NCT00299338

Brief Summary

This a Phase I/II non-randomized, open-label clinical study of 8 weeks duration using SP01A in HIV positive patients on a stable antiretroviral regimen. Dose response and safety associated with oral administration of four doses (200 mg, 400 mg, 600 mg, and 800 mg daily) of SP01A will be studied in a total of 24 study subjects. In addition, six HIV-negative subjects will be recruited as a control for cortisol secretion only and will not receive study medication.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at P25-P50 for phase_1 hiv-infections

Timeline
Completed

Started Sep 1997

Longer than P75 for phase_1 hiv-infections

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 1997

Completed
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2001

Completed
4.5 years until next milestone

First Submitted

Initial submission to the registry

March 2, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 6, 2006

Completed
Last Updated

April 3, 2006

Status Verified

March 1, 2006

First QC Date

March 2, 2006

Last Update Submit

March 31, 2006

Conditions

HIV Infections

Keywords

HIVAIDSCD4HAARTantiretroviraltreatment failureresistanceCCR4CXCR5gp120gp41cholesterollipid raftsintracellular fluidreceptorschemokineantigensTreatment Experienced

Outcome Measures

Primary Outcomes (3)

  • Mean viral load reduction (log10) over 8 weeks

  • Maximal viral load suppression (LDL <50 & 400) over 8 weeks

  • Cortisol reduction over 8 weeks

Secondary Outcomes (1)

  • Improvement in quality of life indices (Whalen Scale) over 8 weeks

Interventions

SP01ADRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Eighteen years of age or older (male or female).
  • If female, agreed to use suitable contraception to prevent pregnancy.
  • HIV positive as confirmed by viral load using nucleic acid sequence based amplification (NASBA), or enzyme-linked immunosorbent assay (ELISA) and Western Blot, for cohort A, B, C, and D. HIV negative by ELISA and Western blot for cohort E.
  • Karnofsky Performance Status score of at least 60.
  • No active opportunistic infection. Prophylaxis for MAl, CMV, Pneumocystis Pneumonia except Bactrim), or herpes was permitted.
  • Current CD4 count \>200.
  • Stable triple therapy antiretroviral regimen (cohorts A, B, C, and D) for the preceding 8 weeks and willing to make no changes in regimen during the study.
  • Not taking any unapproved or experimental treatment for HIV, including antiretrovirals and immune modulators (such as interferons or interleukins).
  • Capable and willing to provide informed consent.
  • Agreed not to take Epoetin during the trial.
  • Baseline laboratory values:
  • Neutrophils \> 1000 cells/mm3; Platelets \> 75,000 cells/mL; SGOT \<3 times upper limit of normal; SGPT \<3 times upper limit of normal; Creatinine \<2.0 mg/dL.

You may not qualify if:

  • Known or suspected allergy to procaine hydrochloride.
  • Patients taking DHEA supplementation or oral ketoconazole (which have anticortisol properties).
  • Patients using sulfonamides (including Septra/Bactrim).
  • Required use of sulfonamides, eg, Septra/Bactrim. (Procaine hydrochloride may inactivate sulfonamides).
  • 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 procaine hydrochloride, since procaine itself has some anti-cholinesterase activity.
  • Patients with less than 6 months life expectancy.
  • Patients with adrenal insufficiency (determined by screening ACTH stimulation test).
  • Patients with lymphoma.
  • Patients with active hepatitis (viral or drug induced).
  • Patients with cancer, except peripheral Kaposi's sarcoma.
  • Patients on dialysis.
  • Patients who are pregnant.
  • Female patients of childbearing age who can not use two forms of birth control or abstain from sexual intercourse during the trial.
  • Any medical, psychological, psychiatric, or substance use problem that, in the opinion of the Principal Investigator, interferes with the patient's ability to complete the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AIDS Research Alliance of West Hollywood

West Hollywood, California, 90069, United States

Location

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

  • Stephen J Brown, MD

    AIDS Research Alliance of West Hollywood

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 2, 2006

First Posted

March 6, 2006

Study Start

September 1, 1997

Study Completion

September 1, 2001

Last Updated

April 3, 2006

Record last verified: 2006-03

Locations

US(1)