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

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Levofloxacin
Sponsored by
R W Johnson Pharmaceutical Research Institute
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring Anti-Infective Agents, Quinolone, Ofloxacin, Acquired Immunodeficiency Syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

  • R W Johnson Pharmaceutical Research Institute

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
June 23, 2005
Sponsor
R W Johnson Pharmaceutical Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT00002249
Brief Title
A Double-Blind Study to Evaluate the Safety and Pharmacokinetics of L-Ofloxacin (RWJ 25213) in Subjects With HIV Infection
Official Title
A Double-Blind Study to Evaluate the Safety and Pharmacokinetics of L-Ofloxacin (RWJ 25213) in Subjects With HIV Infection
Study Type
Interventional

2. Study Status

Record Verification Date
September 1991
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
R W Johnson Pharmaceutical Research Institute

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Anti-Infective Agents, Quinolone, Ofloxacin, Acquired Immunodeficiency Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Masking
Double

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Levofloxacin

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
R W Johnson Pharmaceutical Research Institute
City
Raritan
State/Province
New Jersey
ZIP/Postal Code
088690602
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
8031049
Citation
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. doi: 10.1128/AAC.38.4.799.
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A Double-Blind Study to Evaluate the Safety and Pharmacokinetics of L-Ofloxacin (RWJ 25213) in Subjects With HIV Infection

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