101
Participants
Start Date
July 31, 2008
Primary Completion Date
August 31, 2010
Study Completion Date
July 31, 2011
Efavirenz 600mg
"QD regimen of Sustiva (efavirenz 600 mg) + Epzicom (abacavir 600 mg / lamivudine 300 mg)~The intervention may be switched for the following reasons:~* To resolve a Grade 3 or 4 Adverse Event~* The subject experienced a virologic failure (as defined in section 3.6.2)~* The investigator believes the subject is at a significant risk for failing to comply with the protocol AND the investigator believes a regimen substitution is likely to resolve the compliance issue~* The investigator believes there is any other significant safety concern for the subject associated with remaining on the current regimen (e.g., hypersensitivity reaction, increased risk of suicide)"
Boosted Lexiva
"Once daily (QD) regimen of Lexiva (fosamprenavir 1400 mg) + Norvir (ritonavir 100 mg) + Epzicom (abacavir 600 mg / lamivudine 300 mg)~The intervention may be switched for the following reasons:~* To resolve a Grade 3 or 4 Adverse Event~* The subject experienced a virologic failure (as defined in section 3.6.2)~* The investigator believes the subject is at a significant risk for failing to comply with the protocol AND the investigator believes a regimen substitution is likely to resolve the compliance issue~* The investigator believes there is any other significant safety concern for the subject associated with remaining on the current regimen (e.g., hypersensitivity reaction, increased risk of suicide)"
Georgetown University, Washington D.C.
Collaborators (1)
GlaxoSmithKline
INDUSTRY
Georgetown University
OTHER