HIV InfectionsPhase 3NCT00013897
A Comparison of BMS-232632 With Efavirenz, Each in Combination With Zidovudine-Lamivudine
A Phase 3 study testing Atazanavir, Lamivudine/Zidovudine and Efavirenz in people with HIV Infections, run by Bristol-Myers Squibb at 99 sites in 24 countries.
Trial summary
The purpose of this study is to compare the effectiveness of treatment with BMS-232632 to that of efavirenz (EFV) when both are used with zidovudine (ZDV) and lamivudine (3TC). 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, Lamivudine/Zidovudine and Efavirenz
- How many people
- Not given
- Where
- 99 sitesin 24 countries
- Study dates
- Feb 2001to Apr 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:
- Have a viral load of 2,000 or more copies/ml and a CD4 cell count of 100 or more cells/mm3 (or 75 or more cells/mm3 with no prior history of AIDS-defining diagnosis) within 2 weeks before randomization.
- Are at least 16 years old.
- Have signed consent of parent or guardian if under 18 years of age.
- Are willing to use effective barrier methods of birth control.
- Are available for follow-up for at least 52 weeks.
Who cannot join
- Patients will not be eligible for this study if they:
- Have had anti-HIV treatment within 30 days before screening.
- Have a recently diagnosed HIV-related infection.
- Have any medical condition requiring treatment at enrollment.
- Have recently become HIV infected.
- Have acute hepatitis within 30 days of study entry. Certain patients with chronic hepatitis will be eligible.
Show all 14Show fewer
- Expect to need or have taken drugs with myelosuppressive, neurotoxic, pancreatotoxic, hepatotoxic, or cytotoxic potential within 3 months before study. Expect to need methadone, ribavirin/interferons, neurotoxic drugs or drugs that affect CYP3A4.
- Abuse alcohol or drugs.
- Have severe diarrhea within 30 days before study entry.
- Are pregnant or breast-feeding.
- Have a history of hemophilia.
- Have a history of bilateral peripheral neuropathy.
- Cannot take medicines by mouth.
- Have any other conditions that the doctor thinks would interfere with the study.
Trial locations and contacts
99 sites in 24 countries.
99 sites in 24 countries
United States28 sites
Univ of NM
Albuquerque, New Mexico, 87131
Univ of Michigan Hospitals and Health Ctrs
Ann Arbor, Michigan, 481090378
Emory Univ
Atlanta, Georgia, 30308
The CORE Ctr
Chicago, Illinois, 60612
Ohio State Univ Hosp
Columbus, Ohio, 432101282
Oaklawn Physicians Group
Dallas, Texas, 75219
Duke Univ Med Ctr / Infectious Disease Clinic
Durham, North Carolina, 27710
North Broward Hosp District / HIV Clinical Research
Fort Lauderdale, Florida, 33311
Associates in Research
Fort Myers, Florida, 33901
Tarrant County Infectious Diseases Associates
Fort Worth, Texas, 76104
Montrose Clinic
Houston, Texas, 77006
Jemsek Clinic
Huntersville, North Carolina, 28078
Univ of Southern California
Los Angeles, California, 90033
Methodist Healthcare
Memphis, Tennessee, 38104
Steinhart Medical Associates
Miami, Florida, 33133
Robert Wood Johnson Med School/UMDNJ
New Brunswick, New Jersey, 089030019
UMDNJ - New Jersey Med School
Newark, New Jersey, 071032757
Univ of Nebraska Medical Ctr
Omaha, Nebraska, 681985400
Philadelphia FIGHT
Philadelphia, Pennsylvania, 19107
Phoenix Body Positive
Phoenix, Arizona, 85006
Saint Francis Mem Hosp / HIV Care Unit
San Francisco, California, 94109
ID Care Inc
Somerville, New Jersey, 08876
Washington Univ School of Medicine
St Louis, Missouri, 63108
Saint Josephs Comprehensive Research Institute
Tampa, Florida, 33607
Dupont Circle Physicians Group
Washington D.C., District of Columbia, 200091104
Dr Bruce Rashbaum
Washington D.C., District of Columbia, 20037
Julio Arroyo
West Columbia, South Carolina, 29169
Univ of Kansas School of Medicine
Wichita, Kansas, 672143124
Italy8 sites
Ospedale S Orsola
Bologna
Immunoligia Universita Cagliari
Cagliari
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
Hosp 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
France5 sites
Hopital Hotel Dieu de Lyon
Lyon
CHU De Bicetre
Paris
Hopital Cochin - Port Royal
Paris
Services des Maladies Infectieuses
Paris
Hospital Gustave Dron
Tourcoing
Peru5 sites
Hosp Edgardo Rebagliati
Lima
Hosp Guillermo Almenara-Medicina 1
Lima
Hosp Nacional Arzobispo Loayza-PROCETS
Lima
Hosp Nacional Cayetano Heredia
Lima
Hosp Nacional dos de Mayo
Lima
Thailand5 sites
Rajavithi Hosp
Bangkok
Ramathibodi Hosp
Bangkok
Siriraj Hosp / Mahidol Univ
Bangkok
Vajira Hosp
Bangkok
Chiangmai Univ
Chiang Mai
Canada4 sites
Univ of Alberta/Division of Inf Dis/Dept of Med
Edmonton, Alberta
McMaster Univ Med Ctr
Hamilton, Ontario
Gary Rubin
Toronto, Ontario
Univ of British Columbia
Vancouver, British Columbia
Chile4 sites
Fundacion Arriaran
Santiago
Hosp Clinico de La Pontificia Universidad Catolica de Chile
Santiago
Hosp Sotero de Rio
Santiago
Servicio de Dermatologia-Hosp del Salvador
Santiago
South Africa4 sites
Brooklyn Med Ctr
Cape Town
Tygerberg Hosp
Cape Town
Chris Hani Baragwanath Hosp
Johannesburg
Toga Lab
Johannesburg
Russia3 sites
Federal AIDS Ctr
Moscow
Infectious Hosp 30
Saint Petersburg
Ust Izhora Fed Infectious Hosp
Saint Petersburg
United Kingdom3 sites
King's College Hosp
Cambewell
Saint James Hosp
Dublin
Royal Free Hosp
London
Venezuela3 sites
Hosp U de Caracas / Ciudad
Caracas
Hosp Vargas de Caracas
Caracas
Hosp Dr Domingo Luciani
Miranda
Germany2 sites
Rheinische Friedrich Wilhelms Universitaet Medizinische
Bonn
Univ Zu Koeln
Cologne
Guatemala2 sites
Hosp General San Juan de Dios
Guatemala City
Hosp Roosevelt Chief Infectious Diseases Unit
Guatemala City
Malaysia2 sites
Hosp Kuala Lumpur
Kuala Lumpur
Univ of Malaya Med Ctr
Kuala Lumpur
Puerto Rico2 sites
Clinical Research Puerto Rico Inc
San Juan, 009091711
San Juan VAMC
San Juan, 009265800
About this study
Official title: A Phase III Study Comparing the Antiviral Efficacy and Safety of BMS-232632 With Efavirenz; Each in Combination With Fixed Dose Zidovudine-Lamivudine
The purpose of this study is to compare the effectiveness of treatment with BMS-232632 to that of efavirenz (EFV) when both are used with zidovudine (ZDV) and lamivudine (3TC).
Read the detailed description
This is a multinational, 2-arm study. Patients in 1 arm receive BMS-232632 plus EFV placebo capsules. Patients in the other arm receive EFV plus BMS-232632 placebo. Both arms also receive a fixed dose of ZDV-3TC.
- Conditions
- HIV Infections
- Being tested
- Atazanavir, Lamivudine/Zidovudine, Efavirenz
- Keywords
- Placebos, Drug Therapy, Combination, Zidovudine, HIV Protease Inhibitors, Lamivudine, RNA, Viral, Reverse Transcriptase Inhibitors, Anti-HIV Agents, Viral Load, BMS 232632, efavirenz
- 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
Lamivudine/ZidovudineDrug
EfavirenzDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2001 (estimated)
- Study startFeb 2001
- Primary completionApr 2003
- Study completionApr 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
- Double blind
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00013897
- Sponsor's protocol ID
- 302C
- Other IDs
- AI424-034
- Status last verified
- Apr 2011
- First submitted
- 31 Mar 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 BMS-232632 With Efavirenz; Each in Combination With Fixed Dose Zidovudine-Lamivudine
- ClinicalTrials.gov ID
- NCT00013897
- Acronym / sponsor ID
- 302C
- Conditions
- HIV Infections
- Keywords
- Placebos, Drug Therapy, Combination, Zidovudine, HIV Protease Inhibitors, Lamivudine, RNA, Viral, Reverse Transcriptase Inhibitors, Anti-HIV Agents
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- Feb 2001
- Primary completion
- Apr 2003 (actual)
- Study completion
- Apr 2003 (actual)
- First posted
- 31 Aug 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 effectiveness of treatment with BMS-232632 to that of efavirenz (EFV) when both are used with zidovudine (ZDV) and lamivudine (3TC).
Detailed description
This is a multinational, 2-arm study. Patients in 1 arm receive BMS-232632 plus EFV placebo capsules. Patients in the other arm receive EFV plus BMS-232632 placebo. Both arms also receive a fixed dose of ZDV-3TC.
Study design
- Primary purpose
- Treatment
- Masking
- Double blind
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Have a viral load of 2,000 or more copies/ml and a CD4 cell count of 100 or more cells/mm3 (or 75 or more cells/mm3 with no prior history of AIDS-defining diagnosis) within 2 weeks before randomization.
- Are at least 16 years old.
- Have signed consent of parent or guardian if under 18 years of age.
- Are willing to use effective barrier methods of birth control.
- Are available for follow-up for at least 52 weeks.
Key exclusion criteria (14 listed)
- Have had anti-HIV treatment within 30 days before screening.
- Have a recently diagnosed HIV-related infection.
- Have any medical condition requiring treatment at enrollment.
- Have recently become HIV infected.
- Have acute hepatitis within 30 days of study entry. Certain patients with chronic hepatitis will be eligible.
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 | – |
| Lamivudine/Zidovudine | Drug | – |
| Efavirenz | 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 4 May 2011.
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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.
The record lists no contact. Use the official record to reach the sponsor.
99 sites in 24 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Atazanavir, Lamivudine/Zidovudine and Efavirenz in people with HIV Infections, run by Bristol-Myers Squibb at 99 sites in 24 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 6 inclusion and 14 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 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 99 sites in United States, Italy, Spain, France, Peru and 19 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 4 May 2011.