A Double-Blind Study to Evaluate the Safety and Pharmacok... | NCT00002249

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

NCT00002249

Sponsor

R W Johnson Pharmaceutical Research Institute

Status

Completed

Last Update Posted

Jun 24, 2005Estimated

Enrollment

Not provided

Phase

Phase 1

Conditions

HIV Infections

Interventions

Levofloxacin

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 1991

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Not provided

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Nov 2, 1999

First Submission Date that Met QC Criteria

Aug 30, 2001

First Posted Date

Aug 31, 2001Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 23, 2005

Last Update Posted Date

Jun 24, 2005Estimated

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Name	Type	Description	Arm Group Labels	Other Names
Levofloxacin	Drug

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
R W Johnson Pharmaceutical Research Institute		Raritan	New Jersey	088690602	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
8031049	Background	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.

ID	Term
D015658	HIV Infections
D000163	Acquired Immunodeficiency Syndrome

ID	Term
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections
D015229	Sexually Transmitted Diseases, Viral

ID	Term
D015242	Ofloxacin
D024841	Fluoroquinolones
D042462	4-Quinolones
D015363	Quinolones

ID	Type	Description	Link
K90-086
K90-024