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Completed

NCT Number: NCT00002152

A Study of WF 10 IV Solution in Patients With Advanced HIV Disease

The purpose of this study is to see if it is safe and effective to give WF 10 (TCDO) to patients with advanced HIV disease who cannot or will not take zidovudine, didanosine, zalcitabine, or stavudine. This study also examines how TCDO affects the levels of HIV in the body. TCDO is a solution delivered through a vein.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Nashville Health Management Foundation / Vanderbilt Univ

Nashville, Tennessee, 37203, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Concurrent Medication:

Allowed:

  • Approved drugs at a stabilized dose except those specifically excluded.
  • Aerosolized pentamidine (300 mg) once a month for PCP prophylaxis.

Patients must have:

  • HIV positivity.
  • Absolute CD4 count < 200 cells/mm3.
  • Intolerance to or refusal to take AZT, ddI, ddC, or d4T.
  • No active opportunistic infection requiring ongoing therapy.
  • Life expectancy at least 3 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.
  • Anemia.

Concurrent Medication:

Excluded:

  • Cytotoxic chemotherapy.
  • Corticosteroids.

Patients with the following prior conditions are excluded:

History of myocardial infarction or arrhythmias.

Prior Medication:

Excluded within 2 weeks prior to study entry:

  • Any antiretroviral agent.
  • Interferon.
  • Systemic therapy with biologic response modifiers, corticosteroids, cytotoxic chemotherapy, or neutropenic or nephrotoxic drugs.

Excluded within 30 days prior to study entry:

  • Investigational drugs.

Prior Treatment:

Excluded within 2 weeks prior to study entry:

  • Radiation therapy. Active drug or alcohol abuse.

Treatment and study plan

WF10

Drug

Sponsors and collaborators

Lead sponsor

Oxo Chemie GmbH

Industry

Registry information

Official study title

Randomized, Double-Blind, Placebo-Controlled Evaluation of the Safety and Efficacy of WF 10 IV Solution ( TCDO ) in the Management of Patients With Advanced HIV Disease

Important dates

First posted
Aug 31, 2001
Registry last updated
Jun 24, 2005

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.