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

Condition	Treatment or Intervention	Phase
HIV Infections	Drug: Levofloxacin	Phase I

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  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.

New Jersey
      R W Johnson Pharmaceutical Research Institute, Raritan,  New Jersey,  088690602,  United States

Study ID Numbers:  105A/B; K90-086; K90-024
Record last reviewed:  September 1991
Last Updated:  October 13, 2004
Record first received:  November 2, 1999
ClinicalTrials.gov Identifier:  NCT00002249
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08