Completed

Daunorubicin vs ABV Chemotherapy in HIV-Associated Kaposi's Sarcoma Treatment

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What is being tested

Daunorubicin (liposomal)

+ Bleomycin sulfate

+ Vincristine sulfate

Drug
Who is being recruted

Blood-Borne Infections+21

+ Urogenital Diseases

+ Genital Diseases

Over 18 Years
+16 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 3
Interventional
See protocol details

Summary

Principal SponsorNexstar Pharmaceuticals
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

This study focuses on treating HIV-associated Kaposi's Sarcoma, a type of cancer that can develop in people with HIV. The research aims to compare the safety and effectiveness of two different treatment options: Daunoxome (daunorubicin liposomal) and a combination chemotherapy known as ABV (Adriamycin/Bleomycin/Vincristine). Both treatments will be used alongside antiretroviral therapy, a standard treatment for HIV. The goal is to understand which treatment option works better and causes fewer side effects, potentially improving care for individuals with this condition. During the study, participants will receive either Daunoxome or ABV, in addition to their regular antiretroviral therapy. The researchers will monitor the severity and time of onset of any side effects from the start of therapy. They will also compare how long the responses to treatment last, the rate of responses, and the time it takes for responses to occur. This will help them understand the benefits and risks of each treatment approach.

Principal SponsorNexstar Pharmaceuticals
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

3 inclusion criteria required to participate
Advanced Kaposi's sarcoma

HIV infection

Prior intralesional vinblastine allowed

13 exclusion criteria prevent from participating
Acute intercurrent infection other than genital herpes

Any condition that compromises ability to give informed consent or complete the study

Concurrent ganciclovir

Growth factors (G-CSF or GM-CSF), immune modifiers, or investigational agents within 14 days prior to study entry

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 13 locations

Univ of Arizona / Arizona Cancer Ctr

Tucson, United StatesOpen Univ of Arizona / Arizona Cancer Ctr in Google Maps

Kenneth Norris Jr Cancer Hosp

Los Angeles, United States

Desert Hosp Comprehensive Cancer Ctr

Palm Springs, United States

Saint Francis Mem Hosp

San Francisco, United States
Completed13 Study Centers