale degli Infermi
Rimini
Cat All Immun Clin
Roma
Ospedale Amedeo de Savoia
Torino
Ospedale Amedeo di Savoia
Torino
Spain8 sites
Hosp Clinic
Barcelona
Hospital Germans Trias I Pujol
Barcelona
Hosp de Basurto / Enfermedades Infecciosas
Bilboa
Hosp Reina Sofia
Córdoba
Hosp Carlos III
Madrid
Hosp Ramon y Cajal
Madris
Hosp Nuestra Senora de Covadonga
Oviedo
Hosp Virgen Del Rocio
Seville
Argentina5 sites
Claudia Rodriguez MD
Buenos Aires
Elida Pallone MD
Buenos Aires
Fundacion Huesped
Buenos Aires
Hospital Italiano
Buenos Aires
CAICI
Rosario Santa Fe
Belgium5 sites
Inst of Tropical Medicine
Antwerp
CHU Saint Pierre
Brussels
Cliniques Universitaires Saint Luc
Brussels
University Hospital Gent
Ghent
Domaine Universitaire Du SART-TILMAN
Liège
France5 sites
Hopital Hotel Dieu de Lyon
Lyon
CHU De Bicetre
Paris
Hopital Cochin - Port Royal
Paris
Services des Maladies Infectieuses
Paris
Hopital Gustave Dron
Tourcoing
Australia4 sites
Alfred Hosp
Prahan
Prahran Market Clinic
South Yarra
Saint Vincent's Hosp Med Centre
Sydney
Taylors Square Clinic
Sydney
Canada4 sites
Clinique Medicale du Quartier Latin
Montreal, Quebec
Dr Roger P Leblanc
Montreal, Quebec
Montreal Gen Hosp / Div of Clin Immuno and Allergy
Montreal, Quebec
Toronto Hosp
Toronto, Ontario
Mexico4 sites
Hospital 1 ro de Octubre
Mexico City
Hospital General
Mexico City
Hospital Regional
Mexico City
Instituto Nacional de la Nutricion
Mexico City
Brazil3 sites
Hospital de Clinicas da Universidade Federal do Parana
Curitiba
Hospital Nossa Senhora da Conceicao-GCH
Porto Alegre
Instituto de Infectologia Emilio Ribas
São Paulo
Location not given3 sites
Aurora Hospital
Department of Infection & Tropical Medicine
Klinicka Chorobzkaznych AM
Peru2 sites
Hosp Guillermo Almenara-Medicina 1
Lima
Hosp Nacional Cayetano Heredia
Lima
Puerto Rico2 sites
San Cristobal Hosp
Coto Laurel, Ponce, 00780
Clinical Research Puerto Rico Inc
San Juan, 009091711
United Kingdom2 sites
Whittal Street Clinic
Birmingham
Royal Liverpool Univ Hosp
Liverpool
About this study
Official title: A Randomized Open-label Study of the Antiviral Efficacy and Safety of Atazanavir Versus Lopinavir/Ritonavir(LPV/RTV), Each in Combination With Two Nucleosides in Subjects Who Have Experienced Virologic Failure With Prior Protease Inhibitor-Containing HAART Regimen(s)
This study will compare 2 treatments in the way they affect cholesterol levels and the amount of HIV in the blood.
Read the detailed description
The study is designed to determine the metabolic changes, antiviral activity, safety, and tolerability of atazanavir as compared to LPV/RTV, each in combination with 2 nucleosides, over the initial 24 weeks, with a final analysis at 48 weeks.
- Conditions
- HIV Infections
- Being tested
- Atazanavir, Lopinavir/Ritonavir
- Keywords
- HIV Protease Inhibitors, RNA, Viral, Reverse Transcriptase Inhibitors, Anti-HIV Agents, Viral Load, Lipids, ABT 378, Antiretroviral Therapy, Highly Active, Lipoproteins, LDL Cholesterol
- 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
Lopinavir/RitonavirDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2001 (estimated)
- Study startFeb 2001
- Primary completionSep 2003
- Study completionSep 2003
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
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00028301
- Sponsor's protocol ID
- 302D
- Other IDs
- AI424-043
- Status last verified
- Sep 2010
- First submitted
- 20 Dec 2001
- Last updated
- 13 Sep 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Open-label Study of the Antiviral Efficacy and Safety of Atazanavir Versus Lopinavir/Ritonavir(LPV/RTV), Each in Combination With Two Nucleosides in Subjects Who Have Experienced Virologic Failure With Prior Protease Inhibitor-Containing HAART Regimen(s)
- ClinicalTrials.gov ID
- NCT00028301
- Acronym / sponsor ID
- 302D
- Conditions
- HIV Infections
- Keywords
- HIV Protease Inhibitors, RNA, Viral, Reverse Transcriptase Inhibitors, Anti-HIV Agents, Viral Load, Lipids, ABT 378, Antiretroviral Therapy, Highly Active
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- Feb 2001
- Primary completion
- Sep 2003 (actual)
- Study completion
- Sep 2003 (actual)
- First posted
- 21 Dec 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.
This study will compare 2 treatments in the way they affect cholesterol levels and the amount of HIV in the blood.
Detailed description
The study is designed to determine the metabolic changes, antiviral activity, safety, and tolerability of atazanavir as compared to LPV/RTV, each in combination with 2 nucleosides, over the initial 24 weeks, with a final analysis at 48 weeks.
Study design
- Primary purpose
- Treatment
- Masking
- None (open label)
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- Are receiving a PI-containing highly active antiretroviral therapy (HAART) for at least 12 weeks.
- Have a viral load of 1,000 or more copies/ml within 4 weeks of screening and within 4 weeks prior to randomization.
- Have 2 CD4 cell counts of 50 or more cells/mm3 at least 96 hours apart and within 4 weeks before randomization.
- Are at least 16 years old.
- Have a documented virologic response to at least 1 HAART regimen.
Key exclusion criteria (16 listed)
- Have taken 2 or more PIs and had virologic failure.
- Have taken atazanavir or LPV/RTV.
- Have an HIV-related infection (within 30 days) or any medical condition requiring treatment at the time of enrollment.
- Have had acute hepatitis in the 30 days prior to study entry.
- Have received certain drugs within 3 months of study start or expect to need them at time of enrollment.
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 | – |
| Lopinavir/Ritonavir | 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 13 Sep 2010.
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.
97 sites in 16 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Atazanavir and Lopinavir/Ritonavir in people with HIV Infections, run by Bristol-Myers Squibb at 97 sites in 16 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 10 inclusion and 16 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 13 Sep 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 97 sites in United States, Italy, Spain, Argentina, Belgium and 10 more countries. 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.
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 13 Sep 2010.