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

June 23, 2005 updated by: Genentech, Inc.
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • South San Francisco, California, United States, 94080
        • Genentech Inc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Genentech, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

November 2, 1999

First Submitted That Met QC Criteria

August 30, 2001

First Posted (Estimate)

August 31, 2001

Study Record Updates

Last Update Posted (Estimate)

June 24, 2005

Last Update Submitted That Met QC Criteria

June 23, 2005

Last Verified

January 1, 1990

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 064B
  • Serial Number 002
  • CO036g

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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