HIV-1Phase 3NCT00144833

Open Label Study of 908/RTV in Combination With Other PIs for the Treatment of Multi PI-Experienced HIV Subjects

A Phase 3 study testing fosamprenavir/ritonavir (700mg/100mg BID), fosamprenavir/ritonavir (1400mg/100mg BID) and fosamprenavir/lopinavir/ritonavir (1400mg/533mg/100mg BID) in people with HIV-1, run by GlaxoSmithKline at 42 sites in 9 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

For HIV-infected individuals with highly resistant viruses, higher drug levels may be required to block the virus. This study investigates that concept by comparing the efficacy of standard fosamprenavir/ritonavir to an increased dose of boosted fosamprenavir and to a combination of fosamprenavir (increased… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: HIV-1
What is being tested?: fosamprenavir/ritonavir (700mg/100mg BID), fosamprenavir/ritonavir (1400mg/100mg BID) and fosamprenavir/lopinavir/ritonavir (1400mg/533mg/100mg BID)
How many people: 150 participants
Where: 42 sitesin 9 countries
Study dates: Mar 2005to not given
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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Multiple protease-inhibitors experienced HIV-1 infected individuals experiencing virological failure and who's virus is not fully resistant to boosted fosamprenavir and boosted lopinavir based on genotypic resistance tests.

Who cannot join

No full resistance to FPV/r or LPV/r
Planned use of NNRTIs as part of the study salvage regimen
Application of additional exclusion criteria as determined by physician.

Trial locations and contacts

42 sites in 9 countries.

Country

City, postcode or hospital

42 sites in 9 countries

Canada8 sites

GSK Clinical Trials Call Center
Hamilton, Ontario, L8N 3Z5
GSK Clinical Trials Call Center
Montreal, Quebec, H2L 5B1
GSK Clinical Trials Call Center
Montreal, Quebec, H3G 1A4
GSK Clinical Trials Call Center
Ottawa, Ontario, K1N 6N5
GSK Clinical Trials Call Center
Saint-Foy, Quebec, G1V 4G2
GSK Clinical Trials Call Center
Toronto, Ontario, M4T 3A7
GSK Clinical Trials Call Center
Toronto, Ontario, M5B 1L6
GSK Clinical Trials Call Center
Vancouver, British Columbia, V6Z 2C7

Other trials in Canada

France8 sites

GSK Clinical Trials Call Center
Lagny-sur-Marne, 77400
GSK Clinical Trials Call Center
Paris, 75475
GSK Clinical Trials Call Center
Paris, 75970
GSK Clinical Trials Call Centre
Paris, 93009
GSK Clinical Trials Call Center
Saint-Denis, 93205
GSK Clinical Trials Call Center
Strasbourg, 67000
GSK Clinical Trials Call Center
Toulon, 83000
GSK Clinical Trials Call Center
Vanouvre Les Nancy, 54511

Other trials in France

Italy8 sites

GSK Clinical Trials Call Center
Liguria, 16128
GSK Clinical Trials Call Center
Lombardia, 27100
GSK Clinical Trials Call Center
Romagna, 44100
GSK Clinical Trials Call Center
Rome, 00 168
GSK Clinical Trials Call Centre
Torino, 10149
GSK Clinical Trials Call Center
Toscana, 50126
GSK Clinical Trials Call Center
Toscana, 50139
GSK Clinical Trials Call Center
Veneto, 35128

Other trials in Italy

Spain5 sites

GSK Clinical Trials Call Center
Barcelona, 8025
GSK Clinical Trials Call Center
Jerez de la Frontera, 11407
GSK Clinical Trials Call Center
Madrid, 28029
GSK Clinical Trials Call Center
Madrid, 28040
GSK Clinical Trials Call Center
Madrid, 28041

Other trials in Spain

United Kingdom5 sites

GSK Clinical Trials call Center
Birmingham, B29 JD6
GSK Clinical Trials Call Center
Brighton, BN2 3EW
GSK Clinical Trials Call Center
London, EC1A 7BE
GSK Clinical Trials Call Center
London, NW3 2QG
GSK Clinical Trials Call Center
London, SE5 9RS

Other trials in United Kingdom

Greece4 sites

GSK Clinical Trials Call Center
Athens, 10676
GSK Clinical Trials Call Center
Athens, 11526
GSK Clinical Trials Call Center
Athens, 11527
GSK Clinical Trials Call Center
Piraeus, 18536

Other trials in Greece

Australia2 sites

GSK Clinical Trials Call Center
Carlton, Victoria, 3053
GSK Clinical Trials Call Center
Darlinghurst, New South Wales, 2010

Other trials in Australia

Belgium1 site

GSK Clinical Trials Call Center
Brussels, 1000

Other trials in Belgium

Germany1 site

GSK Clinical Trials Call Center
Hamburg, 20095

Other trials in Germany

About this study

Official title: A Phase III, Randomized, Controlled, Open-Label, Multicentre, Three Arm Study to Compare the Efficacy and Safety of a Dual-Boosted HIV-1 Protease Inhibitor Regimen of Fosamprenavir/Lopinavir/Ritonavir 1400mg/533mg/133mg Twice Daily and an Increased Dosage Regimen of FPV/RTV 1400mg/100mg BID Versus the Standard Dosage Regimen of FPV/RTV 700mg/100mg BID for 24 Weeks in Multiple-PI Experienced, HIV-Infected Adults Experiencing Virological Failure

Conditions: HIV-1
Being tested: fosamprenavir/ritonavir (700mg/100mg BID), fosamprenavir/ritonavir (1400mg/100mg BID), fosamprenavir/lopinavir/ritonavir (1400mg/533mg/100mg BID)
Keywords: Protease inhibitors-experienced HIV-1 infected patients, Highly-resistant HIV-1, Dual boosted Pis, fosamprenavir, lopinavir

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

fosamprenavir/ritonavir (700mg/100mg BID)Drug
fosamprenavir/ritonavir (1400mg/100mg BID)Drug
fosamprenavir/lopinavir/ritonavir (1400mg/533mg/100mg BID)Drug

What is being measured

The primary outcome is the main question the study is designed to answer.

The average area under the curve minus baseline [AAUCMB] in plasma HIV-1 RNA at 24 Weeks when each are administered in combination with an optimised background therapy, in a multiple PI-experienced population experiencing virological failure.
Measured: 24 weeks

Secondary outcomes (1)

Efficacy (AAUCMB) at 48 weeks, safety, tolerability(incidence and nature of AEs and laboratory abnormalities) at week 24 and 48, CD4 change from baseline at week 24 and 48, and the steady-state plasma APV and LPV through concentrations.
Measured: 48 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2005?

First posted5 Sep 2005 (estimated)
Study startMar 2005

Why it stopped: Incomplete data

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for HIV-1Studies of the same condition, open and under way.
More trials run by GlaxoSmithKlineThe 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
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 150 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00144833
Sponsor's protocol ID: APV102002
Status last verified: Nov 2007
First submitted: 1 Sep 2005
Last updated: 12 Nov 2007
Results posted: No
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All HIV-1 trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Nov 2007. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase III, Randomized, Controlled, Open-Label, Multicentre, Three Arm Study to Compare the Efficacy and Safety of a Dual-Boosted HIV-1 Protease Inhibitor Regimen of Fosamprenavir/Lopinavir/Ritonavir 1400mg/533mg/133mg Twice Daily and an Increased Dosage Regimen of FPV/RTV 1400mg/100mg BID Versus the Standard Dosage Regimen of FPV/RTV 700mg/100mg BID for 24 Weeks in Multiple-PI Experienced, HIV-Infected Adults Experiencing Virological Failure
ClinicalTrials.gov ID: NCT00144833
Acronym / sponsor ID: APV102002
Conditions: HIV-1
Keywords: Protease inhibitors-experienced HIV-1 infected patients, Highly-resistant HIV-1, Dual boosted Pis, fosamprenavir, lopinavir
Phase: Phase 3
Study type: Interventional
Recruitment status: TerminatedReason stopped: Incomplete data
Enrolment: 150 participants (estimated)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: Mar 2005
First posted: 5 Sep 2005 (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.

Study design

Primary purpose: Treatment
Allocation: 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 (1 listed)

Multiple protease-inhibitors experienced HIV-1 infected individuals experiencing virological failure and who's virus is not fully resistant to boosted fosamprenavir and boosted lopinavir based on genotypic resistance tests.

Key exclusion criteria (3 listed)

No full resistance to FPV/r or LPV/r
Planned use of NNRTIs as part of the study salvage regimen
Application of additional exclusion criteria as determined by physician.

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
fosamprenavir/ritonavir (700mg/100mg BID)	Drug	–
fosamprenavir/ritonavir (1400mg/100mg BID)	Drug	–
fosamprenavir/lopinavir/ritonavir (1400mg/533mg/100mg BID)	Drug	–

Primary outcome

The average area under the curve minus baseline [AAUCMB] in plasma HIV-1 RNA at 24 Weeks when each are administered in combination with an optimised background therapy, in a multiple PI-experienced population experiencing virological failure.
Time frame: 24 weeks

1 secondary outcome

Efficacy (AAUCMB) at 48 weeks, safety, tolerability(incidence and nature of AEs and laboratory abnormalities) at week 24 and 48, CD4 change from baseline at week 24 and 48, and the steady-state plasma APV and LPV through concentrations.
Time frame: 48 weeks

Results and safety

The study was stopped early (reason given: Incomplete data). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2007.

Related trials for HIV-1

RecruitingPhase 4
A Study to Provide Continued Access to Study Drug to Children and Adolescents Who Have Completed Clinical Studies Involving Gilead HIV Treatments
HIV-1-infection
Not yet recruitingPhase 4
NOTRE: Optimizing Long-Acting Pre-Exposure Prophylaxis and Medications for Opioid Use Disorder Interventions in Carceral Settings
HIV Infections, Opioid Use Disorder
Enrolling by invitation
Effect of Omega-3 Supplementation on Pregnant Outcomes and Inflammation Markers of Women Infected With HIV Using Antiretroviral Therapy
Pregnant HIV Positive Women
Not yet recruiting
Smoking Cessation Program for Lao People With HIV
Smoking Cessation, HIV
Enrolling by invitation
Promoting Aging and Thriving With HIV
HIV (Human Immunodeficiency Virus), Geriatric

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.

GSK Clinical Trials, MD study director

GlaxoSmithKline

42 sites in 9 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 1 inclusion and 3 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 12 Nov 2007. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 42 sites in Canada, France, Italy, Spain, United Kingdom and 4 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 was stopped early (reason given: Incomplete data). 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.

What does the primary outcome measure?

The average area under the curve minus baseline [AAUCMB] in plasma HIV-1 RNA at 24 Weeks when each are administered in combination with an optimised background therapy, in a multiple PI-experienced population experiencing virological failure. (time frame: 24 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00144833.

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 12 Nov 2007; AzTrials last refreshed its copy on 7 Nov 2026.