At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Study in Underrepresented Patient Population or Regimen Tolerability: SUPPoRT
In Brief
A Phase 3 clinical trial evaluating Efavirenz 600mg and Boosted Lexiva for Human Immunodeficiency Virus Infections. Completed, enrolled 101 participants across 1 site.
Detailed Summary
The hope of this study is to gather data and information about the tolerability and effectiveness of Lexiva versus Sustiva in patients who have have been generally underrepresented in clinical trials.
Study Details
Timeline
Interventions
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)
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)