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Clinical Trials

MainTitle

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
R W Johnson Pharmaceutical Research Institute


Information provided by (Responsible Party)
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

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
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

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

Eligibility

Eligibility

Ages Eligible for Study: 18 Years and older  
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

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

More Information


Responsible Party: R W Johnson Pharmaceutical Research Institute  
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
Levofloxacin
Ofloxacin

ClinicalTrials.gov processed this data on October 20, 2017
This information is provided by ClinicalTrials.gov.