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

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002314
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: December 1993
  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 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Masking: 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

Resource links provided by NLM:


Further study details as provided by NIH AIDS Clinical Trials Information Service:

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002314

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
Sponsors and Collaborators
Hoffmann-La Roche
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00002314     History of Changes
Other Study ID Numbers: 128A
Study First Received: November 2, 1999
Last Updated: June 23, 2005
Health Authority: United States: Food and Drug Administration

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
Acquired Immunodeficiency Syndrome
Sarcoma, Kaposi
Sarcoma
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Herpesviridae Infections
DNA Virus Infections
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Vascular Tissue
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 23, 2014