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A Study of WF 10 IV Solution in Patients with Advanced HIV Disease



A Study of WF 10 IV Solution in Patients with Advanced HIV Disease

For Condition: HIV Infections
Status: Completed
Sponsor(s): Oxo Chemie GmbH ,
Synopsis: 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.
Details:
Eligibility:
Study Type:  Interventional, Treatment, Double-Blind, Safety Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Concurrent Medication: 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 Co-existing Condition: 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.
Total Enrollment: 60

Location and Contact Information:

Nashville Health Management Foundation / Vanderbilt Univ
Nashville,  Tennessee,  37203
United States
 


Additional Information:
Study ID Numbers:  222B;  WF10-94-US-002
Study Start Date: 
Record last reviewed: March 1996
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002152

Other Hiv Infections Studies:
1. Depo-Medroxyprogesterone Acetate (DMPA, Depo-Provera) Use with Certain Anti-HIV Drugs in HIV-Infected Women

2. A Trial of Two Doses of 2',3'-Dideoxycytidine (ddC) in the Treatment of Children With Symptomatic HIV Infection Who Are Intolerant of AZT and/or Who Show Progressive Disease While on AZT

3. Evaluation of the Therapeutic Benefit of r-metHuIFN- gamma in AIDS Patients With Disseminated Mycobacterium Avium-Intracellulare (MAI) Infection: A Multi-Centered Pilot Study

4. An Open-Label Study in HIV+ Patients to Determine the Effects of Nevirapine (Viramune) on the Pharmacokinetics of Clarithromycin and Activity of Cytochrome 3A4.

5. Effects of BufferGel and PRO 2000/5 Gel in Men

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