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

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
WF10
Sponsored by
Oxo Chemie GmbH
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring Acquired Immunodeficiency Syndrome, Antiviral Agents

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Nashville Health Management Foundation / Vanderbilt Univ

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
June 23, 2005
Sponsor
Oxo Chemie GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT00002152
Brief Title
A Study of WF 10 IV Solution in Patients With Advanced HIV Disease
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 1996
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Oxo Chemie GmbH

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Acquired Immunodeficiency Syndrome, Antiviral Agents

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
Double
Enrollment
60 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
WF10

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Nashville Health Management Foundation / Vanderbilt Univ
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States

12. IPD Sharing Statement

Citations:
Citation
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)
Results Reference
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Citation
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)
Results Reference
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PubMed Identifier
9717676
Citation
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.
Results Reference
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A Study of WF 10 IV Solution in Patients With Advanced HIV Disease

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