search
Back to results

A Phase I/II Clinical Study of WF 10 IV Solution ( TCDO ) in Patients With HIV Infection

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 1
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, AIDS-Related Complex, Antiviral Agents

Eligibility Criteria

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

Inclusion Criteria Concurrent Medication: 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 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. 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.

Sites / Locations

  • Oncol Med Associates

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
June 23, 2005
Sponsor
Oxo Chemie GmbH
search

1. Study Identification

Unique Protocol Identification Number
NCT00002119
Brief Title
A Phase I/II Clinical Study of WF 10 IV Solution ( TCDO ) in Patients With HIV Infection
Official Title
A Phase I/II Clinical Study of WF 10 IV Solution ( TCDO ) in Patients With HIV Infection
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
To evaluate the clinical toxicity, safety, and MTD of WF 10 ( TCDO ) intravenous solution administered to patients with HIV infection. To evaluate the potential anti-HIV activity of TCDO.

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, AIDS-Related Complex, Antiviral Agents

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1

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: 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 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. 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.
Facility Information:
Facility Name
Oncol Med Associates
City
Houston
State/Province
Texas
ZIP/Postal Code
77074
Country
United States

12. IPD Sharing Statement

Citations:
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
background
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
background
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
background

Learn more about this trial

A Phase I/II Clinical Study of WF 10 IV Solution ( TCDO ) in Patients With HIV Infection

We'll reach out to this number within 24 hrs