A Study of WF 10 IV Solution in Patients With Advanced HIV Disease
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Purpose
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 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety Study Masking: Double-Blind Primary Purpose: Treatment |
| 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 |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
More Information
Publications:
| ClinicalTrials.gov Identifier: | NCT00002152 History of Changes |
| Other Study ID Numbers: | 222B, WF10-94-US-002 |
| Study First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by NIH AIDS Clinical Trials Information Service:
|
Acquired Immunodeficiency Syndrome Antiviral Agents |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases |
Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases |
ClinicalTrials.gov processed this record on May 16, 2013