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A Dose Response and Safety Study of Procaine HCl in HIV-Infected Patients

NCT00299338 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2006-04-03

No results posted yet for this study

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.

Conditions

  • HIV Infections

Interventions

DRUG

SP01A

Sponsors & Collaborators

  • Samaritan Pharmaceuticals, Inc

    lead INDUSTRY

Principal Investigators

  • Stephen J Brown, MD · AIDS Research Alliance of West Hollywood

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1997-09-30
Completion
2001-09-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00299338 on ClinicalTrials.gov