A Double-Blind Study to Evaluate the Safety and Pharmacokinetics of L-Ofloxacin (RWJ 25213) in Subjects With HIV Infection

Completed · Phase 1

Conditions studied: HIV Infections

In brief

To determine the safety and pharmacokinetics of L-ofloxacin (RWJ 25213) in patients with HIV infection.

Key facts

Study ID

NCT00002249

Run by

R W Johnson Pharmaceutical Research Institute

Last updated by the study team

2005-06-24

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Patients must have the following:
• HIV infection.

You may not qualify if…

• 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.

Where it is running

• R W Johnson Pharmaceutical Research Institute — Raritan, New Jersey, United States

Full record on ClinicalTrials.gov

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