A Study of WF 10 IV Solution in Patients With Advanced HIV Disease
NCT ID: NCT00002152
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
PHASE2
60 participants
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
DOUBLE
Interventions
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WF10
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Oxo Chemie GmbH
INDUSTRY
Locations
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Nashville Health Management Foundation / Vanderbilt Univ
Nashville, Tennessee, United States
Countries
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References
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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. doi: 10.1007/BF02962364.
Other Identifiers
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WF10-94-US-002
Identifier Type: -
Identifier Source: secondary_id
222B
Identifier Type: -
Identifier Source: org_study_id