A Study of WF 10 IV Solution in Patients With Advanced HIV Disease
Information source: NIH AIDS Clinical Trials Information Service
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: HIV Infections
Intervention: WF10 (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Oxo Chemie GmbH
Summary
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.
Clinical Details
Official 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
Study design: Treatment, Double-Blind, Safety Study
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Nashville Health Management Foundation / Vanderbilt Univ, Nashville, Tennessee 37203, United States
Additional Information
Related publications: Kahn JO, McGrath MS, Ching OM, Kuhne FW. A single center, phase 2 study evaluating the effects of WF10. Int Conf AIDS. 1998;12:349 (abstract no 22423) Busch HW, Christensen S, Reichelt D, Jahn S, Zidek W. Treatment of HIV-infected patients with advanced symptomatic disease with WF10 solution (TCDO). Int Conf AIDS. 1994 Aug 7-12;10(1):204 (abstract no PB0245) Raffanti SP, Schaffner W, Federspiel CF, Blackwell RB, Ching OA, Kuhne FW. Randomized, double-blind, placebo-controlled trial of the immune modulator WF10 in patients with advanced AIDS. Infection. 1998 Jul-Aug;26(4):202-7.
Last updated: June 23, 2005
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