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The Safety and Effectiveness of SPC3 in HIV-1 Infected Patients

Sponsor
Columbia Research Laboratories (Industry)
Overall Status
Completed
CT.gov ID
NCT00002363
Collaborator
(none)
20
Enrollment
1
Location

Study Details

Study Description

Brief Summary

To assess the effects of two doses of synthetic peptide construction 3 ( SPC3 ) on HIV-1 plasma levels (as measured by RNA PCR Amplicor) and on lymphocyte subsets in patients with initial viral load above 10,000 copies/ml. To study the safety of SPC3 and the kinetics of HIV-1 plasma level changes.

Condition or Disease Intervention/Treatment Phase
  • Drug: Peptide Construction 3, Synthetic
 Phase 1

Detailed Description

The first five patients receive SPC3 daily for 3 weeks. If that dose is tolerated, the dose is increased and given to the next 5 patients for 3 weeks. The remaining ten patients receive a dose of SPC3 based on response to the previous two dose levels. Patients are followed through day 28.

Study Design

Study Type:
Interventional
Primary Purpose:
Treatment
Official Title:
Study of the Safety and Effects of Two Doses of SPC3, Administered Daily Intravenously in HIV-1 Seropositive Patients

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    Inclusion Criteria

    Concurrent Medication:
    Allowed:
    • Antiretrovirals provided regimen has been stable for at least 6 weeks prior to study screening.
    Patients must have:

    • HIV seropositivity for at least 6 months.

    • CD4 >= 100 cells/mm3.

    • HIV RNA PCR (Amplicor) > 10,000 copies/ml.

    • No significant active opportunistic infection or tumor at study entry.

    FDA DISCLAIMER:
    • The FDA encourages the inclusion of females of childbearing potential in study protocols, but the sponsor of this protocol specifically excludes females of childbearing potential from this study and includes only females who are sterile. Any questions about these inclusion/exclusion criteria should be directed to the study's contact person.
    Prior Medication:
    Allowed:
    • Prior antiretrovirals.

    Exclusion Criteria

    Co-existing Condition:
    Patients with the following conditions are excluded:

    Inability to communicate with investigator or deemed likely to be noncompliant on study.

    Concurrent Medication:
    Excluded:
    • Any drug that may interact with SPC3 (e.g., suramin).
    Patients with the following prior condition are excluded:

    History of relevant drug hypersensitivity.

    Prior Medication:
    Excluded:
    • Investigational drug within the past 4 weeks.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Brown Univ School of Medicine Providence Rhode Island United States 02908

    Sponsors and Collaborators

    • Columbia Research Laboratories

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00002363
    Other Study ID Numbers:
    • 257A
    • SPC3-US1
    First Posted:
    Aug 31, 2001
    Last Update Posted:
    Jun 24, 2005
    Last Verified:
    Apr 1, 1999
    Keywords provided by , ,
    Acquired Immunodeficiency Syndrome
    AIDS-Related Complex
    Antiviral Agents
    Additional relevant MeSH terms:
    HIV Infections

    Study Results

    No Results Posted as of Jun 24, 2005