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

Tracking Information
First Received Date ^ICMJE	November 2, 1999
Last Updated Date	June 23, 2005
Start Date ^ICMJE
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00002249 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	A Double-Blind Study to Evaluate the Safety and Pharmacokinetics of L-Ofloxacin (RWJ 25213) in Subjects With HIV Infection
Official Title ^ICMJE	A Double-Blind Study to Evaluate the Safety and Pharmacokinetics of L-Ofloxacin (RWJ 25213) in Subjects With HIV Infection
Brief Summary	To determine the safety and pharmacokinetics of L-ofloxacin (RWJ 25213) in patients with HIV infection.
Detailed Description
Study Phase	Phase I
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Double-Blind, Pharmacokinetics Study
Condition ^ICMJE	HIV Infections
Intervention ^ICMJE	Drug: Levofloxacin
Study Arms / Comparison Groups
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.
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE
Completion Date
Primary Completion Date
Eligibility Criteria ^ICMJE	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.
Gender	Male
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00002249
Responsible Party
Study ID Numbers ^ICMJE	105A/B, K90-086, K90-024
Study Sponsor ^ICMJE	R W Johnson Pharmaceutical Research Institute
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	NIH AIDS Clinical Trials Information Service
Verification Date	September 1991
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP