A Study of an Oral Entry Inhibitor, SP01A, in Treatment-Experienced HIV-Infected Patients
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||A Multi-Center, Double-Blind, Randomized, Placebo-Controlled Study Of Orally Administered SP01A As Monotherapy Treatment Of HIV-Infected Patients|
- The primary objective of this study is to assess the dose-response, efficacy, and safety of orally administered SP01A as monotherapy treatment in HIV-infected patients with evidence of resistance to currently available antiretroviral therapy.
|Study Start Date:||May 2005|
This is a multi-center, double-blind, randomized, placebo controlled Phase II study of orally administered SP01A as monotherapy treatment in HIV-infected patients with evidence of resistance to currently available antiretroviral therapy. This monotherapy study focuses on HIV-infected subjects who have previously failed antiretroviral regimens (treatment failures; defined as individuals with evidence of their viral load going up despite taking their anti-HIV drugs precisely as prescribed).
HIV-positive subjects will be evaluated during the pre-study period. Following a 4-week washout period (to ensure that any previous anti-HIV drug no longer remains in their system), all study groups will initiate the 10-day monotherapy study.
At the conclusion of the 10-day monotherapy study, subjects will have the option of having testing to determine the best anti-HIV treatment combination for their further treatment. Further treatment, if indicated, will be limited to FDA-approved anti-HIV treatments.
The primary objective of this study is to assess the dose-response, efficacy and safety of orally administered SP01A as monotherapy treatment (study drug alone) of HIV-infected subjects with evidence of resistance to currently available anti-HIV drug therapy.
The primary analysis is the reduction in viral load (log10) within each SP01A study arm as well as within the placebo arm as measured from the first day of drug administration (DAY-1 (Baseline)) to the last day of study drug administration (DAY-11 (Study-End)).
The secondary analysis is the reduction in viral load (log10) across SP01A active arms measured from DAY-1 (Baseline) to DAY-11 (Study-End).
The investigators may also test the HIV in each patient's blood to determine if one or more HIV strains exists that are resistant to currently approved anti-HIV drugs. This testing will be conducted at DAY-1 and Day-11. Additionally, the investigators may test to determine whether the virus develops resistance to the study drug on DAY-11.
Safety will be assessed at each visit by laboratory evaluations, physical examination and/or questioning for side effects. In the event of side effects, dosing of study drug may be stopped according to provisions outlined in the protocol.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00113412
|United States, Florida|
|Therafirst Medical Centers|
|Fort Lauderdale, Florida, United States, 33308|
|BioCollections Worldwide, Inc.|
|Miami, Florida, United States, 33137|
|Orlando Immunology Center|
|Orlando, Florida, United States, 32803|
|Infectious Disease Research Institute|
|Tampa, Florida, United States, 33614|
|United States, Pennsylvania|
|Anderson Medical Group|
|Pittsburgh, Pennsylvania, United States, 15206|
|United States, Texas|
|Tarant County Infectious Disease|
|Fort Worth, Texas, United States, 76104|
|University of Texas Health Science Center|
|Houston, Texas, United States, 77009|
|Study Director:||Erasto Saldi, MD||Samaritan Pharmaceuticals, Inc|