A Phase I/II Clinical Study of WF 10 IV Solution ( TCDO ) in Patients With HIV Infection

June 23, 2005 updated by: Oxo Chemie GmbH
To evaluate the clinical toxicity, safety, and MTD of WF 10 ( TCDO ) intravenous solution administered to patients with HIV infection. To evaluate the potential anti-HIV activity of TCDO.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 1

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
    • Texas
      • Houston, Texas, United States, 77074
        • Oncol Med Associates

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

Concurrent Medication:

Required:

  • Aerosolized pentamidine (300 mg monthly) as prophylaxis for PCP only in patients with CD4 count <= 200 cells/mm3.

Allowed:

  • PCP prophylaxis with aerosolized pentamidine in patients with CD4 count > 200 cells/mm3, only at the discretion of the treating physician.

Patients must have:

  • HIV positivity.
  • Absolute CD4 count of 150 - 500 cells/mm3.
  • At least 6 months of prior zidovudine therapy.
  • No active opportunistic infection requiring ongoing therapy.
  • Life expectancy of at least 6 months.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

  • Neoplasm other than basal cell carcinoma of the skin.
  • Clinically significant cardiac disease.
  • Abnormal neurological status by a standardized assessment including strength, reflex testing, and sensory testing.
  • Unwilling to comply with protocol requirements.

Patients with the following prior conditions are excluded:

History of myocardial infarction or arrhythmias.

Prior Medication:

Excluded within 2 weeks prior to study entry:

  • Antiretroviral agent or interferon.
  • Systemic biologic response modifiers, corticosteroids, cytotoxic chemotherapeutic agents, or other drugs that can cause neutropenia or significant nephrotoxicity.
  • Rifampin or rifampin derivatives.
  • Systemic anti-infectives.

Required:

  • At least 6 months of prior zidovudine. Active drug or alcohol abuse.

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

Oxo Chemie GmbH

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

March 1, 1996

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 222A
  • WF10-92-US-001

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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