The Safety and Effectiveness of 935U83 in HIV-Infected Patients
A Phase I Trial to Evaluate the Safety, Tolerance, and Pharmacokinetics of 935U83 After Multiple Dosing in Patients With HIV Infection
2 other identifiers
interventional
40
1 country
7
Brief Summary
To assess the safety, tolerance, and steady-state pharmacokinetics of multiple oral doses of 935U83 administered to patients with HIV infection. To obtain preliminary evidence of antiretroviral activity of 935U83. To prospectively evaluate the emergence of in vitro drug resistance. To determine the effects of 935U83 dosing on CD4+ cell counts.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 hiv-infections
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedJune 24, 2005
April 1, 1996
November 2, 1999
June 23, 2005
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- Concurrent Medication:
- Recommended:
- PCP prophylaxis for patients whose CD4 counts fall below 200 cells/mm3 or who develop PCP during study participation.
- Allowed:
- Acute treatment and secondary prophylaxis for tuberculosis, Mycobacterium avium intracellulare, toxoplasmosis, histoplasmosis, cryptococcosis, disseminated candidiasis, or cytomegalovirus infection.
- Patients must have:
- HIV infection.
- CD4 count 200 - 500 cells/mm3.
- No history of or current AIDS-defining indicator disease by CDC criteria.
- No antiretroviral therapy within the past 6 months.
- Consent of parent or guardian if less than 18 years of age.
You may not qualify if:
- Co-existing Condition:
- Patient with the following symptoms or conditions are excluded:
- Current evidence of chronic hepatitis of any etiology.
- Seropositivity for HBsAg or hepatitis C virus by second generation ELISA.
- Concurrent Medication:
- Excluded:
- Cytotoxic chemotherapy.
- Other antiretroviral drugs.
- Immunomodulators.
- Foscarnet.
- GM-CSF or G-CSF.
- Erythropoietin.
- Concurrent Treatment:
- Excluded:
- Radiation therapy.
- +12 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Glaxo Wellcomelead
Study Sites (7)
ViRx Inc
San Francisco, California, 94103, United States
Georgetown Univ Med Ctr
Washington D.C., District of Columbia, 20007, United States
Goodgame Med Group
Maitland, Florida, 32751, United States
Indiana Univ Hosp
Indianapolis, Indiana, 46202, United States
Duke Univ Med Ctr
Durham, North Carolina, 27710, United States
Univ of Cincinnati / Holmes Hosp
Cincinnati, Ohio, 45267, United States
Univ of Pittsburgh Med School
Pittsburgh, Pennsylvania, 15261, United States
Related Publications (1)
Riddler SA, Wang LH, Bartlett JA, Savina PM, Packard MV, McMahon DK, Blum MR, Dunn JA, Elkins MM, Mellors JW. Safety and pharmacokinetics of 5-chloro-2',3'-dideoxy-3'-fluorouridine (935U83) following oral administration of escalating single doses in human immunodeficiency virus-infected adults. Antimicrob Agents Chemother. 1996 Dec;40(12):2842-7. doi: 10.1128/AAC.40.12.2842.
PMID: 9124852BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Purpose
- TREATMENT
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 2, 1999
First Posted
August 31, 2001
Last Updated
June 24, 2005
Record last verified: 1996-04