A Double-Blind Study to Evaluate the Safety and Pharmacokinetics of L-Ofloxacin (RWJ 25213) in Subjects With HIV Infection
Information source: NIH AIDS Clinical Trials Information Service
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: HIV Infections
Intervention: Levofloxacin (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: R W Johnson Pharmaceutical Research Institute
Summary
To determine the safety and pharmacokinetics of L-ofloxacin (RWJ 25213) in patients with HIV
infection.
Clinical Details
Official title: A Double-Blind Study to Evaluate the Safety and Pharmacokinetics of L-Ofloxacin (RWJ 25213) in Subjects With HIV Infection
Study design: Treatment, Double-Blind, Pharmacokinetics Study
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Male.
Criteria:
Inclusion Criteria
Patients must have the following:
HIV infection.
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
- Active opportunistic infection or neoplasm.
- High likelihood of death during study.
- Significant ophthalmologic, renal, hepatic, cardiovascular, hematologic, neurologic,
psychiatric,respiratory, or metabolic disease.
- Donation of > 1 unit blood or acute loss of blood within one month of study entry.
Patients with the following prior conditions are excluded:
- History of opportunistic infection.
- Previous allergic reaction to ciprofloxacin, norfloxacin, or any other quinolone.
Prior Medication:
Excluded:
Use of any investigational agent within 7 days of entry into study. Use of any medication
within 3 days prior to entry (7 days for AZT). Alcohol or drug abuse.
Locations and Contacts
R W Johnson Pharmaceutical Research Institute, Raritan, New Jersey 088690602, United States
Additional Information
Related publications: Goodwin SD, Gallis HA, Chow AT, Wong FA, Flor SC, Bartlett JA. Pharmacokinetics and safety of levofloxacin in patients with human immunodeficiency virus infection. Antimicrob Agents Chemother. 1994 Apr;38(4):799-804.
Last updated: June 23, 2005
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