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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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