Trial intelligence / Profile preview

SP01A Monotherapy in HIV-Infected Patients

NCT00299897Phase 2

Key facts

Status
Unknown
Start
Mar 2006
Countries
1
Modality
Small Molecules
Conditions
human immunodeficiency virus infection (HIV)
01

Overview

Phase 2, randomised, double-blind trial of procaine in human immunodeficiency virus infection (HIV) (4 arms), sponsored by Samaritan Pharmaceuticals, Inc. Primary endpoint: Within treatment group reduction in viral load (log10) at Day 29. Status: unknown.

02

Design

4 arms
Study design
RandomizedDouble-blind
  • SP01A 200 mg QID

    SP01A 200 mg administered four times daily

  • SP01A 200 mg BID

    SP01A 200 mg administered twice daily

  • SP01A 400 mg BID

    SP01A 400 mg administered twice daily

  • Placebo BID

    Placebo administered twice daily

03

Endpoints

Primary

  • Within treatment group reduction in viral load (log10)

Secondary

  • Reduction in viral load compared across SP01A active arms

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