A Study in Underrepresented Patient Population or Regimen Tolerability: SUPPoRT

PHASE3CompletedINTERVENTIONAL
Enrollment

101

Participants

Timeline

Start Date

July 31, 2008

Primary Completion Date

August 31, 2010

Study Completion Date

July 31, 2011

Conditions
Human Immunodeficiency Virus Infections
Interventions
DRUG

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)"

DRUG

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)"

Trial Locations (1)

20007

Georgetown University, Washington D.C.

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

GlaxoSmithKline

INDUSTRY

lead

Georgetown University

OTHER

NCT00727597 - A Study in Underrepresented Patient Population or Regimen Tolerability: SUPPoRT | Biotech Hunter | Biotech Hunter