A Study of an Oral Entry Inhibitor, SP01A, in Treatment-Experienced HIV-Infected Patients
Status:
Unknown status
Trial end date:
1969-12-31
Target enrollment:
Participant gender:
Summary
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"). In a previous phase I/II
study, SP01A was observed to significantly lower the amount of HIV in blood, improve quality
of life (how well subject's felt), have a favorable safety profile (minimal side effects),
and be well tolerated. Moreover, in in vitro testing SP01A: (1) demonstrated comparable or
greater efficacy than currently approved anti-HIV drugs in preventing HIV virus replication;
(2) was observed to have minimal toxic effect on human cells; and (3) demonstrated
significant efficacy in preventing virus replication of HIV virus strains that resist
currently approved anti-HIV treatments. Based on these results, SP01A demonstrates promise as
a new and novel anti-HIV treatment.
The goal of this study is to further look at the dose response, efficacy, and safety of SP01A
as monotherapy, given as a capsule to be swallowed, in the treatment of HIV-infected
subjects. The investigators want to see if SP01A will lower the amount of HIV in blood.
Subjects will be assigned by chance to 1 of 4 groups. Neither the subject nor the study
doctor or nurse will know which dose of the study drug the subject is taking or if the
subject is receiving the placebo (a capsule that looks like the study drug but does not
contain any active ingredient).
At the end of the 10-day study, the subject will be offered testing of their virus for
resistance to approved drugs (genotype) and transferred to their physician for continued
treatment with FDA-approved antiretroviral therapies. If the subject experiences a side
effect, which continues past the end of the study, they will be further monitored until the
side effect goes away.