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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
ClinicalTrials.gov processed this data on August 23, 2015
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: Endpoint Classification: Pharmacokinetics Study, Masking: Double-Blind, Primary Purpose: Treatment

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

Page last updated: August 23, 2015

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