A Study of Ro 24-7429 in Patients With HIV-Related Kaposi's Sarcoma
Information provided by (Responsible Party)
NIH AIDS Clinical Trials Information Service
First received: November 2, 1999
Last updated: June 23, 2005
Last Verified: December 1993
History of Changes
To study the effects of Ro 24-7429 on tumor growth in patients with HIV-related Kaposi's sarcoma. To study the safety and tolerance, effects on HIV replication, and immunologic effects of Ro 24-7429 in this patient population. To explore relationships between exposure to Ro 24-7429 and its metabolites with its antitumor and antiviral activities and drug toxicity.
Drug : Ro 24-7429
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||A Phase II Study of Oral Ro 24-7429 (Tat Antagonist) in Patients With HIV-Related Kaposi's Sarcoma|
Further study details as provided by NIH AIDS Clinical Trials Information Service:
|Ages Eligible for Study:||18 Years and older|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
Patients must have:
- HIV seropositivity.
- Biopsy-proven mucocutaneous Kaposi's sarcoma with fewer than 50 skin lesions and measurable disease.
- 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.
- Stable weight (+/- 2 kg) by 28 days prior to study entry.
- Other active malignancies (except basal cell carcinoma of the skin and in situ cervical cancer).
- Known or suspected hypersensitivity to benzodiazepines.
- Evidence of clinically significant cardiac, respiratory, hepatic, gastrointestinal, endocrine, hematologic, psychiatric, neurologic, dermatologic, or allergic disease as determined by the investigator.
- Ongoing diarrhea (> two liquid stools per day).
- Grade 2 or worse signs and symptoms of AIDS Dementia Complex.
- Alteration of mental status that may interfere with study compliance.
- AZT, ddI, or ddC.
- Experimental antiretrovirals.
- Biologic response modifiers or immunomodulating agents (e.g., interferon).
- Colony stimulating factors (erythropoietin, GM-CSF, G-CSF).
- H-2 antagonists (cimetidine, ranitidine, famotidine, nizatidine).
- Any other investigational compound.
- Ongoing systemic treatment with corticosteroids (other than replacement therapy for adrenal insufficiency or short-term therapy of no more than 28 days for bronchial asthma).
- Cytotoxic chemotherapy (systemic and local).
- Drugs known to cause systemic toxicity, if avoidable (e.g., myelosuppressive, hepatotoxic, nephrotoxic, or neurotoxic drugs).
- Paromomycin sulfate.
- Chronic suppressive therapy for CMV and/or MAI.
- Interferons or immune modulators within 4 weeks prior to study entry.
- Prior systemic cytotoxic chemotherapy (patients with CD4 counts >= 200 cells/mm3 only).
- Benzodiazepines within 14 days prior to study entry.
- Intralesional chemotherapy for Kaposi's sarcoma within 2 weeks prior to study entry.
- Therapy with antiretroviral drugs (including AZT, ddI, ddC, d4T) or investigational
Patients with the following symptoms or conditions are excluded:
Patients with the following prior condition are excluded:
History of serious adverse reactions to benzodiazepines.
Localized radiotherapy. Radiotherapy (other than localized). Active drug or alcohol abuse.
Contacts and LocationsChoosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002314
Locations Show More
|United States, California|
|CARE Ctr / UCLA Med Ctr|
|Los Angeles, California, United States, 900951793|
|United States, Massachusetts|
|New England Deaconess Hosp|
|Boston, Massachusetts, United States, 02215|
Sponsors and CollaboratorsHoffmann-La Roche
|Responsible Party:||Hoffmann-La Roche|
|ClinicalTrials.gov Identifier:||NCT00002314 History of Changes|
|Other Study ID Numbers:||128A|
|Study First Received:||November 2, 1999|
|Last Updated:||June 23, 2005|
Keywords provided by NIH AIDS Clinical Trials Information Service:Sarcoma, Kaposi
Acquired Immunodeficiency Syndrome
Gene Products, tat
Additional relevant MeSH terms:
ClinicalTrials.gov processed this data on October 17, 2017
This information is provided by ClinicalTrials.gov.