Search / Trial NCT00000753

A Phase I Concentration-Targeted Multidose Study of Atevirdine Mesylate ( U-87201E ), AZT, and ddI or ddC

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

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Trial Information

Current as of June 14, 2024

Completed

Keywords

Zalcitabine Didanosine Drug Therapy, Combination Acquired Immunodeficiency Syndrome Aids Related Complex Antiviral Agents Zidovudine

Description

Since the use of non-nucleoside reverse transcriptase inhibitors such as U-87201E has been associated with the rapid development of resistant HIV isolates, an initial evaluation of this drug in patients was made in combination with AZT. Because of the inability to detect resistance after 6 weeks of combined AZT/U-87201E therapy, this protocol will initially investigate U-87201E administered alone and then investigate the effect of this drug with AZT and ddI or ddC. Ten patients are treated at each of three targeted concentration ranges of U-87201E. Patients in the second cohort are enrolle...

Gender

All

Eligibility criteria

  • Inclusion Criteria
  • Concurrent Medication:
  • Allowed:
  • PCP prophylaxis with pentamidine, TMP/SMX, or dapsone (if appropriate).
  • Clotrimazole troches or nystatin oral suspension for oral candidiasis.
  • Acyclovir (up to 1000 mg/day) for herpes lesions.
  • Supportive care as deemed necessary for toxicities .
  • Patients must have:
  • HIV infection.
  • CD4 count <= 500 cells/mm3.
  • No active opportunistic infections.
  • Consent of parent, guardian, or person with power of attorney, if less than 18 years of age.
  • NOTE:
  • Participation of women in the study is encouraged.
  • Exclusion Criteria
  • Co-existing Condition:
  • Patients with the following symptoms and conditions are excluded:
  • Acute medical problems, including opportunistic infections (e.g., active cryptococcosis, Pneumocystis carinii, herpes zoster, histoplasmosis, and CMV) or nonopportunistic diseases (e.g., liver or renal disease or lymphoma).
  • Current diagnosis of malignancy for which systemic therapy would be required during the study.
  • Active gastrointestinal disorders.
  • Concurrent Medication:
  • Excluded:
  • Investigational drugs.
  • Systemic therapy for malignancy.
  • Phenobarbital, phenytoin, ketoconazole, rifampin, rifabutin, cimetidine, beta blockers, chronic antacids, antiarrhythmic agents, or other medications known to affect cardiac conduction or seizure threshold.
  • Patients with the following prior conditions are excluded:
  • History of any cardiovascular disease, including conduction disturbances, arrhythmias or atherosclerotic heart disease.
  • History of CNS disease such as seizure disorder, AIDS Dementia Complex, progressive multifocal leukoencephalopathy, or any other active neurological disorder.
  • History of chronic gastrointestinal disorders such as chronic diarrhea (> 4 weeks duration).
  • Prior Medication:
  • Excluded:
  • Antiretroviral or immunomodulator agents (such as AZT, ddI, ddC, interferon, etc.) within 15 days prior to study entry.
  • Cytotoxic chemotherapy within 1 month prior to study entry.
  • Prior U-87201E or other non-nucleoside reverse transcriptase inhibitors (i.e., nevirapine, TIBO, L697,661).
  • Present use of alcohol or illicit drugs.

Attachments

readout_NCT00000753_2024-06-14.pdf

4.5 MB

NCT00000753_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

Los Angeles, California, United States

Miami, Florida, United States

Saint Louis, Missouri, United States

Saint Louis, Missouri, United States

Rochester, New York, United States

Columbus, Ohio, 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

5 stars
41
4 stars
6
3 stars
2
2 stars
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1 stars
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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?

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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