SP01A: The Study of an Oral Entry Inhibitor in Treatment-Experienced HIV Patients
Status:
Unknown status
Trial end date:
1969-12-31
Target enrollment:
Participant gender:
Summary
This is a 28-day, multi-center, placebo-controlled study designed to look at the dose
response, efficacy, and safety of SP01A, given as a pill to be swallowed, in the treatment of
HIV-infected subjects.
Samaritan has discovered that SP01A affects cholesterol binding, which is directly implicated
in the pathogenesis of HIV. It has also been established that drugs of this nature exert an
anti-HIV effect in-vitro. These data suggest that SP01A has the potential to reduce HIV virus
replication.
One measurement of an HIV infected person's risk of progressing to AIDS is the number of
viral particles of HIV in their blood (called a "viral load"). This study is designed to see
if SP01A will lower the amount of HIV in an infected individual's blood. Patients will be
assigned by chance to 1 of 4 groups. Neither the patient nor the study doctor or nurse will
know which dose of the study drug the patient is taking or if he/she is receiving the placebo
(a capsule that looks like the study drug but does not contain any active ingredient).
Study drug administration will continue for 28 days. At the end of the 28-day study, the
patient will be offered testing of his/her virus for resistance to approved drugs (genotype).