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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00002152

Enrollment

Registered

2001-08-31

Start date

Unknown

Completion date

Unknown

Last updated

2005-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections

Keywords

Acquired Immunodeficiency Syndrome, Antiviral Agents

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.

Interventions

DRUGWF10

Study design

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026