KALETRA Or LEXIVA With Ritonavir Combined With EPIVIR And Abacavir In Naive Subjects Over 48 Weeks
NCT00085943 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 866
Last updated 2011-05-16
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.
Conditions
- HIV Infection
- Infection, Human Immunodeficiency Virus
Interventions
- DRUG
-
LEXIVA (GW433908)
- DRUG
-
Ritonavir
- DRUG
-
KALETRA
- DRUG
-
EPIVIR
- DRUG
-
Ziagen
- DRUG
-
Abacavir/Lamivudine
- DRUG
-
Fosamprenavir
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
GSK Clinical Trials, Pharm.D. · GlaxoSmithKline
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2004-05-31
Countries
- United States
- Austria
- Belgium
- Canada
- France
- Germany
- Italy
- Latvia
- Luxembourg
- Poland
- Portugal
- Romania
- Spain
- Switzerland
Study Locations
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