KALETRA Or LEXIVA With Ritonavir Combined With EPIVIR And Abacavir In Naive Subjects Over 48 Weeks - Full Text View

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00085943

Purpose

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.

Condition	Intervention	Phase
HIV Infection	Drug: LEXIVA (GW433908) Drug: Ritonavir Drug: KALETRA Drug: EPIVIR Drug: Ziagen Drug: Abacavir/Lamivudine Drug: Fosamprenavir	Phase III

MedlinePlus related topics: AIDS

Drug Information available for: Abacavir Abacavir sulfate Lamivudine Ritonavir Lopinavir Fosamprenavir Fosamprenavir calcium Fosamprenavir sodium Abacavir-lamivudine combination

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Official Title:	See Detailed Description

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

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 Outcome Measures:

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.

Estimated Enrollment:	866
Study Start Date:	May 2004

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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00085943

Show 122 Study Locations

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, Pharm.D.

GlaxoSmithKline

More Information

Publications indexed to this study:

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.

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	100732, KLEAN Study
Study First Received:	June 17, 2004
Last Updated:	October 16, 2008
ClinicalTrials.gov Identifier:	NCT00085943
Health Authority:	United States: Food and Drug Administration; Germany: Federal Institute for Drugs and Medical Devices; Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by GlaxoSmithKline:

HIV
abacavir
lamivudine
fosamprenavir

lopinavir
ritonavir
Epzicom

Study placed in the following topic categories:

Virus Diseases
Sexually Transmitted Diseases, Viral
Fosamprenavir
Lopinavir
Ritonavir
HIV Infections

Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Lamivudine
Abacavir
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:

Anti-Infective Agents
HIV Protease Inhibitors
RNA Virus Infections
Anti-HIV Agents
Slow Virus Diseases
Immune System Diseases
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Infection

Antiviral Agents
Pharmacologic Actions
Protease Inhibitors
Reverse Transcriptase Inhibitors
Anti-Retroviral Agents
Therapeutic Uses
Lentivirus Infections
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on January 16, 2009