HIV InfectionsPhase 3NCT00028067
A Comparison of Atazanavir and Nelfinavir, Each in Combination With 2 NRTIs, in Patients Who Have Failed Treatments Without a Protease Inhibitor
A Phase 3 study testing Atazanavir and Nelfinavir mesylate in people with HIV Infections, run by Bristol-Myers Squibb at 62 sites in 5 countries.
Trial summary
The purpose of this study is to compare the atazanavir and nelfinavir (NFV) treatments in their ability to reduce viral load. 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 Nelfinavir mesylate
- How many people
- 500 participants
- Where
- 62 sitesin 5 countries
- Study dates
- Aug 2001to Apr 2002
- 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:
- Have a viral load of 1000 or more copies/ml within 3 weeks before randomization. Have a CD4 cell count of 50 or more cells/mm3 within 3 weeks prior to randomization.
- Are at least 16 years old (or the minimum age by local requirements).
- Have had more than 16 weeks of therapy with a non-nucleoside reverse transcriptase inhibitor (NNRTI) and/or nucleoside reverse transcriptase inhibitor (NRTI).
- Use effective barrier method of contraception.
- Give written informed consent.
- Are available for follow-up for at least 52 weeks.
Who cannot join
- Patients may not be eligible for this study if they:
- Have used a protease inhibitor (PI) treatment for more than 7 days or within 30 days prior to screening.
- Have a newly-diagnosed HIV-related infection or any medical condition requiring relatively short but intense therapy at the time of enrollment.
- Have hepatitis in the 30 days before the study. Patients with long-term hepatitis are eligible if their liver function meets certain requirements.
- Are unable to demonstrate responsiveness to a provided NRTI.
- Have had previous or expect a need for therapy with agents that may cause damage to nerve tissue, the pancreas, the liver, bone marrow, or cells within 3 months of study start.
Show all 15Show fewer
- Use too much alcohol or drugs to be able to follow the study therapy; or if they use enough to increase the risk of developing pancreatitis or chemical hepatitis.
- Have severe diarrhea within 30 days prior to study entry.
- Are pregnant or breast-feeding.
- Have a history of hemophilia.
- Have history or signs of bilateral peripheral neuropathy.
- Have cardiomyopathy.
- Have certain heart problems.
- Cannot tolerate oral medication.
- Have any other problems that would interfere with the study.
Trial locations and contacts
62 sites in 5 countries.
62 sites in 5 countries
United States47 sites
Summa Health System
Akron, Ohio, 44304
IDC Research Initiative
Altamonte Springs, Florida, 32701
Philip Brachman
Atlanta, Georgia, 30309
Larry Bush
Atlantis, Florida, 33462
Med College of Georgia
Augusta, Georgia, 30912
East Bay AIDS Ctr
Berkeley, California, 94705
Beth Israel Deaconess Med Ctr
Boston, Massachusetts, 02215
Bach and Godofsky
Bradenton, Florida, 34205
Community Research Initiative of New England
Brookline, Massachusetts, 02445
Ludwig Lettau Private Practice
Charleston, South Carolina, 29414
Carolinas Med Ctr
Charlotte, North Carolina, 28232
Cook County Gen Hosp / Division of Infect Diseases
Chicago, Illinois, 60612
Univ of South Carolina School of Medicine
Columbia, South Carolina, 29203
North Texas Center for AIDS & Clinical Research
Dallas, Texas, 75208
Univ of Texas Southwestern Med Ctr
Dallas, Texas, 75390
Henry Ford Hosp
Detroit, Michigan, 48202
North Broward Hosp District / HIV Clinical Research
Fort Lauderdale, Florida, 33311
Gary Richmond MD
Fort Lauderdale, Florida, 33316
Orange County Ctr for Special Immunology
Fountain Valley, California, 92708
Hampton Roads Med Specialists
Hampton, Virginia, 23666
Piedmont Infectious Disease Consultants
Hickory, North Carolina, 28602
Joseph Gathe
Houston, Texas, 77004
Univ TX Health Science Ctr
Houston, Texas, 77030
Jemsek Clinic
Huntersville, North Carolina, 28078
Division of Inf Diseases/ Indiana Univ Hosp
Indianapolis, Indiana, 46202
Health for Life Clinic
Little Rock, Arkansas, 72205
Tower Infectious Diseases
Los Angeles, California, 90048
Wisconsin AIDS Research Consortium
Milwaukee, Wisconsin, 53203
Tulane Univ School of Medicine
New Orleans, Louisiana, 70112
Community Research Initiative on AIDS
New York, New York, 10018
Saint Luke's - Roosevelt Hosp Ctr
New York, New York, 10019
Mount Sinai Med Ctr
New York, New York, 10029
Hahnemann Univ Hosp
Philadelphia, Pennsylvania, 19102
Research & Education Group
Portland, Oregon, 97209
Kaiser Hospital
Sacramento, California, 95825
HIV Institute / Davies Med Ctr
San Francisco, California, 94114
Kaiser Foundation Hospital
San Francisco, California, 94118
Infectious Diseases Associates
Sarasota, Florida, 34239
South Jersey Infectious Diseases Inc
Somers Point, New Jersey, 08244
CRI - Springfield
Springfield, Massachusetts, 01107
Washington Univ School of Medicine
St Louis, Missouri, 63108
Daniel Seekins
Tampa, Florida, 33607
Infectious Disease Research Inst
Tampa, Florida, 33614
Albert Einstein College of Medicine
The Bronx, New York, 10461
Associates in Med and Mental Health
Tulsa, Oklahoma, 74114
Infectious Disease Clinic
Warren, Michigan, 48089
Wake Forest Univ School of Medicine
Winston-Salem, North Carolina, 27157
Canada5 sites
McMaster Univ Med Ctr
Hamilton, Ontario
Clinique Medicale du Quartier Latin
Montreal, Quebec
Clinique Medicale L'Actuele
Montreal, Quebec
Sunnybrook Health Science Ctr
Toronto, Ontario
Downtown Infectious Diseases Clinic
Vancouver, British Columbia
Mexico4 sites
Hospital General De Mexico
Mexico City
Hospital Regional
Mexico City
Instituto Nacional de Enfermedades Respiratorias
Mexico City
Instituto Nacional de la Nutricion
Mexico City
Thailand4 sites
Program on AIDS / Thai Red Cross Society
Bangkok
Ramathibodi Hosp
Bangkok
Siriraj Hosp / Mahidol Univ
Bangkok
Khonkaen Univ
Khonkaen
Puerto Rico2 sites
Ponce School of Medicine
Ponce, 00732
Hepatology / Infectious Diseases
Santruce, 00909
About this study
Official title: A Phase III Study Comparing the Antiviral Efficacy and Safety of Atazanavir With Nelfinavir: Each in Combination With Dual Nucleoside Therapy in HIV-Infected Subjects Who Have Failed a Regimen Not Containing a Protease Inhibitor
The purpose of this study is to compare the atazanavir and nelfinavir (NFV) treatments in their ability to reduce viral load.
Read the detailed description
In this double-blind, double-placebo, randomized, 2-arm study, atazanavir and NFV each are given in combination with 2 open-label nucleoside reverse transcriptase inhibitors (NRTIs) over 48 weeks. Patients assigned to atazanavir will receive placebo capsules which are identical in size and appearance to NFV. Patients assigned to NFV will receive placebo capsules which are identical in size and appearance to atazanavir. HIV levels are monitored.
- Conditions
- HIV Infections
- Being tested
- Atazanavir, Nelfinavir mesylate
- Keywords
- Drug Therapy, Combination, HIV Protease Inhibitors, RNA, Viral, Reverse Transcriptase Inhibitors, Viral Load, BMS 232632
- 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
Nelfinavir mesylateDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2001 (estimated)
- Study startAug 2001
- Primary completionApr 2002
- Study completionApr 2002
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
- Enrolment
- 500 participants
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Michael Giordano, Study director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00028067
- Sponsor's protocol ID
- 302F
- Other IDs
- AI424-037
- Status last verified
- Apr 2011
- First submitted
- 10 Dec 2001
- Last updated
- 4 May 2011
- Results posted
- No
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
- A Phase III Study Comparing the Antiviral Efficacy and Safety of Atazanavir With Nelfinavir: Each in Combination With Dual Nucleoside Therapy in HIV-Infected Subjects Who Have Failed a Regimen Not Containing a Protease Inhibitor
- ClinicalTrials.gov ID
- NCT00028067
- Acronym / sponsor ID
- 302F
- Conditions
- HIV Infections
- Keywords
- Drug Therapy, Combination, HIV Protease Inhibitors, RNA, Viral, Reverse Transcriptase Inhibitors, Viral Load, BMS 232632
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 500 participants
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- Aug 2001
- Primary completion
- Apr 2002 (actual)
- Study completion
- Apr 2002 (actual)
- First posted
- 11 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.
The purpose of this study is to compare the atazanavir and nelfinavir (NFV) treatments in their ability to reduce viral load.
Detailed description
In this double-blind, double-placebo, randomized, 2-arm study, atazanavir and NFV each are given in combination with 2 open-label nucleoside reverse transcriptase inhibitors (NRTIs) over 48 weeks. Patients assigned to atazanavir will receive placebo capsules which are identical in size and appearance to NFV. Patients assigned to NFV will receive placebo capsules which are identical in size and appearance to atazanavir. HIV levels are monitored.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Have a viral load of 1000 or more copies/ml within 3 weeks before randomization. Have a CD4 cell count of 50 or more cells/mm3 within 3 weeks prior to randomization.
- Are at least 16 years old (or the minimum age by local requirements).
- Have had more than 16 weeks of therapy with a non-nucleoside reverse transcriptase inhibitor (NNRTI) and/or nucleoside reverse transcriptase inhibitor (NRTI).
- Use effective barrier method of contraception.
- Give written informed consent.
Key exclusion criteria (15 listed)
- Have used a protease inhibitor (PI) treatment for more than 7 days or within 30 days prior to screening.
- Have a newly-diagnosed HIV-related infection or any medical condition requiring relatively short but intense therapy at the time of enrollment.
- Have hepatitis in the 30 days before the study. Patients with long-term hepatitis are eligible if their liver function meets certain requirements.
- Are unable to demonstrate responsiveness to a provided NRTI.
- Have had previous or expect a need for therapy with agents that may cause damage to nerve tissue, the pancreas, the liver, bone marrow, or cells within 3 months of study start.
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 | – |
| Nelfinavir mesylate | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2011.
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.
Michael Giordano study director
62 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Atazanavir and Nelfinavir mesylate in people with HIV Infections, run by Bristol-Myers Squibb at 62 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 7 inclusion and 15 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 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 62 sites in United States, Canada, Mexico, Thailand, 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 was stopped early. 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.
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 4 May 2011.