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A Phase II Study of Oral Ro 24-7429 (Tat Antagonist) in Patients With HIV-Related Kaposi's Sarcoma

Phase 2
18 Years
Not Enrolling
Sarcoma, Kaposi, HIV Infections

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Trial Information

A Phase II Study of Oral Ro 24-7429 (Tat Antagonist) in Patients With HIV-Related Kaposi's Sarcoma

Inclusion 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:


- 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

- 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:


- Interferons or immune modulators within 4 weeks prior to study entry.

- Prior systemic cytotoxic chemotherapy (patients with CD4 counts >= 200 cells/mm3

- 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.

Type of Study:


Study Design:

Endpoint Classification: Safety Study, Masking: Open Label, Primary Purpose: Treatment


United States: Food and Drug Administration

Study ID:




Start Date:

Completion Date:

Related Keywords:

  • Sarcoma, Kaposi
  • HIV Infections
  • Sarcoma, Kaposi
  • Acquired Immunodeficiency Syndrome
  • Antineoplastic Agents
  • Gene Products, tat
  • HIV Infections
  • Acquired Immunodeficiency Syndrome
  • Sarcoma, Kaposi
  • Sarcoma



New England Deaconess Hosp Boston, Massachusetts  02215
CARE Ctr / UCLA Med Ctr Los Angeles, California  900951793