HIV InfectionsPhase 2/3NCT00038519
Amprenavir/Ritonavir or Saquinavir/Ritonavir in HIV-Infected Subjects Following Failure With Kaletra as Their Second Protease Inhibitor
A Phase 2/3 study testing Amprenavir/ritonavir and Saquinavir/ritonavir in people with HIV Infections, run by Abbott at 52 sites in 10 countries.
Trial summary
The purpose of this study is to study the safety and efficacy of Amprenavir/ritonavir or saquinavir/ritonavir in HIV infected patients that have failed Kaletra as their second 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 and Saquinavir/ritonavir
- How many people
- 16 participants
- Where
- 52 sitesin 10 countries
- Study dates
- Apr 2001to not given
- Phase
- Phase 2/3
- 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
- Subject must remain on current antiretroviral therapy during screening until a new regimen is initiated.
- Subject demonstrates reduced susceptibility to lopinavir.
- Subject's two most recent viral loads obtained after at least 16 weeks of lopinavir/ritonavir therapy, and while still on Kaletra therapy must be at least 1,000 copies/mL.
- The Kaletra regimen must be the subject's second PI containing regimen and must not contain any other PIs.
- Subject is at least 18 years of age.
- Subject has not been treated for an active opportunistic infection within 30 days of screening.
Who cannot join
- Subject has a history of active substance abuse or psychiatric illness that could preclude compliance to the protocol.
- Female subject pregnant or lactating.
- Use of an Investigational drug within 30 days prior to the initiation of drug dosing.
- Subject is receiving systemic chemotherapy.
- Subject has a history of acute or chronic pancreatitis.
Trial locations and contacts
52 sites in 10 countries.
52 sites in 10 countries
United States23 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
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
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
Service du C.I.S.I.H. - C.H.U. de Grenoble
La Tronche, 38700
Hospital Tenon
Paris, 75020
Groupe Hospitalier Cochin -Saint-Vincent-de-Paul La Roche-Guyon
Paris, 75679
Hospital Yves Le Foll
Saint-Brieuc, 22023
La Seyne sur Mer, Hopital Chalucet
Toulon, 83056
Tour Drouet - C.H.U. Brabois
Vandœuvre-lès-Nancy, Cedex, 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
Canada4 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
Phillip Sestak, M.D
Vancouver, British Columbia, V6Z 3T1
Italy4 sites
S. Raffaele Hospital
Milan, 20127
III Infectious Diseases Division IRCCS "L. Spallanzani"
Rome, 00149
IRCCS "L. Spallanzani"
Rome, 00149
Hospital "Amedeo di Savoia"
Torino, 10149
Brazil3 sites
Hospital Evandro Chagas - Fiocryz
Rio de Janeiro, 21045-900
Hospital do Servidor Publico Estadual de Sao Paulo
São Paulo, São Paulo, 04029-000
Hospital Heliopolis
São Paulo, 01332-000
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 or Saquinavir/Ritonavir in HIV-Infected Subjects Following Failure With Kaletra (Lopinavir/Ritonavir) as Their Second Protease Inhibitor.
The purpose of this study is to study the safety and efficacy of Amprenavir/ritonavir or saquinavir/ritonavir in HIV infected patients that have failed Kaletra as their second protease inhibitor based HAART.
- Conditions
- HIV Infections
- Being tested
- Amprenavir/ritonavir, Saquinavir/ritonavir
- 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
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 2/3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16 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
- NCT00038519
- Sponsor's protocol ID
- M00-261
- Status last verified
- Jul 2006
- First submitted
- 31 May 2002
- Last updated
- 28 Jul 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Phase II Study of Amprenavir/Ritonavir or Saquinavir/Ritonavir in HIV-Infected Subjects Following Failure With Kaletra (Lopinavir/Ritonavir) as Their Second Protease Inhibitor.
- ClinicalTrials.gov ID
- NCT00038519
- Acronym / sponsor ID
- M00-261
- Conditions
- HIV Infections
- Keywords
- treatment experienced, HIV
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 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 the safety and efficacy of Amprenavir/ritonavir or saquinavir/ritonavir in HIV infected patients that have failed Kaletra as their second 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 (6 listed)
- Subject must remain on current antiretroviral therapy during screening until a new regimen is initiated.
- Subject demonstrates reduced susceptibility to lopinavir.
- Subject's two most recent viral loads obtained after at least 16 weeks of lopinavir/ritonavir therapy, and while still on Kaletra therapy must be at least 1,000 copies/mL.
- The Kaletra regimen must be the subject's second PI containing regimen and must not contain any other PIs.
- Subject is at least 18 years of age.
Key exclusion criteria (5 listed)
- Subject has a history of active substance abuse or psychiatric illness that could preclude compliance to the protocol.
- Female subject pregnant or lactating.
- Use of an Investigational drug within 30 days prior to the initiation of drug dosing.
- Subject is receiving systemic chemotherapy.
- Subject has a history of acute or chronic pancreatitis.
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 | – |
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 28 Jul 2006.
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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.
Eugene Sun, M.D. study chair
Divisional Vice President, Infectious Diseases and Virology Development
52 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Amprenavir/ritonavir and Saquinavir/ritonavir in people with HIV Infections, run by Abbott at 52 sites in 10 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 5 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 28 Jul 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 52 sites in United States, France, Spain, Canada, Italy and 5 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 combined 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.
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?
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 28 Jul 2006.