NCT00299897

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 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).

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for phase_2 hiv-infections

Geographic Reach
1 country

5 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2006

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

March 3, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 7, 2006

Completed
Last Updated

October 27, 2006

Status Verified

October 1, 2006

First QC Date

March 3, 2006

Last Update Submit

October 25, 2006

Conditions

HIV InfectionsHuman Immunodeficiency Virus

Keywords

HIVAIDSTreatment ResistanceTreatment FailureMutationsGP120Entry InhibitorsHAARTantiretroviralantiviralARVCCR5CXCR4receptorsintracellular fluidlipid raftscholesterolchemokineTreatment Experienced

Outcome Measures

Primary Outcomes (1)

  • 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).

Secondary Outcomes (1)

  • Reduction in viral load compared across SP01A active arms measured from DAY-1 (Baseline) to DAY-22 and DAY-29 (Study-End).

Interventions

SP01ADRUG

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

AIDS Healthcare Foundation

Beverly Hills, California, 90211, United States

Location

Therafirst Medical Centers

Fort Lauderdale, Florida, 33308, United States

Location

Infectious Disease of Central Florida

Orlando, Florida, 32806, United States

Location

Triple O Medical Servcies

West Palm Beach, Florida, 33401-3429, United States

Location

Anderson Medical Group

Pittsburgh, Pennsylvania, 15206, United States

Location

Related Publications (1)

  • Xu J, Lecanu L, Han Z, Yao Z, Greeson J, Papadopoulos V. Inhibition of adrenal cortical steroid formation by procaine is mediated by reduction of the cAMP-induced 3-hydroxy-3-methylglutaryl-coenzyme A reductase messenger ribonucleic acid levels. J Pharmacol Exp Ther. 2003 Dec;307(3):1148-57. doi: 10.1124/jpet.103.055178. Epub 2003 Oct 14.

    PMID: 14560037BACKGROUND

MeSH Terms

Conditions

HIV InfectionsAcquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesSlow Virus Diseases

Study Officials

  • Robert S Musni, MD

    Medical Director, Samaritan Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 3, 2006

First Posted

March 7, 2006

Study Start

March 1, 2006

Last Updated

October 27, 2006

Record last verified: 2006-10

Locations

US(5)