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Sponsors and Collaborators: |
National Institute of Allergy and Infectious Diseases (NIAID) Hoffmann-La Roche |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00000760 |
To study the anti-HIV activity of the various doses of Ro 24-7429 monotherapy based on virologic and immunologic endpoints. To study the safety and tolerance of Ro 24-7429. To explore relationships between exposure to Ro 24-7429 and its metabolites and antiviral activity and drug toxicity. To determine a safe, tolerable, and active dose regimen of Ro 24-7429, and to make preliminary observations of Ro 24-7429 in combination with another antiretroviral nucleoside.
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.
Condition | Intervention | Phase |
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HIV Infections |
Drug: Ro 24-7429 Drug: Zidovudine Drug: Didanosine |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Safety Study |
Official Title: | A Randomized Study of Activity, Safety, and Tolerance of Oral Ro 24-7429 (Tat Antagonist) in Patients With HIV Infection |
Estimated Enrollment: | 96 |
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 for the arms receiving Ro 24-7429. Treatment continues for 12 weeks. After 12 weeks, patients on the nucleoside control arm receive the highest tolerated dose of Ro 24-7429 in addition to their nucleoside.
Ages Eligible for Study: | 12 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
Allowed:
Patients must have:
NOTE:
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms and conditions are excluded:
Concurrent Medication:
Excluded:
Patients with the following prior conditions are excluded:
Prior Medication:
Excluded:
Active drug or alcohol abuse that would interfere with study compliance.
United States, California | |
UCSD | |
San Diego, California, United States, 92103 | |
United States, Maryland | |
Johns Hopkins Hosp | |
Baltimore, Maryland, United States, 21205 | |
United States, Massachusetts | |
Harvard (Massachusetts Gen Hosp) | |
Boston, Massachusetts, United States, 02114 | |
United States, Ohio | |
Case Western Reserve Univ | |
Cleveland, Ohio, United States, 44106 |
Study Chair: | Richman DD | |
Study Chair: | Haubrich R |
Study ID Numbers: | ACTG 213, NV14224A |
Study First Received: | November 2, 1999 |
Last Updated: | July 31, 2008 |
ClinicalTrials.gov Identifier: | NCT00000760 |
Health Authority: | United States: Federal Government |
Didanosine Acquired Immunodeficiency Syndrome AIDS-Related Complex |
Antiviral Agents Zidovudine Gene Products, tat |
Virus Diseases Sexually Transmitted Diseases, Viral Didanosine HIV Infections Sexually Transmitted Diseases |
Acquired Immunodeficiency Syndrome Zidovudine AIDS-Related Complex Retroviridae Infections Immunologic Deficiency Syndromes |
Antimetabolites Anti-Infective Agents Communicable Diseases RNA Virus Infections Anti-HIV Agents Slow Virus Diseases Immune System Diseases Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors |
Infection Antiviral Agents Pharmacologic Actions Reverse Transcriptase Inhibitors Anti-Retroviral Agents Therapeutic Uses Lentivirus Infections Nucleic Acid Synthesis Inhibitors |