The Safety and Effectiveness of Ritonavir in the Treatment of HIV-Related Kaposi's Sarcoma
This study has been completed.
Sponsor:
Abbott
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT00002366
First received: November 2, 1999
Last updated: February 19, 2009
Last verified: February 2009
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![](https://webarchive.library.unt.edu/web/20130225131305im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
To evaluate the safety and anti-Kaposi's sarcoma activity of ritonavir.
Condition | Intervention | Phase |
---|---|---|
Sarcoma, Kaposi HIV Infections |
Drug: Ritonavir |
Phase 2 |
Study Type: | Interventional |
Study Design: | Endpoint Classification: Safety Study Primary Purpose: Treatment |
Official Title: | A Phase II Safety and Activity Study of Ritonavir in the Treatment of HIV-Associated Cutaneous Kaposi's Sarcoma |
Resource links provided by NLM:
Genetics Home Reference related topics:
complement factor I deficiency
Drug Information available for:
Ritonavir
U.S. FDA Resources
Further study details as provided by Abbott:
![](https://webarchive.library.unt.edu/web/20130225131305im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria
Concurrent Medication:
Allowed:
- Patients may receive oral acyclovir and may continue prophylactic treatment for PCP, fungal infection, MAC and toxoplasmosis.
- Topical treatment and intralesional chemotherapy will be allowed for lesions which will not be used as indicator or biopsy lesions.
Concurrent Treatment:
Allowed:
Localized radiotherapy will be allowed for lesions which will not be used as indicator or biopsy lesions.
Patients must have:
- Documentation of a positive ELISA test for HIV with a confirmatory test.
- Biopsy proven, cutaneous or oropharyngeal Kaposi's sarcoma.
- Vital signs, physical examination and laboratory assessments that exhibit no evidence of an acute illness.
- Patients must agree to report all current medications to the primary investigator and obtain prior permission to use them when feasible.
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms and conditions are excluded:
- Evidence of pulmonary Kaposi's sarcoma.
- Positive urine screen for recreational drugs.
- Current participation in another antiviral research study.
- Investigator anticipates poor patient compliance with the protocol.
- Patient has any condition that, in the investigator's opinion, may obscure the proper observation of the safety or activity of ritonavir.
Concurrent Medication:
Excluded:
- Antiretroviral therapy.
- Protease inhibitor therapy.
- Antiviral agent (e.g., oral ganciclovir or Foscarnet) or prophylactic medication for an AIDS defining illness which the patient cannot be removed from.
- Chemotherapy for Kaposi's sarcoma.
- Treatment with any medications that may interact with ritonavir.
Concurrent Treatment:
Excluded:
Radiotherapy for Kaposi's sarcoma.
Patients with any of the following prior conditions are excluded:
- History of psychiatric illness which is currently medically significant.
- History of pancreatitis.
Prior Medication:
Excluded:
- All antiretroviral therapy within 2 weeks prior to the start of the treatment phase of the study.
- Systemic chemotherapy of interferon within 30 days prior to study entry.
- Previous treatment with a protease inhibitor.
Risk Behavior:
Excluded:
Active substance abuse.
![](https://webarchive.library.unt.edu/web/20130225131305im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
![](https://webarchive.library.unt.edu/web/20130225131305im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
Publications:
Carr A, Milliken S, Lewis C, Mitsuyasu R, Miles S, Newell M, Cooper DA. A pilot phase II safety and activity study of ritonavir in the treatment of HIV-associated cutaneous Kaposi's sarcoma. Conf Retroviruses Opportunistic Infect. 1997 Jan 22-26;4th:194 (abstract no 703)
ClinicalTrials.gov Identifier: | NCT00002366 History of Changes |
Other Study ID Numbers: | 245C, M95-320 |
Study First Received: | November 2, 1999 |
Last Updated: | February 19, 2009 |
Health Authority: | United States: Food and Drug Administration |
Keywords provided by Abbott:
Skin Neoplasms Sarcoma, Kaposi Acquired Immunodeficiency Syndrome HIV Protease Inhibitors Ritonavir |
Additional relevant MeSH terms:
HIV Infections Acquired Immunodeficiency Syndrome Sarcoma, Kaposi Sarcoma Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Herpesviridae Infections DNA Virus Infections |
Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Neoplasms Neoplasms, Vascular Tissue HIV Protease Inhibitors Ritonavir Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on February 21, 2013