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



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

For Condition: HIV Infections
Status: Completed
Sponsor(s): Oxo Chemie GmbH ,
Synopsis: 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.
Details:
Eligibility:
Study Type:
  Interventional, Treatment, Dose Comparison, Safety Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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.
Total Enrollment: 

Location and Contact Information:

Oncol Med Associates
Houston,  Texas,  77074
United States
 


Additional Information:
Study ID Numbers:
  222A;  WF10-92-US-001
Study Start Date: 
Record last reviewed: March 1996
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002119

Other Hiv Infections Studies:
1. T-20 in HIV Patients with Prior Drug Treatment and/or Resistance to Each of the Three Classes of Anti-HIV Drugs

2. The Healthy Life Choices Project in HIV-Positive Patients

3. A Phase I Study of the Safety and Pharmacokinetics of Recombinant CD4 (rCD4) in Patients With AIDS and AIDS-Related Complex

4. Endothelial Dysfunction as a Risk Factor in HIV Study

5. Phase I Study of Weekly Oral VP-16 for AIDS-Associated Kaposi's Sarcoma

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

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