HIV InfectionsPhase 2NCT00038532
Amprenavir/Ritonavir, Saquinavir/Ritonavir or Efavirenz in HIV-Infected Subjects Following Failure With Kaletra (ABT-378/Ritonavir) as Their First Protease Inhibitor Based HAART
A Phase 2 study testing Amprenavir/ritonavir, Saquinavir/ritonavir and Efavirenz in people with HIV Infections, run by Abbott at 54 sites in 11 countries.
Trial summary
The purpose of this study is to study amprenavir/ritonavir, saquinavir/ritonavir or efavirenz in HIV-infected patients following failure with Kaletra (ABT-378/ritonavir) as their first protease inhibitor based HAART. 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?
- Amprenavir/ritonavir, Saquinavir/ritonavir and Efavirenz
- How many people
- 24 participants
- Where
- 54 sitesin 11 countries
- Study dates
- Apr 2001to not given
- Phase
- Phase 2
- 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
- Remain on present anti-HIV drugs during screening until a new regimen is started.
- Have a viral load of at least 1,000 copies/ml on the 2 most recent tests after at least 24 weeks of lopinavir/ritonavir and while still on it.
- Have an HIV which shows reduced susceptibility to lopinavir.
- Are at least 18 years old.
- Are not presently ill.
- Have not been treated for an opportunistic infection within 30 days of screening.
- Agree not to take certain drugs and agree to inform and get permission from the doctor before taking any medicines, over the counter medicines, herbal medicines, alcohol or recreational drugs.
- Agree to use an accepted barrier method of birth control.
Who cannot join
- Female subject is pregnant or lactating.
- Have taken any protease inhibitor other than lopinavir/ritonavir for more that two weeks.
- Are taking chemotherapy.
- Have a medical problem with their pancreas.
- Have been screened for this study within the past 12 weeks.
- Appear to be unsuitable in the opinion of the doctor.
Trial locations and contacts
54 sites in 11 countries.
54 sites in 11 countries
United States26 sites
IDC Research Initiative
Altamonte Springs, Florida, 32701
AIDS Research Consortium of Atlanta, Inc.
Atlanta, Georgia, 30308
David Wright, M.D.
Austin, Texas, 78705
CORE Center
Chicago, Illinois, 60612
University of Cincinnati Medical Center
Cincinnati, Ohio, 45267-0405
20th Avenue Medical Center Kaiser Permanente
Denver, Colorado, 80205
University of Colorado Health Sciences Center
Denver, Colorado, 80262
Gary J. Richmond, M.D.
Fort Lauderdale, Florida, 33316
Associates in Research
Fort Myers, Florida, 33901
Paul J. Cimoch, M.D.
Fountain Valley, California, 92780
University of Texas Medical Branch
Galveston, Texas, 77555-0435
Hampton Roads Medical Specialists
Hampton, Virginia, 23666
Diversified Medical Practices, P.A.
Houston, Texas, 77027
AIDS Health Care Foundation - Research Center
Los Angeles, California, 90027
Tower Infectious Diseases Medical Associates
Los Angeles, California, 90048
University of Miami School of Medicine
Miami, Florida, 33136
Howard A. Grossman, M.D.
New York, New York, 10011
John B. Montana, M.D.
New York, New York, 10011
Saint Michael's Medical Center
Newark, New Jersey, 07102
Phoenix Body Positive, Inc.
Phoenix, Arizona, 85006
The Research & Education Group
Portland, Oregon, 97209
Bornemann Internal Medicine
Reading, Pennsylvania, 19601
David Parks, M.D.
St Louis, Missouri, 63139
State University of New York at Stony Brook
Stony Brook, New York, 11794-08153
Infectious Disease Research Institute, Inc.
Tampa, Florida, 33614
Donna E. Sweet, M.D.
Wichita, Kansas, 67214
France6 sites
Hopital Michalon - C.H.U. de Grenoble
Grenoble, 38043
Groupe Hospitalier Cochin -Saint-Vincent-de-Paul La Roche-Guyon
Paris, 75679
Hopital Tenon
Paris, 75970
Hospital Yves Le Foll
Saint-Brieuc, 22023
La Seyne sur Mer, Hopital Chalucet
Toulon, 83056
C.H.U. Brabois - Tour Drouet, Rue du Morvan
Vandœuvre-lès-Nancy, 54511
Spain6 sites
Hospital Germans Trias I Pujol
Badalona, 08916
Hospital De La Sta Creu I San Pau
Barcelona, 08025
Hospital Clinic I Provincial
Barcelona, 08036
Hospital Carlos III
Madrid, 28010
Hospital La Paz
Madrid, 28046
Hospital Universitario Vergen del Rocio
Seville, 41013
Germany5 sites
CORE Center
Berlin, 13353
Universitatsklinikum
Düsseldorf, 40225
Klinikum J.W. Goethe Universitat
Frankfurt, 60596
Institut fur Immunologie Pathologie und Molekularbiologie
Hamburg, 20099
Albrecht Ulmer, M.D.
Stuttgart, 70197
Canada3 sites
Montreal Chest Institute/Royal Victoria Hospital
Montreal, Quebec, H2X 2PA
Ottawa Hospital General Campus
Ottawa, Ontario, K1H 8L6
Toronto General Hospital Division of The University Health Network
Toronto, Ontario, M5G-2C4
Argentina2 sites
Hospital Muniz - FUNDAI
Buenos Aires, 4304-2180
Fundacion Huesped
Buenos Aires, 4981-1855
Puerto Rico2 sites
Centro Familiar, Inc
Ponce, 00731
New Puerto Rico CONCRA
Rio Piedras, 00925
About this study
Official title: An Open Label, Phase II Study of Amprenavir/Ritonavir, Saquinavir/Ritonavir or Efavirenz in HIV-Infected Subjects Following Failure With Kaletra (ABT-378/Ritonavir) as Their First Protease Inhibitor Based HAART
The purpose of this study is to study amprenavir/ritonavir, saquinavir/ritonavir or efavirenz in HIV-infected patients following failure with Kaletra (ABT-378/ritonavir) as their first protease inhibitor based HAART.
- Conditions
- HIV Infections
- Being tested
- Amprenavir/ritonavir, Saquinavir/ritonavir, Efavirenz
- Keywords
- treatment experienced, HIV
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amprenavir/ritonavirDrug
Saquinavir/ritonavirDrug
EfavirenzDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects with plasma HIV RNA levels below the limit of quantification (400 copies/mL) at week 24 and the time until loss of virologic response through week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2002 (estimated)
- Study startApr 2001
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.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants
Sponsor and investigators
- Lead sponsor
- Abbott
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Eugene Sun, M.D., Study chair, Divisional Vice President, Infectious Diseases and Virology Development
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00038532
- Sponsor's protocol ID
- M01-287
- Status last verified
- Jul 2006
- First submitted
- 31 May 2002
- Last updated
- 1 Apr 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Phase II Study of Amprenavir/Ritonavir, Saquinavir/Ritonavir or Efavirenz in HIV-Infected Subjects Following Failure With Kaletra (ABT-378/Ritonavir) as Their First Protease Inhibitor Based HAART
- ClinicalTrials.gov ID
- NCT00038532
- Acronym / sponsor ID
- M01-287
- Conditions
- HIV Infections
- Keywords
- treatment experienced, HIV
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants
- Lead sponsor
- AbbottIndustry (pharma, biotech, devices)
- Study start
- Apr 2001
- First posted
- 3 Jun 2002 (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 study amprenavir/ritonavir, saquinavir/ritonavir or efavirenz in HIV-infected patients following failure with Kaletra (ABT-378/ritonavir) as their first protease inhibitor based HAART.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Remain on present anti-HIV drugs during screening until a new regimen is started.
- Have a viral load of at least 1,000 copies/ml on the 2 most recent tests after at least 24 weeks of lopinavir/ritonavir and while still on it.
- Have an HIV which shows reduced susceptibility to lopinavir.
- Are at least 18 years old.
- Are not presently ill.
Key exclusion criteria (6 listed)
- Female subject is pregnant or lactating.
- Have taken any protease inhibitor other than lopinavir/ritonavir for more that two weeks.
- Are taking chemotherapy.
- Have a medical problem with their pancreas.
- Have been screened for this study within the past 12 weeks.
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 |
|---|---|---|
| Amprenavir/ritonavir | Drug | – |
| Saquinavir/ritonavir | Drug | – |
| Efavirenz | Drug | – |
Primary outcome
Proportion of subjects with plasma HIV RNA levels below the limit of quantification (400 copies/mL) at week 24 and the time until loss of virologic response through week 48
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 1 Apr 2008.
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.
Eugene Sun, M.D. study chair
Divisional Vice President, Infectious Diseases and Virology Development
54 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Amprenavir/ritonavir, Saquinavir/ritonavir and Efavirenz in people with HIV Infections, run by Abbott at 54 sites in 11 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 8 inclusion and 6 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 1 Apr 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 54 sites in United States, France, Spain, Germany, Canada and 6 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Proportion of subjects with plasma HIV RNA levels below the limit of quantification (400 copies/mL) at week 24 and the time until loss of virologic response through week 48. 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 1 Apr 2008.