Status:

COMPLETED

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

Lead Sponsor:

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborating Sponsors:

Upjohn

Glaxo Wellcome

Conditions:

HIV Infections

Eligibility:

All Genders

13+ years

Phase:

PHASE1

Brief Summary

To determine the safety, toxicity, pharmacokinetic profile, and antiretroviral activity of atevirdine mesylate ( U-87201E ) in HIV-infected patients. Per 06/04/93 amendment, to also evaluate the inter...

Detailed 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 patien...

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.

Key Trial Info

Start Date :

Trial Type :

INTERVENTIONAL

End Date :

February 1 1995

Estimated Enrollment :

30 Patients enrolled

Trial Details

Trial ID

NCT00000753

End Date

February 1 1995

Last Update

November 4 2021

Active Locations (6)

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Page 1 of 2 (6 locations)

1

USC CRS

Los Angeles, California, United States, 90033

2

Univ. of Miami AIDS CRS

Miami, Florida, United States, 33136

3

St. Louis ConnectCare, Infectious Diseases Clinic

St Louis, Missouri, United States, 63112

4

Washington U CRS

St Louis, Missouri, United States