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Sponsored by: |
Oxo Chemie GmbH |
Information provided by: | NIH AIDS Clinical Trials Information Service |
ClinicalTrials.gov Identifier: | NCT00002152 |
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.
Condition | Intervention | Phase |
HIV Infections |
Drug: WF10 |
Phase II |
MedlinePlus related topics: | AIDS |
Study Type: | Interventional |
Study Design: | Treatment, Double-Blind, Safety Study |
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 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
Allowed:
Patients must have:
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
Concurrent Medication:
Excluded:
Patients with the following prior conditions are excluded:
History of myocardial infarction or arrhythmias.
Prior Medication:
Excluded within 2 weeks prior to study entry:
Excluded within 30 days prior to study entry:
Prior Treatment:
Excluded within 2 weeks prior to study entry:
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)
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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)
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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.
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Study ID Numbers: | 222B, WF10-94-US-002 |
First Received: | November 2, 1999 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00002152 |
Health Authority: | United States: Food and Drug Administration |
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