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A Phase I Study of Recombinant CD4(rCD4) in Patients With AIDS and AIDS-Related Complex

Sponsor
Genentech, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT00002005
Collaborator
(none)
1
Location

Study Details

Study Description

Brief Summary

To determine the safety profile and maximum tolerated dose (MTD) of recombinant soluble human CD4 (rCD4) therapy in patients with AIDS or AIDS related complex (ARC). To obtain a preliminary indication of the antiviral effects of rCD4 in patients with AIDS and ARC. To measure steady state serum levels of rCD4 following continuous infusion therapy.

Condition or Disease Intervention/Treatment Phase
  • Drug: CD4 Antigens
 N/A

Study Design

Study Type:
Interventional
Primary Purpose:
Treatment
Official Title:
A Phase I Study of Recombinant CD4(rCD4) in Patients With AIDS and AIDS-Related Complex

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 0 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    Inclusion Criteria

    Patients must have:

    • HIV-1 seropositivity.

    • Diagnosis of AIDS or AIDS related complex (ARC).

    • Failure to tolerate or respond to zidovudine (AZT) or decided to decline AZT therapy.

    • The ability to sign a written informed consent form prior to treatment.

    • A willingness to abstain from all other experimental therapy for HIV infection during the entire study period.

    • A life expectancy of at least 3 months.

    Exclusion Criteria

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

    • Serious active opportunistic infections.

    • Malignancies other than Kaposi's sarcoma.

    Concurrent Medication:
    Excluded:

    • Zidovudine (AZT).

    • Corticosteroids.

    • Nonsteroidal anti-inflammatory agents (NSAI).

    • Other experimental therapy.

    Patients with the following are excluded:

    • Serious active opportunistic infections.

    • Malignancies other than Kaposi's sarcoma.

    Prior Medication:
    Excluded within 3 weeks of study entry:

    • Zidovudine (AZT).

    • Chemotherapy.

    • Immunomodulators.

    • Other experimental therapy.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Genentech Inc South San Francisco California United States 94080

    Sponsors and Collaborators

    • Genentech, Inc.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00002005
    Other Study ID Numbers:
    • 064B
    • CO036g
    • Serial Number 002
    First Posted:
    Aug 31, 2001
    Last Update Posted:
    Jun 24, 2005
    Last Verified:
    Jan 1, 1990
    Keywords provided by , ,
    Acquired Immunodeficiency Syndrome
    Antigens, CD4
    AIDS-Related Complex
    Additional relevant MeSH terms:
    AIDS-Related Complex

    Study Results

    No Results Posted as of Jun 24, 2005