Study to determine the effects of 28 days of nevirapine treatment on the steady-state pharmacokinetics of amprenavir and of abacavir and to further evaluate the pharmacokinetics of nevirapine in combination with amprenavir and abacavir compared to historical controls treated with nevirapine but without amprenavir or abacavir. In addition safety/tolerance of nevirapine, amprenavir and abacavir was to be assessed based on adverse events and clinical laboratory data.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
8
AUC (area under plasma concentration time curve) of amprenavir in the absence and presence of nevirapine
Time frame: Day 14, day 43
Cmax (maximum observed concentration of the analyte in plasma) of amprenavir in the absence and presence of nevirapine
Time frame: Day 14, day 43
AUC (area under plasma concentration time curve) of abacavir in the absence and presence of nevirapine
Time frame: Day 14, day 43
Cmax (maximum observed concentration of the analyte in plasma) of abacavir in the absence and presence of nevirapine
Time frame: Day 14, day 43
Change from baseline in HIV-1 Ribonucleic Acid (RNA)
Time frame: Baseline, day 14, 21, 28, 35, 43 (Part I), up to 168 days (Part II)
Change from baseline in Lymphocytes Expressing CD4+ cell count
Time frame: Baseline, day 14, 21, 28, 35, 43 (Part I), up to 168 days (Part II)
Proportion of patients who achieved RNA levels below limit of quantification (BLoQ) (responders)
Time frame: up to 43 days (Part I), up to 168 days (Part II)
Number of patients with adverse events
Time frame: up to 240 days
Number of patients with abnormal changes in laboratory parameters
Time frame: Baseline, day 14, 28, 43 (Part I), up to 168 days (Part II)
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