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

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00085943
First received: June 17, 2004
Last updated: May 12, 2011
Last verified: May 2011

June 17, 2004
May 12, 2011
May 2004
Not Provided
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.
Not Provided
Complete list of historical versions of study NCT00085943 on ClinicalTrials.gov Archive Site
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.
Not Provided
Not Provided
Not Provided
 
KALETRA Or LEXIVA With Ritonavir Combined With EPIVIR And Abacavir In Naive Subjects Over 48 Weeks
See Detailed Description

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.

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

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • HIV Infection
  • Infection, Human Immunodeficiency Virus
  • Drug: LEXIVA (GW433908)
  • Drug: Ritonavir
  • Drug: KALETRA
  • Drug: EPIVIR
  • Drug: Ziagen
  • Drug: Abacavir/Lamivudine
  • Drug: Fosamprenavir
    Other Names:
    • LEXIVA (GW433908)
    • Ritonavir
    • Ziagen
    • KALETRA
    • Abacavir/Lamivudine
    • Fosamprenavir
    • EPIVIR
Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
866
Not Provided
Not Provided

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.
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States,   Austria,   Belgium,   Canada,   France,   Germany,   Italy,   Latvia,   Luxembourg,   Poland,   Portugal,   Romania,   Spain,   Switzerland
 
NCT00085943
100732
No
Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials, Pharm.D. GlaxoSmithKline
GlaxoSmithKline
May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP