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

Phase 3

Completed

• Conditions: HIV Infection; Infection, Human Immunodeficiency Virus

• Registration Number: NCT00085943
• Lead Sponsor: GlaxoSmithKline

Brief 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.

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

Study Timeline

• Study Start: 2004-05
• Study First Submitted: 2004-06-17
• Study First Submitted QC: 2004-06-18
• Study First Posted: 2004-06-21
• Status Verified: 2011-05
• Last Update Submitted: 2011-05-12
• Last Update Posted: 2011-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 866

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

GSK Investigational Site; 🇨🇭 St Gallen, Switzerland