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| Sponsor: | Hoffmann-La Roche |
|---|---|
| Information provided by: | NIH AIDS Clinical Trials Information Service |
| ClinicalTrials.gov Identifier: | NCT00002314 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Sarcoma, Kaposi HIV Infections |
Drug: Ro 24-7429 |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label, Safety Study |
| Official Title: | A Phase II Study of Oral Ro 24-7429 (Tat Antagonist) in Patients With HIV-Related Kaposi's Sarcoma |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Patients must have:
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
Concurrent Medication:
Excluded:
Patients with the following prior condition are excluded:
History of serious adverse reactions to benzodiazepines.
Prior Medication:
Excluded:
Localized radiotherapy. Radiotherapy (other than localized). Active drug or alcohol abuse.
Contacts and Locations| 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 | |
More Information
| Study ID Numbers: | 128A |
| Study First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00002314 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Sarcoma, Kaposi Acquired Immunodeficiency Syndrome Antineoplastic Agents Gene Products, tat |
|
RNA Virus Infections Sexually Transmitted Diseases, Viral Neoplasms by Histologic Type Slow Virus Diseases Immune System Diseases Acquired Immunodeficiency Syndrome Sarcoma, Kaposi Infection Immunologic Deficiency Syndromes Herpesviridae Infections |
Virus Diseases Neoplasms, Connective and Soft Tissue Neoplasms HIV Infections Sexually Transmitted Diseases Neoplasms, Vascular Tissue Sarcoma Lentivirus Infections DNA Virus Infections Retroviridae Infections |