A Study of WF 10 IV Solution in Patients With Advanced HIV Disease
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
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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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Ages Eligible for Study:
18 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Approved drugs at a stabilized dose except those specifically excluded.
Aerosolized pentamidine (300 mg) once a month for PCP prophylaxis.
Patients must have:
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.
Patients with the following symptoms or conditions are excluded:
Neoplasm other than basal cell carcinoma of the skin.
Clinically significant cardiac disease.
Patients with the following prior conditions are excluded:
History of myocardial infarction or arrhythmias.
Excluded within 2 weeks prior to study entry:
Any antiretroviral agent.
Systemic therapy with biologic response modifiers, corticosteroids, cytotoxic chemotherapy, or neutropenic or nephrotoxic drugs.
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)