A Study of Ro 24-7429 in Patients With HIV-Related Kaposi's Sarcoma
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ClinicalTrials.gov Identifier: NCT00002314 |
Recruitment Status
:
Completed
First Posted
: August 31, 2001
Last Update Posted
: June 24, 2005
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Sarcoma, Kaposi HIV Infections | Drug: Ro 24-7429 | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
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 |

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
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.
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
- 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.
Concurrent Medication:
Excluded:
- AZT, ddI, or ddC.
- Experimental antiretrovirals.
- Biologic response modifiers or immunomodulating agents (e.g., interferon).
- Colony stimulating factors (erythropoietin, GM-CSF, G-CSF).
- Ganciclovir.
- Foscarnet.
- H-2 antagonists (cimetidine, ranitidine, famotidine, nizatidine).
- Omeprazole.
- Benzodiazepines.
- 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.
Patients with the following prior condition are excluded:
History of serious adverse reactions to benzodiazepines.
Prior Medication:
Excluded:
- 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 drugs within 14 days prior to study entry.
Localized radiotherapy. Radiotherapy (other than localized). Active drug or alcohol abuse.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002314
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 |
ClinicalTrials.gov Identifier: | NCT00002314 History of Changes |
Other Study ID Numbers: |
128A |
First Posted: | August 31, 2001 Key Record Dates |
Last Update Posted: | June 24, 2005 |
Last Verified: | December 1993 |
Keywords provided by NIH AIDS Clinical Trials Information Service:
Sarcoma, Kaposi Acquired Immunodeficiency Syndrome Antineoplastic Agents Gene Products, tat |
Additional relevant MeSH terms:
HIV Infections Sarcoma Sarcoma, Kaposi Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases |
Immunologic Deficiency Syndromes Immune System Diseases Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Neoplasms Herpesviridae Infections DNA Virus Infections Neoplasms, Vascular Tissue |