A Study of an Oral Entry Inhibitor, SP01A, in Treatment-Experienced HIV-Infected Patients

Exclusion Criteria

• •Patient has been off all anti-viral medications, including any unapproved or experimental treatment for HIV and antiretrovirals, for at least 4 weeks prior to Study Day-1 (baseline). The patient may initiate this 4 week period after screening, if, in the judgment of the principal investigator, the patient qualifies for the study.
• •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 \>50 cells/ml.
• •Patient has a viral load of \> 5000 copies/ml.
• •Patient has a Karnofsky score greater than or equal to 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 from the start of the study; or (2) are incapable of becoming pregnant.
• •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 using sulfonamides (including Septra/Bactrim). Sulfonamides should not be used while on SP01A, because procaine will inactivate it. If a patient must be treated with Septra/Bactrim, that patient will be removed from the study.
• •Patients with glaucoma using anti-cholinesterase inhibitors (Humorsol \[demecarium bromide\] echothiophate iodide, Floropryl \[isoflurophate\], Isopto-Eserine \[physostigmine salicylate\]). Anti-cholinesterase inhibitors should not be used while on SP01A, since anticholinesterases inhibit the breakdown of procaine hydrochloride.
• •Patients with SGOT baseline value \>3 times upper limit.
• •Patients with SGPT 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 Mycobacterium avium intracellulare (MAI), cytomegalovirus (CMV), Pneumocystis carinii pneumonia (PCP), or herpes is permitted (excluding treatment with Sulfonamides).
• •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 problem.
• •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.