This open-label study will evaluate the safety, pharmacokinetics and antiviral activity of a modified Invirase (saquinavir)/ritonavir regimen in treatment-naïve HIV-1 infected patients. Patients will receive Invirase 500 mg plus ritonavir 100 mg twice daily orally for the first week, followed by Invirase 1000 mg plus ritonavir 100 mg twice daily orally for the second week. The study treatment will be given in combination with two Nucleoside Reverse Transcriptase Inhibitors (NRTIs), in accordance with the current clinical HIV treatment guidelines. Anticipated time on study treatment is 14 days.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
23
in accordance with current clinical HIV treatment guidelines
100 mg bid orally, Days 1-14
500 mg bid orally Days 1-7, 1000 mg bid orally Days 8-14
Unnamed facility
London, United Kingdom
Maximal increase in QTc interval (continuous Holter 12-lead ECG monitoring time points Days 1, 3, 4, 7, 10 and 14)
Time frame: 14 days
Pharmacokinetics: Plasma concentrations
Time frame: Pre-dose and 2, 4, 6, 8 and 12 hours post-dose, Days 3, 4, 7, 10 and 14
Pharmacodynamics: Change in HIV-RNA levels
Time frame: from baseline to Day 14
Safety: Incidence of adverse events
Time frame: approximately 6 months
Change in ECG parameters
Time frame: from baseline to Day 14
Correlation between saquinavir plasma concentration and QTc interval changes
Time frame: approximately 6 months
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