Search / Trial NCT00001074

The Safety and Effectiveness of Hydroxyurea and ddI Used Individually or Together in HIV-Infected Patients

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

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Trial Information

Current as of March 02, 2024

Completed

Keywords

Didanosine Drug Therapy, Combination Antiviral Agents Hydroxyurea

Description

Current antiviral therapies for HIV-1 are limited by a few choices, and the lack of sustained clinical benefit from the drugs. The mechanisms that account for the lack of prolonged inhibition of viral replication by these agents are not fully understood. The activity of RT inhibitors might be potentiated by inhibiting host cellular enzymes essential for efficient HIV reverse transcription. Based on this information, comparisons of the antiviral effects of ddI monotherapy and hydroxyurea plus ddI, with the cellular enzyme ribonucleotide reductase as a potential target, should be done. This ...

Gender

All

Eligibility criteria

  • Inclusion Criteria
  • Concurrent Medication:
  • Allowed:
  • AS PER AMENDMENT 5/5/97:
  • PCP prophylaxis with trimethoprim/sulfamethoxazole or Dapsone.
  • Patients must have:
  • HIV-1 infection.
  • AS PER AMENDMENT 5/5/97:
  • CD4 count of 200 - 700 cells/mm3 within 60 days prior to study entry.
  • AS PER AMENDMENT 10/1/97:
  • HIV RNA plasma level < 20,000 copies/ml within 60 days of enrollment (obtained at a laboratory certified to perform the Roche Monitor assay).
  • Exclusion Criteria
  • Co-existing Condition:
  • Patients with any of the following symptoms or conditions are excluded:
  • CMV, MAC, toxoplasmosis, or disseminated fungal infection requiring acute or chronic therapy.
  • Significant medical illness as determined by investigator.
  • Active diagnosis of any malignancy, including visceral Kaposi's sarcoma or extensive cutaneous Kaposi's sarcoma for which systemic chemotherapy is anticipated within the next 24 weeks.
  • Current Grade 2 or greater peripheral neuropathy.
  • Concurrent Medication:
  • Excluded:
  • Acute or chronic therapy for CMV, MAC, toxoplasmosis, or disseminated fungal infection.
  • AS PER AMENDMENT 5/5/97:
  • All antiretroviral medications other than those provided on study.
  • Systemic chemotherapy for active malignancies, including systemic treatment for KS.
  • Agents with myelosuppressive potential, including tegretol, carboplatin, carmustine, cyclophosphamide and fluorouracil.
  • Granulocyte colony stimulating factor (G-CSF) except while hydroxyurea or matching placebo is held.
  • Drugs associated with peripheral neuropathy, including:
  • hydralazine, disulfiram, nitrofurantoin, cisplatinum, diethyldithiocarbamate, gold, rifampin, chloramphenicol, clioquinol, ethambutol, ethionamide, glutethimide, sodium cyanate, and thalidomide.
  • Patients with any of the prior conditions are excluded:
  • History of transfusion dependent anemia, defined as any history of repeated transfusion with two or more units of red blood cells.
  • At the discretion of the investigator, history of pancreatitis.
  • Prior Medication:
  • Excluded:
  • More than 2 weeks prior treatment with ddI.
  • AS PER AMENDMENT 5/5/97:
  • Other antiretrovirals must be discontinued at least 14 days prior to randomization.
  • Prior hydroxyurea.
  • Any candidate HIV vaccine or agent with potential immune modulating effects within the past 30 days.
  • Any colony stimulating factor or erythropoietin within the past 60 days.
  • Prior Treatment:
  • Excluded:
  • Transfusion with red blood cells within the past 60 days.
  • Risk Behavior:
  • Excluded:
  • At the investigator's discretion, any active substance abuse, including alcohol abuse interfering with compliance.

Attachments

readout_NCT00001074_2024-03-02.pdf

4.5 MB

NCT00001074_study_protocol.pdf

4.5 MB

About company

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

Jennifer Cobb

Immunology at National Institute of Allergy and Infectious Diseases (NIAID)

Locations

New York, New York, United States

New York, New York, United States

West Columbia, South Carolina, United States

Seattle, Washington, United States

San Diego, California, United States

New York, New York, United States

Chapel Hill, North Carolina, United States

Durham, North Carolina, United States

Cleveland, Ohio, United States

San Francisco, California, United States

Stanford, California, United States

Torrance, California, United States

Baltimore, Maryland, United States

Cincinnati, Ohio, United States

Cleveland, Ohio, United States

Philadelphia, Pennsylvania, United States

Philadelphia, Pennsylvania, United States

Denver, Colorado, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Reviews (48)

4.6

All reviews come from applied patients

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Leslie Alexander
20 September 2023

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Michael Foster
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Dries Vincent
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

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