SP01A: The Study of an Oral Entry Inhibitor in Treatment-Experienced HIV Patients
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).
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||A Multi-Center, Double-Blind, Randomized, Placebo-Controlled Study of Orally Administered SP01A for 28 Days as Monotherapy Treatment in HIV-Infected Patients With Evidence of Resistance to Currently Available Antiretroviral Therapy|
- Within treatment group reduction in viral load (log10) in each SP01A active arm as well as within the placebo arm as measured from DAY-1 (Baseline) to DAY-22, and DAY-29 (Study-End).
- Reduction in viral load compared across SP01A active arms measured from DAY-1 (Baseline) to DAY-22 and DAY-29 (Study-End).
|Study Start Date:||March 2006|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00299897
|United States, California|
|AIDS Healthcare Foundation|
|Beverly Hills, California, United States, 90211|
|United States, Florida|
|Therafirst Medical Centers|
|Fort Lauderdale, Florida, United States, 33308|
|Infectious Disease of Central Florida|
|Orlando, Florida, United States, 32806|
|Triple O Medical Servcies|
|West Palm Beach, Florida, United States, 33401-3429|
|United States, Pennsylvania|
|Anderson Medical Group|
|Pittsburgh, Pennsylvania, United States, 15206|
|Study Director:||Robert S Musni, MD||Medical Director, Samaritan Pharmaceuticals|