A Phase I/II Clinical Study of WF 10 IV Solution ( TCDO ) in Patients With HIV Infection
NCT ID: NCT00002119
Last Updated: 2005-06-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
INTERVENTIONAL
Brief Summary
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Detailed Description
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Conditions
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Study Design
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TREATMENT
Interventions
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WF10
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Oxo Chemie GmbH
INDUSTRY
Locations
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Oncol Med Associates
Houston, Texas, United States
Countries
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References
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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)
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. doi: 10.1007/BF02962364.
Other Identifiers
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WF10-92-US-001
Identifier Type: -
Identifier Source: secondary_id
222A
Identifier Type: -
Identifier Source: org_study_id