A Phase I/II Clinical Study of WF 10 IV Solution ( TCDO ) in Patients With HIV Infection
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Ages Eligible for Study:
18 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Aerosolized pentamidine (300 mg monthly) as prophylaxis for PCP only in patients with CD4 count <= 200 cells/mm3.
PCP prophylaxis with aerosolized pentamidine in patients with CD4 count > 200 cells/mm3, only at the discretion of the treating physician.
Patients must have:
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.
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.
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.
At least 6 months of prior zidovudine. Active drug or alcohol abuse.
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)
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)