Completed
Ro 24-7429 Effects on HIV-Related Kaposi's Sarcoma Tumor Growth and HIV Replication
What is being tested
Ro 24-7429
Drug
Who is being recruted
Blood-Borne Infections+21
+ Urogenital Diseases
+ Genital Diseases
Over 18 Years
+33 Eligibility Criteria
How is the trial designed
Treatment Study
Phase 2
Interventional
Summary
Principal SponsorHoffmann-La Roche
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner
This study focuses on a drug called Ro 24-7429 and its effects on patients with HIV-related Kaposi's sarcoma, a type of cancer that can develop in people with HIV. The main goal is to understand how this drug impacts the growth of the tumor. Additionally, the study aims to see how well patients can tolerate the drug and how it might affect HIV replication. The potential outcomes of this study could lead to improved treatment options for patients dealing with both HIV and Kaposi's sarcoma.
Principal SponsorHoffmann-La Roche
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 DiseasesDNA Virus InfectionsHerpesviridae InfectionsImmunologic Deficiency SyndromesImmune System DiseasesInfectionsNeoplasmsNeoplasms by Histologic TypeNeoplasms, Vascular TissueRetroviridae InfectionsRNA Virus InfectionsSarcomaSexually Transmitted DiseasesSlow Virus DiseasesVirus DiseasesSexually Transmitted Diseases, ViralLentivirus InfectionsNeoplasms, Connective and Soft TissueAcquired Immunodeficiency SyndromeSarcoma, KaposiHIV Infections
Criteria
5 inclusion criteria required to participate
No active opportunistic infection. NOTE: Patients with CD4 count >= 200 cells/mm3 must have no prior opportunistic infection, as well as no active opportunistic infection.
Life expectancy of at least 24 weeks.
Biopsy-proven mucocutaneous Kaposi's sarcoma with fewer than 50 skin lesions and measurable disease.
Stable weight (+/- 2 kg) by 28 days prior to study entry.
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28 exclusion criteria prevent from participating
Drugs known to cause systemic toxicity, if avoidable (e.g., myelosuppressive, hepatotoxic, nephrotoxic, or neurotoxic drugs).
Foscarnet.
AZT, ddI, or ddC.
Biologic response modifiers or immunomodulating agents (e.g., interferon).
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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 2 locations
New England Deaconess Hosp
Boston, United StatesCompleted2 Study Centers