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

Sponsor:

Information provided by:

NIH AIDS Clinical Trials Information Service

Tracking Information

First Submitted Date ^ICMJE

November 2, 1999

First Posted Date ^ICMJE

August 31, 2001

Last Update Posted Date

June 24, 2005

Study Start Date ^ICMJE

Not Provided

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Not Provided

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

A Study of Ro 24-7429 in Patients With HIV-Related Kaposi's Sarcoma

Official Title ^ICMJE

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

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Masking: None (Open Label)
Primary Purpose: Treatment

Condition ^ICMJE

Sarcoma, Kaposi
HIV Infections

Intervention ^ICMJE

Drug: Ro 24-7429

Study Arms

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Not Provided

Original Enrollment ^ICMJE

Not Provided

Study Completion Date

Not Provided

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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.

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

United States

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT00002314

Other Study ID Numbers ^ICMJE

128A

Has Data Monitoring Committee

Not Provided

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Hoffmann-La Roche

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Not Provided

PRS Account

NIH AIDS Clinical Trials Information Service

Verification Date

December 1993

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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