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
  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
Infection, Human Immunodeficiency Virus
Drug: LEXIVA (GW433908)
Drug: Ritonavir
Drug: KALETRA
Drug: EPIVIR
Drug: Ziagen
Drug: Abacavir/Lamivudine
Drug: Fosamprenavir
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: See Detailed Description

Resource links provided by NLM:


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
Intervention Details:
    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
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Show 120 Study Locations
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials, Pharm.D. GlaxoSmithKline
  More Information

Publications:
Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT00085943     History of Changes
Other Study ID Numbers: 100732
Study First Received: June 17, 2004
Last Updated: May 12, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Australia: Department of Health and Ageing Therapeutic Goods Administration
United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
ritonavir
abacavir
HIV
lopinavir
lamivudine
fosamprenavir
Epzicom

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immunologic Deficiency Syndromes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immune System Diseases
Lamivudine
Abacavir
Ritonavir
Lopinavir
Fosamprenavir
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Anti-HIV Agents
HIV Protease Inhibitors
Protease Inhibitors

ClinicalTrials.gov processed this record on July 26, 2014