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

GlaxoSmithKline866 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

866

Conditions

HIV Infection Infection, Human Immunodeficiency Virus

Interventions

LEXIVA (GW433908)DRUG

RitonavirDRUG

KALETRADRUG

EPIVIRDRUG

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (119)

Outcomes

Primary Outcomes

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 Outcomes

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.

Data from ClinicalTrials.gov

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GSK Investigational Site

Birmingham, Alabama, United States

GSK Investigational Site

Phoenix, Arizona, United States

GSK Investigational Site

Los Angeles, California, United States

GSK Investigational Site

Sacramento, California, United States

GSK Investigational Site

San Francisco, California, United States

GSK Investigational Site

Denver, Colorado, United States

GSK Investigational Site

Washington D.C., District of Columbia, United States

GSK Investigational Site

Washington D.C., District of Columbia, United States

GSK Investigational Site

Washington D.C., District of Columbia, United States

GSK Investigational Site

Bradenton, Florida, United States

...and 109 more locations