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

This study has been completed.

Sponsor:

Information provided by:

NIH AIDS Clinical Trials Information Service

ClinicalTrials.gov Identifier:

NCT00002249

First received: November 2, 1999

Last updated: June 23, 2005

Last verified: September 1991

History of Changes

Purpose

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

Condition	Intervention	Phase
HIV Infections	Drug: Levofloxacin	Phase 1


Study Type:	Interventional
Study Design:	Masking: Double-Blind Primary Purpose: Treatment
Official Title:	A Double-Blind Study to Evaluate the Safety and Pharmacokinetics of L-Ofloxacin (RWJ 25213) in Subjects With HIV Infection

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS

Drug Information available for: Ofloxacin Levofloxacin Ofloxacin hydrochloride

U.S. FDA Resources

Further study details as provided by NIH AIDS Clinical Trials Information Service:

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	Male
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002249

Locations


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

Sponsors and Collaborators

R W Johnson Pharmaceutical Research Institute

More Information

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.


ClinicalTrials.gov Identifier:	NCT00002249 History of Changes
Other Study ID Numbers:	105A/B K90-086 K90-024
Study First Received:	November 2, 1999
Last Updated:	June 23, 2005

Keywords provided by NIH AIDS Clinical Trials Information Service:


Anti-Infective Agents, Quinolone Ofloxacin Acquired Immunodeficiency Syndrome

Additional relevant MeSH terms:


Infection Communicable Diseases HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases	Levofloxacin Ofloxacin Anti-Infective Agents, Urinary Anti-Infective Agents Renal Agents Anti-Bacterial Agents Topoisomerase II Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Cytochrome P-450 CYP1A2 Inhibitors Cytochrome P-450 Enzyme Inhibitors

ClinicalTrials.gov processed this record on July 28, 2017

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