Status:
UNKNOWN
SP01A: The Study of an Oral Entry Inhibitor in Treatment-Experienced HIV Patients
Lead Sponsor:
Samaritan Pharmaceuticals, Inc
Conditions:
HIV Infections
Human Immunodeficiency Virus
Eligibility:
All Genders
18-60 years
Phase:
PHASE2
Brief 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 subject...
Detailed Description
Currently approved antiretroviral medications target either the HIV viral reverse transcriptase (RT), (Nucleoside Reverse Transcriptase Inhibitors (NRTIs) and Non-Nucleoside Reverse Transcriptase Inhi...
Eligibility Criteria
Inclusion
- Prior to the first day of study drug:
- Patient must be capable of giving informed consent prior to the screening visit.
- Patient is HIV-positive and has treatment-experienced virologic failure or documented resistance. Treatment-experienced virologic failure is defined as patients meeting the following criteria; (1) previous experience with antiretroviral therapy from at least two of the approved antiretroviral classes (i.e. treatment with a nucleoside reverse transcriptase inhibitor, and/or non-nucleoside reverse transcriptase inhibitor, and/or protease inhibitor) for three to six months; (2) increasing HIV RNA after treatment had previously lowered viral load to low or undetectable levels; (3) increased viremia (HIV RNA \> 5,000 copies/mL) in at least two viral load tests, one of which can be the screening viral load test, confirming their failing regimen. A patient that is currently on a stable antiretroviral regimen that is successfully suppressing or maintaining viremia at low detectable levels (HIV RNA \< 5,000 copies/mL) is not eligible for entry into the study.
- Patient has been off all antiviral medications including any unapproved or experimental treatment for at least 2 weeks prior to Study Day-1 (baseline).
- Patient has not taken any experimental medications for at least 4 weeks prior to Screening.
- Patient is at least 18 years of age and not older than 60 years of age.
- Patient is capable of adhering to the protocol.
- Patient has a CD4+ count \>/= 100 copies/mL.
- Patient has a viral load of \> 5000 copies/mL.
- Patient has a Karnofsky score \>/= 60.
- Female patients that are of childbearing potential; (1) have a negative urine pregnancy test at screening, and agree to use a condom and another form of contraception (dual contraception) from the start of the study; or (2) are incapable of becoming pregnant.
Exclusion
- Patients are ineligible to participate in the study if ANY of the following criteria are met.
- Patients with known or suspected allergy to procaine hydrochloride.
- Patients that must take oral or injectable anticholinesterase inhibitors (alone or in combination) for the treatment of myasthenia gravis or as a reversal agent or antagonist to nondepolarizing muscle relaxants such as curariform drugs. Patients using eye medications for glaucoma are not excluded from the study.
- Patients with SGOT (AST) baseline value \>3 times upper limit.
- Patients with SGPT (ALT) baseline value \>3 times upper limit.
- Patients with Creatinine \>2.0 mg/dl.
- Patients with Absolute Neutrophil count \<1,000 cells/mm3.
- Patients with Platelets baseline value \<75,000 cells/µl.
- Patients that currently have any active opportunistic infection. Prophylaxis for MAI, CMV, PCP, or Herpes is permitted.
- Females that are pregnant or breast feeding.
- Female patients of childbearing age who cannot either use dual contraception or abstain from sexual intercourse during the clinical study.
- Patients with less than 6 months life expectancy.
- Patients with active hepatitis (viral or drug induced).
- Patients with cancer, except peripheral (dermal) Kaposi's sarcoma.
- Patients on dialysis.
- Patients that currently have an active alcohol or substance abuse.
- Patients with any medical, psychological, psychiatric or substance use problem that, in the opinion of the principal investigator, will interfere with the patient's ability to complete the study.
- A patient that is currently on a stable antiretroviral regimen that is successfully suppressing or maintaining viremia at low detectable levels (HIV RNA \< 5,000 copies/mL) is not eligible for entry into the study.
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00299897
Start Date
March 1 2006
Last Update
October 27 2006
Active Locations (5)
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1
AIDS Healthcare Foundation
Beverly Hills, California, United States, 90211
2
Therafirst Medical Centers
Fort Lauderdale, Florida, United States, 33308
3
Infectious Disease of Central Florida
Orlando, Florida, United States, 32806
4
Triple O Medical Servcies
West Palm Beach, Florida, United States, 33401-3429