Completed

WF 10 IV Solution (TCDO) Safety and Anti-HIV Activity in HIV Patients

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What is being tested

WF10

Drug
Who is being recruted

Blood-Borne Infections+14

+ Urogenital Diseases

+ Genital Diseases

Over 18 Years
+17 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1
Interventional
See protocol details

Summary

Principal SponsorOxo Chemie GmbH
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

This clinical study focuses on a drug called WF 10, also known as TCDO, and its use in patients diagnosed with HIV infection. The main goal is to understand the safety and any potential side effects of this drug when given intravenously. Additionally, the study aims to identify the maximum tolerable dose (MTD) of TCDO for these patients. The importance of this study lies in its potential to discover a new treatment option for HIV, contributing to the ongoing fight against this virus and improving patient care. During the study, participants with HIV infection receive the TCDO drug through an intravenous (IV) solution. The study measures the results by evaluating the clinical toxicity and safety of the drug, helping to understand how well the treatment is tolerated. Furthermore, the potential anti-HIV activity of TCDO is assessed, which could provide insights into its effectiveness against the virus.

NCT00002119
Principal SponsorOxo Chemie GmbH
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Blood-Borne InfectionsUrogenital DiseasesGenital DiseasesCommunicable DiseasesImmunologic Deficiency SyndromesImmune System DiseasesInfectionsRetroviridae InfectionsRNA Virus InfectionsSexually Transmitted DiseasesSlow Virus DiseasesVirus DiseasesSexually Transmitted Diseases, ViralLentivirus InfectionsAcquired Immunodeficiency SyndromeAIDS-Related ComplexHIV Infections

Criteria

7 inclusion criteria required to participate
Absolute CD4 count of 150 - 500 cells/mm3
Aerosolized pentamidine (300 mg monthly) as prophylaxis for PCP only in patients with CD4 count <= 200 cells/mm3
At least 6 months of prior zidovudine therapy
HIV positivity
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10 exclusion criteria prevent from participating
Abnormal neurological status by a standardized assessment including strength, reflex testing, and sensory testing
Active drug or alcohol abuse
Antiretroviral agent or interferon within 2 weeks prior to study entry
Clinically significant cardiac disease
Show More Criteria

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Oncol Med Associates

Houston, United StatesOpen Oncol Med Associates in Google Maps
CompletedOne Study Center