HIV InfectionPhase 3NCT00085943

KALETRA Or LEXIVA With Ritonavir Combined With EPIVIR And Abacavir In Naive Subjects Over 48 Weeks

A Phase 3 study testing LEXIVA (GW433908), Ritonavir and KALETRA in people with HIV Infection and Infection, Human Immunodeficiency Virus, run by GlaxoSmithKline at 119 sites in 14 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

This study will compare the ability of fosamprenavir 700 mg with ritonavir 100 mg twice a day or lopinavir 400 mg with ritonavir 100 mg twice a day both combined with a fixed dose combination tablet of abacavir 600 mg and lamivudine 300 mg once a day to suppress virus levels of HIV to less than 400 copies/mL of blood. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: HIV Infection, Infection, Human Immunodeficiency Virus
What is being tested?: LEXIVA (GW433908), Ritonavir and KALETRA
How many people: 866 participants
Where: 119 sitesin 14 countries
Study dates: May 2004to 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
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

HIV infected subjects that are naive to anti-HIV therapy.
History of a positive HIV test.
At least 1000 copies/mL of HIV in their blood as screening.

Who cannot join

Active HIV-related diseases.
Taking other investigational drugs.
Pregnant or breastfeeding females.
Not be suitable to participate per investigator opinion.

Trial locations and contacts

119 sites in 14 countries.

Country

City, postcode or hospital

119 sites in 14 countries

United States60 sites

GSK Investigational Site
Atlanta, Georgia, 30308
GSK Investigational Site
Atlanta, Georgia, 30339
GSK Investigational Site
Baltimore, Maryland, 21201
GSK Investigational Site
Birmingham, Alabama, 35233
GSK Investigational Site
Boston, Massachusetts, 02115
GSK Investigational Site
Boston, Massachusetts, 02118
GSK Investigational Site
Bradenton, Florida, 34205
GSK Investigational Site
Chapel Hill, North Carolina, 27516
GSK Investigational Site
Charlotte, North Carolina, 28209
GSK Investigational Site
Charlottesville, Virginia, 22908
GSK Investigational Site
Chicago, Illinois, 60612-7230
GSK Investigational Site
Chicago, Illinois, 60612
GSK Investigational Site
Chicago, Illinois, 60613
GSK Investigational Site
Chicago, Illinois, 60657
GSK Investigational Site
Columbia, South Carolina, 29206-4713
GSK Investigational Site
Dallas, Texas, 75208
GSK Investigational Site
Dallas, Texas, 75246
GSK Investigational Site
Denver, Colorado, 80220
GSK Investigational Site
Durham, North Carolina, 27710
GSK Investigational Site
Fort Lauderdale, Florida, 33308
GSK Investigational Site
Fort Worth, Texas, 76104
GSK Investigational Site
Greenville, North Carolina, 27858
GSK Investigational Site
Hampton, Virginia, 23666
GSK Investigational Site
Hillsborough, New Jersey, 08876
GSK Investigational Site
Houston, Texas, 77004
GSK Investigational Site
Houston, Texas, 77030
GSK Investigational Site
Indianapolis, Indiana, 46202
GSK Investigational Site
Indianapolis, Indiana, 46280
GSK Investigational Site
Jackson, Mississippi, 39202
GSK Investigational Site
Knoxville, Tennessee, 37920
GSK Investigational Site
Lexington, Kentucky, 40536
GSK Investigational Site
Los Angeles, California, 90046
GSK Investigational Site
Lynchburg, Virginia, 24501
GSK Investigational Site
Miami, Florida, 33136
GSK Investigational Site
New York, New York, 10014
GSK Investigational Site
Newark, New Jersey, 07103
GSK Investigational Site
Orlando, Florida, 32804
GSK Investigational Site
Pembroke Pines, Florida, 33024
GSK Investigational Site
Philadelphia, Pennsylvania, 19102
GSK Investigational Site
Philadelphia, Pennsylvania, 19107
GSK Investigational Site
Phoenix, Arizona, 85006
GSK Investigational Site
Providence, Rhode Island, 02906
GSK Investigational Site
Rochester, New York, 14620
GSK Investigational Site
Sacramento, California, 95825
GSK Investigational Site
San Francisco, California, 94115-1931
GSK Investigational Site
Seattle, Washington, 98101
GSK Investigational Site
Seattle, Washington, 98104
GSK Investigational Site
Somers Point, New Jersey, 08244
GSK Investigational Site
Spokane, Washington, 99204
GSK Investigational Site
Stony Brook, New York, 11794-8091
GSK Investigational Site
Tampa, Florida, 33602
GSK Investigational Site
Tampa, Florida, 33607
GSK Investigational Site
Tampa, Florida, 33614
GSK Investigational Site
The Bronx, New York, 10461
GSK Investigational Site
The Bronx, New York, 10468
GSK Investigational Site
Toledo, Ohio, 43614-5809
GSK Investigational Site
Voorhees Township, New Jersey, 08043
GSK Investigational Site
Washington D.C., District of Columbia, 20007
GSK Investigational Site
Washington D.C., District of Columbia, 20036
GSK Investigational Site
Washington D.C., District of Columbia, 20037

Other trials in United States

Spain11 sites

GSK Investigational Site
Barcelona, 08003
GSK Investigational Site
Elche (Alicante), 03202
GSK Investigational Site
Madrid, 28034
GSK Investigational Site
Madrid, 28040
GSK Investigational Site
Madrid, 28047
GSK Investigational Site
Málaga, 29010
GSK Investigational Site
Palma de Mallorca, 07014
GSK Investigational Site
Seville, 41013
GSK Investigational Site
Tarrasa, Barcelona, 08221
GSK Investigational Site
Valencia, 46010
GSK Investigational Site
Vigo ( Pontevedra), 36204

Other trials in Spain

France9 sites

GSK Investigational Site
Bordeaux, 33076
GSK Investigational Site
Le Kremlin-Bicêtre, 94275
GSK Investigational Site
Lyon, 69288
GSK Investigational Site
Lyon, 69437
GSK Investigational Site
Paris, 75018
GSK Investigational Site
Paris, 75475
GSK Investigational Site
Paris, 75651
GSK Investigational Site
Paris, 75679
GSK Investigational Site
Saint-Denis, 93205

Other trials in France

Canada8 sites

GSK Investigational Site
Calgary, Alberta, T2P 1H9
GSK Investigational Site
Montreal, Quebec, H2L 4P9
GSK Investigational Site
Montreal, Quebec, H2L 5B1
GSK Investigational Site
Ottawa, Ontario, K1N 6N5
GSK Investigational Site
Toronto, Ontario, M4N 3M5
GSK Investigational Site
Toronto, Ontario, M4T 3A7
GSK Investigational Site
Toronto, Ontario, M5B 1W8
GSK Investigational Site
Toronto, Ontario, M5G 2C4

Other trials in Canada

Germany7 sites

GSK Investigational Site
Berlin, State of Berlin, 13353
GSK Investigational Site
Frankfurt am Main, Hesse, 60590
GSK Investigational Site
Fürth, Bavaria, 90762
GSK Investigational Site
Hamburg, Free and Hanseatic City of Hamburg, 20099
GSK Investigational Site
Hamburg, Free and Hanseatic City of Hamburg, 20146
GSK Investigational Site
Hanover, Lower Saxony, 30159
GSK Investigational Site
Munich, Bavaria, 80331

Other trials in Germany

Italy7 sites

GSK Investigational Site
Busto Arsizio (VA), Lombardy, 21052
GSK Investigational Site
Ferrara, Emilia-Romagna, 44100
GSK Investigational Site
Milan, Lombardy, 20127
GSK Investigational Site
Milan, Lombardy, 20157
GSK Investigational Site
Modena, Emilia-Romagna, 41100
GSK Investigational Site
Rimini, Emilia-Romagna, 47900
GSK Investigational Site
Turin, Piedmont, 10149

Other trials in Italy

Belgium5 sites

GSK Investigational Site
Brussels, 1000
GSK Investigational Site
Charleroi, 6000
GSK Investigational Site
Ghent, 9000
GSK Investigational Site
Leuven, 3000
GSK Investigational Site
Liège, 4000

Other trials in Belgium

Poland3 sites

GSK Investigational Site
Bydgoszcz, 85-030
GSK Investigational Site
Szczecin, 71-455
GSK Investigational Site
Wroclaw, 51-149

Other trials in Poland

Switzerland3 sites

GSK Investigational Site
Lugano, 6900
GSK Investigational Site
Olten, 4600
GSK Investigational Site
Sankt Gallen, 9007

Other trials in Switzerland

Romania2 sites

GSK Investigational Site
Bucharest, 030303
GSK Investigational Site
Iași, 700116

Other trials in Romania

Austria1 site

GSK Investigational Site
Vienna, A-1090

Other trials in Austria

Latvia1 site

GSK Investigational Site
Riga, LV 1006

Other trials in Latvia

Luxembourg1 site

GSK Investigational Site
Luxembourg, 1210

Other trials in Luxembourg

Portugal1 site

GSK Investigational Site
Cascais, 2750

Other trials in Portugal

About this study

Official title: See Detailed Description

Read the detailed description

A Phase IIIB, Randomized, Open-Label, Multicenter Study of the Safety and Efficacy of GW433908 (700mg BID) plus ritonavir (100mg BID) Versus Lopinavir/ritonavir (400mg/100mg BID) when Administered in Combination with the Abacavir/Lamivudine (600mg/300mg) Fixed-Dose Combination Tablet QD in Antiretroviral-Naive HIV-1 Infected Adults Over 48 Weeks

Conditions: HIV Infection, Infection, Human Immunodeficiency Virus
Being tested: LEXIVA (GW433908), Ritonavir, KALETRA, EPIVIR, Ziagen
Keywords: ritonavir, abacavir, HIV, lopinavir, lamivudine, fosamprenavir, Epzicom
Medical subject headings: HIV Infections, Infections, Acquired Immunodeficiency Syndrome

What participants receive

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

LEXIVA (GW433908)Drug
RitonavirDrug
KALETRADrug
EPIVIRDrug
ZiagenDrug
Abacavir/LamivudineDrug
FosamprenavirDrug
Also called LEXIVA (GW433908), Ritonavir, Ziagen, KALETRA

What is being measured

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

Proportion of subjects with plasma HIV-1 RNA <400 copies/mL at Week 48. Proportion of subjects who permanently discontinue randomized treatment due to adverse events.

Secondary outcomes (1)

Proportion of subjects with plasma HIV-1 RNA <400 copies/mL at Week 48. Proportion of subjects who permanently discontinue randomized treatment due to adverse events.

Timeline

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

May 2004?

First posted21 Jun 2004 (estimated)
Study startMay 2004

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for HIV InfectionStudies 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: 866 participants

IDs, dates and publications

ClinicalTrials.gov ID: NCT00085943
Sponsor's protocol ID: 100732
Status last verified: May 2011
First submitted: 17 Jun 2004
Last updated: 16 May 2011
Results posted: No
Data monitoring committee: No

Publications

Eron J Jr, Yeni P, Gathe J Jr, Estrada V, DeJesus E, Staszewski S, Lackey P, Katlama C, Young B, Yau L, Sutherland-Phillips D, Wannamaker P, Vavro C, Patel L, Yeo J, Shaefer M; KLEAN study team. The KLEAN study of fosamprenavir-ritonavir versus lopinavir-ritonavir, each in combination with abacavir-lamivudine, for initial treatment of HIV infection over 48 weeks: a randomised non-inferiority trial. Lancet. 2006 Aug 5;368(9534):476-82. doi: 10.1016/S0140-6736(06)69155-1.
PubMed 16890834

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 Infection trials

Study at a glance

From the registry record, last updated by the sponsor on 16 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: See Detailed Description
ClinicalTrials.gov ID: NCT00085943
Acronym / sponsor ID: 100732
Conditions: HIV Infection, Infection, Human Immunodeficiency Virus
Keywords: ritonavir, abacavir, HIV, lopinavir, lamivudine, fosamprenavir, Epzicom
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 866 participants
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: May 2004
First posted: 21 Jun 2004 (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.

Detailed description

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: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

HIV infected subjects that are naive to anti-HIV therapy.
History of a positive HIV test.
At least 1000 copies/mL of HIV in their blood as screening.

Key exclusion criteria (4 listed)

Active HIV-related diseases.
Taking other investigational drugs.
Pregnant or breastfeeding females.
Not be suitable to participate per investigator opinion.

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
LEXIVA (GW433908)	Drug	–
Ritonavir	Drug	–
KALETRA	Drug	–
EPIVIR	Drug	–
Ziagen	Drug	–
Abacavir/Lamivudine	Drug	–
FosamprenavirAlso: LEXIVA (GW433908), Ritonavir, Ziagen, KALETRA	Drug	–

Primary outcome

Proportion of subjects with plasma HIV-1 RNA <400 copies/mL at Week 48. Proportion of subjects who permanently discontinue randomized treatment due to adverse events.

1 secondary outcome

Proportion of subjects with plasma HIV-1 RNA <400 copies/mL at Week 48. Proportion of subjects who permanently discontinue randomized treatment due to adverse events.

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 16 May 2011.
Background: PubMed 16890834Eron J Jr, Yeni P, Gathe J Jr, Estrada V, DeJesus E, Staszewski S, Lackey P, Katlama C, Young B, Yau L, Sutherland-Phillips D, Wannamaker P, Vavro C, Patel L, Yeo J, Shaefer M; KLEAN study team. The KLEAN study of fosamprenavir-ritonavir versus lopinavir-ritonavir, each in combination with abacavir-lamivudine, for initial treatment of HIV infection over 48 weeks: a randomised non-inferiority trial. Lancet. 2006 Aug 5;368(9534):476-82. doi: 10.1016/S0140-6736(06)69155-1.

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Not yet recruiting
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Recruiting
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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.

GSK Clinical Trials, Pharm.D. study director

GlaxoSmithKline

119 sites in 14 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing LEXIVA (GW433908), Ritonavir and KALETRA in people with HIV Infection and Infection, Human Immunodeficiency Virus, run by GlaxoSmithKline at 119 sites in 14 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 3 inclusion and 4 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 16 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 119 sites in United States, Spain, France, Canada, Germany and 9 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.

What does the primary outcome measure?

Proportion of subjects with plasma HIV-1 RNA <400 copies/mL at Week 48. Proportion of subjects who permanently discontinue randomized treatment due to adverse events.. 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 NCT00085943, which also lists 1 linked publication.

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 16 May 2011.