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

HIV Infection Clinical Trial

Official title:

See Detailed Description

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00085943
• Other study ID #: 100732
• Status: Completed
• Phase: Phase 3
• First received: June 17, 2004
• Last updated: May 12, 2011
• Start date: May 2004

Study information

• Verified date: May 2011
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical DevicesAustralia: Department of Health and Ageing Therapeutic Goods AdministrationUnited States: Food and Drug Administration
• Study type: Interventional

Clinical 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. In addition we will study the safety and tolerability of these compounds over the 48 week study period in patients naive to anti-HIV therapy.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 866
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Active HIV-related diseases.

• Taking other investigational drugs.

• Pregnant or breastfeeding females.

• Not be suitable to participate per investigator opinion.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infection
• HIV Infections
• Immunologic Deficiency Syndromes
• Infection
• Infection, Human Immunodeficiency Virus

Intervention

Drug:
• LEXIVA (GW433908)

• Ritonavir

• KALETRA

• EPIVIR

• Ziagen

• Abacavir/Lamivudine

• Fosamprenavir

Locations

Country	Name	City	State
Austria	GSK Investigational Site	Vienna
Belgium	GSK Investigational Site	Bruxelles
Belgium	GSK Investigational Site	Charleroi
Belgium	GSK Investigational Site	Gent
Belgium	GSK Investigational Site	Leuven
Belgium	GSK Investigational Site	Liege
Belgium	GSK Investigational Site	Liège
Canada	GSK Investigational Site	Calgary	Alberta
Canada	GSK Investigational Site	Montreal	Quebec
Canada	GSK Investigational Site	Montreal	Quebec
Canada	GSK Investigational Site	Ottawa	Ontario
Canada	GSK Investigational Site	Toronto	Ontario
Canada	GSK Investigational Site	Toronto	Ontario
Canada	GSK Investigational Site	Toronto	Ontario
Canada	GSK Investigational Site	Toronto	Ontario
France	GSK Investigational Site	Bordeaux Cedex
France	GSK Investigational Site	Le Kremlin Bicêtre Cedex
France	GSK Investigational Site	Lyon Cedex 02
France	GSK Investigational Site	Lyon Cedex 03
France	GSK Investigational Site	Paris
France	GSK Investigational Site	Paris Cedex 10
France	GSK Investigational Site	Paris Cedex 13
France	GSK Investigational Site	Paris Cedex 14
France	GSK Investigational Site	Saint Denis Cedex 01
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Frankfurt	Hessen
Germany	GSK Investigational Site	Fuerth	Bayern
Germany	GSK Investigational Site	Hamburg
Germany	GSK Investigational Site	Hamburg
Germany	GSK Investigational Site	Hannover	Niedersachsen
Germany	GSK Investigational Site	Muenchen	Bayern
Italy	GSK Investigational Site	Busto Arsizio (VA)	Lombardia
Italy	GSK Investigational Site	Ferrara	Emilia-Romagna
Italy	GSK Investigational Site	Milano	Lombardia
Italy	GSK Investigational Site	Milano	Lombardia
Italy	GSK Investigational Site	Modena	Emilia-Romagna
Italy	GSK Investigational Site	Rimini	Emilia-Romagna
Italy	GSK Investigational Site	Torino	Piemonte
Latvia	GSK Investigational Site	Riga
Luxembourg	GSK Investigational Site	Luxembourg
Poland	GSK Investigational Site	Bydgoszcz
Poland	GSK Investigational Site	Szczecin
Poland	GSK Investigational Site	Wroclaw
Portugal	GSK Investigational Site	Cascais
Romania	GSK Investigational Site	Bucharest
Romania	GSK Investigational Site	Iasi
Spain	GSK Investigational Site	Barcelona
Spain	GSK Investigational Site	Elche (Alicante)
Spain	GSK Investigational Site	Madrid
Spain	GSK Investigational Site	Madrid
Spain	GSK Investigational Site	Madrid
Spain	GSK Investigational Site	Malaga
Spain	GSK Investigational Site	Palma de Mallorca
Spain	GSK Investigational Site	Sevilla
Spain	GSK Investigational Site	Tarrasa, Barcelona
Spain	GSK Investigational Site	Valencia
Spain	GSK Investigational Site	Vigo ( Pontevedra)
Switzerland	GSK Investigational Site	Lugano
Switzerland	GSK Investigational Site	Olten
Switzerland	GSK Investigational Site	St Gallen
United States	GSK Investigational Site	Atlanta	Georgia
United States	GSK Investigational Site	Atlanta	Georgia
United States	GSK Investigational Site	Baltimore	Maryland
United States	GSK Investigational Site	Birmingham	Alabama
United States	GSK Investigational Site	Boston	Massachusetts
United States	GSK Investigational Site	Boston	Massachusetts
United States	GSK Investigational Site	Bradenton	Florida
United States	GSK Investigational Site	Bronx	New York
United States	GSK Investigational Site	Bronx	New York
United States	GSK Investigational Site	Chapel Hill	North Carolina
United States	GSK Investigational Site	Charlotte	North Carolina
United States	GSK Investigational Site	Charlottesville	Virginia
United States	GSK Investigational Site	Chicago	Illinois
United States	GSK Investigational Site	Chicago	Illinois
United States	GSK Investigational Site	Chicago	Illinois
United States	GSK Investigational Site	Chicago	Illinois
United States	GSK Investigational Site	Columbia	South Carolina
United States	GSK Investigational Site	Dallas	Texas
United States	GSK Investigational Site	Dallas	Texas
United States	GSK Investigational Site	Denver	Colorado
United States	GSK Investigational Site	Durham	North Carolina
United States	GSK Investigational Site	Fort Lauderdale	Florida
United States	GSK Investigational Site	Fort Worth	Texas
United States	GSK Investigational Site	Greenville	North Carolina
United States	GSK Investigational Site	Hampton	Virginia
United States	GSK Investigational Site	Hillsborough	New Jersey
United States	GSK Investigational Site	Houston	Texas
United States	GSK Investigational Site	Houston	Texas
United States	GSK Investigational Site	Indianapolis	Indiana
United States	GSK Investigational Site	Indianapolis	Indiana
United States	GSK Investigational Site	Jackson	Mississippi
United States	GSK Investigational Site	Knoxville	Tennessee
United States	GSK Investigational Site	Lexington	Kentucky
United States	GSK Investigational Site	Los Angeles	California
United States	GSK Investigational Site	Lynchburg	Virginia
United States	GSK Investigational Site	Miami	Florida
United States	GSK Investigational Site	New York	New York
United States	GSK Investigational Site	Newark	New Jersey
United States	GSK Investigational Site	Orlando	Florida
United States	GSK Investigational Site	Pembroke Pines	Florida
United States	GSK Investigational Site	Philadelphia	Pennsylvania
United States	GSK Investigational Site	Philadelphia	Pennsylvania
United States	GSK Investigational Site	Phoenix	Arizona
United States	GSK Investigational Site	Providence	Rhode Island
United States	GSK Investigational Site	Rochester	New York
United States	GSK Investigational Site	Sacramento	California
United States	GSK Investigational Site	San Francisco	California
United States	GSK Investigational Site	Seattle	Washington
United States	GSK Investigational Site	Seattle	Washington
United States	GSK Investigational Site	Somers Point	New Jersey
United States	GSK Investigational Site	Spokane	Washington
United States	GSK Investigational Site	Stony Brook	New York
United States	GSK Investigational Site	Tampa	Florida
United States	GSK Investigational Site	Tampa	Florida
United States	GSK Investigational Site	Tampa	Florida
United States	GSK Investigational Site	Toledo	Ohio
United States	GSK Investigational Site	Voorhees	New Jersey
United States	GSK Investigational Site	Washington	District of Columbia
United States	GSK Investigational Site	Washington	District of Columbia
United States	GSK Investigational Site	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

United States,  Austria,  Belgium,  Canada,  France,  Germany,  Italy,  Latvia,  Luxembourg,  Poland,  Portugal,  Romania,  Spain,  Switzerland, 

References & Publications (1)

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. Erratum in: Lancet. 2006 Oct 7;368(9543):1238. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.