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

NCT ID: NCT00002249

Last Updated: 2005-06-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Brief Summary

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

Detailed Description

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Conditions

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HIV Infections

Study Design

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Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Levofloxacin

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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R W Johnson Pharmaceutical Research Institute

INDUSTRY

Sponsor Role lead

Locations

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R W Johnson Pharmaceutical Research Institute

Raritan, New Jersey, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 8031049 (View on PubMed)

Other Identifiers

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K90-086

Identifier Type: -

Identifier Source: secondary_id

K90-024

Identifier Type: -

Identifier Source: secondary_id

105A/B

Identifier Type: -

Identifier Source: org_study_id