A Study to Evaluate the Safety and Effectiveness of WF10 Given to Patients With Late-Stage HIV Disease

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Pivotal Clinical Study Evaluating the Safety and Efficacy of WF10 (TCDO) Intravenous Solution in the Management of Patients With Late-Stage HIV Disease

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00002244

Enrollment

240

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

Placebos, Infusions, Intravenous, Quality of Life, Anti-HIV Agents, tetrachlorodecaoxide

Brief summary

The purpose of this study is to see if it is safe and effective to give WF10 to adults with late-stage HIV disease. WF10 is suspected to help the immune system fight infection and slow HIV disease progression.

Detailed description

Patients are randomized to 1 of 2 treatment groups to receive 4 IV treatment cycles of either WF10 or control (physiological saline solution). Patients are monitored throughout the study for: a) clinical progression; b) number, duration, and cause of hospitalizations; c) quality of life; and d) density of CD38 antigen on CD8+ T cells. Patients receive treatment for 11 weeks but will continue to be followed for a maximum of 96 weeks. During the follow-up period, patients are evaluated initially at Week 18, then at Weeks 24, 36, and 48. If the study is continued beyond Week 48, follow-up visits are conducted at Weeks 72 and 96.

Interventions

DRUGWF10

Study design

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Patients may be eligible for this study if they: * Are HIV-positive. * Have a CD4 cell count of less than 50 cells/mm3 within 14 days prior to study entry. * Are at least 18 years old. * Have received anti-HIV drugs at some time in the past. * Agree to practice abstinence or use effective methods of birth control, including the pill, during the study.

Exclusion criteria

Patients will not be eligible for this study if they: * Are being treated for any form of cancer within 30 days of study entry. * Have ever received an HIV vaccine. * Have received steroids within 30 days prior to study entry. (Note: Testosterone is allowed.) * Have received certain medications, including anti-HIV treatments that are not approved by the FDA. * Have participated in another WF10 study. * Have an illness or any condition that might exclude them from this study. * Are pregnant or breast-feeding. * Abuse drugs or medications. * Received a blood transfusion within 45 days prior to study entry.

Countries

Canada, United States

Outcome results

None listed

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