Search / Trial NCT00000760

A Randomized Study of Activity, Safety, and Tolerance of Oral Ro 24-7429 (Tat Antagonist) in Patients With HIV Infection

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001

Trial Information

Current as of December 14, 2024

Completed

Keywords

Didanosine Acquired Immunodeficiency Syndrome Aids Related Complex Antiviral Agents Zidovudine Gene Products, Tat

ClinConnect Summary

The HIV genome contains a number of genes that regulate viral replication. Control of the activity of these genes and their encoded proteins represents a potential target for development of new antiretroviral drugs. The tat (transactivator of transcription of HIV) antagonist Ro 24-7429 is the first compound for clinical testing that utilizes this approach for therapy of HIV infection.

Ninety-six patients (four treatment arms of 24 patients each) are randomized to receive oral Ro 24-7429 at 1 of 3 doses or nucleoside control (either zidovudine or didanosine). The study will be blinded only ...

Gender

ALL

Eligibility criteria

  • Inclusion Criteria
  • Concurrent Medication:
  • Allowed:
  • Chemoprophylaxis for P. carinii pneumonia, TB, and mucocutaneous candidiasis.
  • Methadone maintenance.
  • Hormonal contraceptives.
  • Patients must have:
  • HIV-1 seropositivity.
  • CD4 count 50 - 500 cells/mm3.
  • Life expectancy of at least 24 weeks.
  • Stable weight (+/- 2 kg) by 28 days prior to study entry (by history).
  • NOTE:
  • At least 50 percent of patients must be p24 antigen positive (\>= 50 pg/ml).
  • Exclusion Criteria
  • Co-existing Condition:
  • Patients with the following symptoms and conditions are excluded:
  • Known or suspected hypersensitivity to benzodiazepines.
  • Presence of any malignancy other than basal cell carcinoma or limited cutaneous Kaposi's sarcoma (defined as no more than five lesions with no mucosal involvement).
  • Ongoing diarrhea, defined as more than 2 liquid stools per day.
  • History, physical exam, or laboratory results consistent with a subclinical AIDS-defining opportunistic infection.
  • Grade 2 or greater signs and symptoms of AIDS Dementia Complex.
  • Evidence of clinically significant cardiac, respiratory, hepatic, gastrointestinal, endocrine, hematologic, psychiatric, neurologic, dermatologic, or allergic disease.
  • Concurrent Medication:
  • Excluded:
  • Chronic suppressive therapy for CMV, MAI, toxoplasmosis, cryptococcosis, cryptosporidiosis, coccidioidomycosis, and histoplasmosis.
  • ddC, ddI, AZT (except for control groups) or other experimental antiretrovirals or immunomodulating agents.
  • Other medications excluded from the study.
  • Patients with the following prior conditions are excluded:
  • History of serious adverse reactions to benzodiazepines.
  • History of intolerance to AZT at 600 mg/day or less or ddI at 400 mg/day or less.
  • History of unexplained fever, defined as a temperature of 38.5 deg C or greater with or without night sweats for more than 7 of the past 28 days.
  • Prior Medication:
  • Excluded:
  • Benzodiazepines within 14 days prior to study entry.
  • Active drug or alcohol abuse that would interfere with study compliance.

Trial Officials

Richman DD

Study Chair

Haubrich R

Study Chair

About National Institute Of Allergy And Infectious Diseases (Niaid)

The National Institute of Allergy and Infectious Diseases (NIAID) is a key component of the National Institutes of Health (NIH) dedicated to advancing the understanding, prevention, and treatment of infectious and immune-mediated diseases. Through rigorous clinical trials, NIAID aims to foster innovative research that enhances public health and addresses global health challenges, including emerging infectious diseases and allergies. The institute collaborates with various partners, including academic institutions, industry, and international organizations, to translate scientific discoveries into effective therapies and vaccines. NIAID's commitment to high-quality clinical research is integral to improving health outcomes and informing policy decisions in the realm of infectious diseases and immunology.

Locations

San Diego, California, United States

Cleveland, Ohio, United States

Baltimore, Maryland, United States

Boston, Massachusetts, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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