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

Condition(s) targeted: HIV Infections

Intervention: LEXIVA (GW433908) (Drug); Ritonavir (Drug); KALETRA (Drug); EPIVIR (Drug); Ziagen (Drug); Abacavir/Lamivudine (Drug); Fosamprenavir (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trials, Pharm.D., Study Director, Affiliation: GlaxoSmithKline

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.

Official title: 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 design: Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study

Primary outcome: 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: 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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

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Starting date: June 2004
Last updated: January 15, 2008