SP01A: The Study of an Oral Entry Inhibitor in Treatment-Experienced HIV Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2006 by Samaritan Pharmaceuticals, Inc.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Samaritan Pharmaceuticals, Inc
ClinicalTrials.gov Identifier:
NCT00299897
First received: March 3, 2006
Last updated: October 25, 2006
Last verified: October 2006
  Purpose

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).


Condition Intervention Phase
HIV Infections
Human Immunodeficiency Virus
Drug: SP01A
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:


Further study details as provided by Samaritan Pharmaceuticals, Inc:

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

Estimated Enrollment: 60
Study Start Date: March 2006
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Prior to the first day of study drug:

  1. Patient must be capable of giving informed consent prior to the screening visit.
  2. 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.
  3. Patient has been off all antiviral medications including any unapproved or experimental treatment for at least 2 weeks prior to Study Day-1 (baseline).
  4. Patient has not taken any experimental medications for at least 4 weeks prior to Screening.
  5. Patient is at least 18 years of age and not older than 60 years of age.
  6. Patient is capable of adhering to the protocol.
  7. Patient has a CD4+ count >/= 100 copies/mL.
  8. Patient has a viral load of > 5000 copies/mL.
  9. Patient has a Karnofsky score >/= 60.
  10. 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 Criteria:

Patients are ineligible to participate in the study if ANY of the following criteria are met.

  1. Patients with known or suspected allergy to procaine hydrochloride.
  2. 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.
  3. Patients with SGOT (AST) baseline value >3 times upper limit.
  4. Patients with SGPT (ALT) baseline value >3 times upper limit.
  5. Patients with Creatinine >2.0 mg/dl.
  6. Patients with Absolute Neutrophil count <1,000 cells/mm3.
  7. Patients with Platelets baseline value <75,000 cells/µl.
  8. Patients that currently have any active opportunistic infection. Prophylaxis for MAI, CMV, PCP, or Herpes is permitted.
  9. Females that are pregnant or breast feeding.
  10. Female patients of childbearing age who cannot either use dual contraception or abstain from sexual intercourse during the clinical study.
  11. Patients with less than 6 months life expectancy.
  12. Patients with active hepatitis (viral or drug induced).
  13. Patients with cancer, except peripheral (dermal) Kaposi’s sarcoma.
  14. Patients on dialysis.
  15. Patients that currently have an active alcohol or substance abuse.
  16. 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.
  17. 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00299897

Locations
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
Sponsors and Collaborators
Samaritan Pharmaceuticals, Inc
Investigators
Study Director: Robert S Musni, MD Medical Director, Samaritan Pharmaceuticals
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00299897     History of Changes
Other Study ID Numbers: SP01A-111-05
Study First Received: March 3, 2006
Last Updated: October 25, 2006
Health Authority: United States: Food and Drug Administration

Keywords provided by Samaritan Pharmaceuticals, Inc:
HIV
AIDS
Treatment Resistance
Treatment Failure
Mutations
GP120
Entry Inhibitors
HAART
antiretroviral
antiviral
ARV
CCR5
CXCR4
receptors
intracellular fluid
lipid rafts
cholesterol
chemokine
Treatment Experienced

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immunologic Deficiency Syndromes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on August 28, 2014