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| Descriptive Information Fields | |
| Brief Title † | A Study of Ro 24-7429 in Patients With HIV-Related Kaposi's Sarcoma |
| Official Title † | A Phase II Study of Oral Ro 24-7429 (Tat Antagonist) in Patients With HIV-Related Kaposi's Sarcoma |
| Brief Summary | 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. |
| Detailed Description | |
| Study Phase | Phase II |
| Study Type † | Interventional |
| Study Design † | Treatment, Open Label, Safety Study |
| Primary Outcome Measure † | |
| Secondary Outcome Measure † | |
| Condition † | Sarcoma, Kaposi HIV Infections |
| Intervention † | Drug: Ro 24-7429 |
| MEDLINE PMIDs | |
| Links | |
| Recruitment Information Fields | |
| Recruitment Status † | Completed |
| Enrollment † | |
| Start Date † | |
| Completion Date | |
| Eligibility Criteria † | 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. |
| Gender | Both |
| Ages | 18 Years and older |
| Accepts Healthy Volunteers | No |
| Contacts †† | |
| Location Countries † | United States |
| Administrative Information Fields | |
| NCT ID † | NCT00002314 |
| Organization ID | 128A |
| Secondary IDs †† | |
| Study Sponsor † | Hoffmann-La Roche |
| Collaborators †† | |
| Investigators † | |
| Information Provided By | NIH AIDS Clinical Trials Information Service |
| Verification Date | December 1993 |
| First Received Date † | November 2, 1999 |
| Last Updated Date | June 23, 2005 |