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An Ascending, Single Oral Dose Pharmacokinetic Study of 3'-Deoxy-3'-Fluorothymidine (FLT) in Asymptomatic Human Immunodeficiency Virus (HIV)-Infected Subjects

Primary Purpose

HIV Infections

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Alovudine
Sponsored by
Lederle Laboratories
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring Thymidine, Nucleosides, Antiviral Agents

Eligibility Criteria

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

Exclusion Criteria Co-existing Condition: Patients with the following conditions or symptoms are excluded: Oral candida infection documented by morphology or by response to antifungal therapy within 2 months prior to study entry. Temperature > 37.8 degrees Centigrade. Malignancy other than cutaneous basal cell carcinoma or cervical carcinoma in situ. Significant chronic underlying medical illnesses which would prevent continuous participation in this clinical trial. Concurrent Medication: Excluded: - Patients with the following are excluded: Significant chronic underlying medical illnesses which would prevent continuous participation in this clinical trial. Unwilling to sign informed consent. Intolerant to zidovudine (AZT). Oral hairy leukoplakia at any time prior to study entry. Prior Medication: Excluded within 7 days of study entry: Antiretroviral drugs. Immunomodulators. Excluded within 30 days of study entry: Any investigational drugs. Patients have the following: HIV seropositivity by licensed ELISA test, confirmed by Western Blot analysis. No symptoms as defined by: Normal neurological exam. Absence of the following: Unintentional weight loss of greater than 10 pounds or more than 10 percent of usual body weight within 2 months prior to study entry. Unexplained temperature > 37.8 C on more than 5 consecutive days or on more than 10 days in any 30 day period in the one month prior to expected study entry. Unexplained diarrhea defined by = or > 3 liquid stools per day persisting > 7 days within 2 months prior to expected study entry.

Sites / Locations

  • Johns Hopkins Hosp

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
June 23, 2005
Sponsor
Lederle Laboratories
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1. Study Identification

Unique Protocol Identification Number
NCT00002271
Brief Title
An Ascending, Single Oral Dose Pharmacokinetic Study of 3'-Deoxy-3'-Fluorothymidine (FLT) in Asymptomatic Human Immunodeficiency Virus (HIV)-Infected Subjects
Official Title
An Ascending, Single Oral Dose Pharmacokinetic Study of 3'-Deoxy-3'-Fluorothymidine (FLT) in Asymptomatic Human Immunodeficiency Virus (HIV)-Infected Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
June 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
Lederle Laboratories

4. Oversight

5. Study Description

Brief Summary
To characterize the pharmacokinetics of orally administered 3'-deoxy-3'-fluorothymidine (FLT), in a liquid formulation, after single doses in asymptomatic HIV-infected patients and to assess the safety and tolerance of the single oral doses of FLT.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Thymidine, Nucleosides, Antiviral Agents

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Alovudine

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Exclusion Criteria Co-existing Condition: Patients with the following conditions or symptoms are excluded: Oral candida infection documented by morphology or by response to antifungal therapy within 2 months prior to study entry. Temperature > 37.8 degrees Centigrade. Malignancy other than cutaneous basal cell carcinoma or cervical carcinoma in situ. Significant chronic underlying medical illnesses which would prevent continuous participation in this clinical trial. Concurrent Medication: Excluded: - Patients with the following are excluded: Significant chronic underlying medical illnesses which would prevent continuous participation in this clinical trial. Unwilling to sign informed consent. Intolerant to zidovudine (AZT). Oral hairy leukoplakia at any time prior to study entry. Prior Medication: Excluded within 7 days of study entry: Antiretroviral drugs. Immunomodulators. Excluded within 30 days of study entry: Any investigational drugs. Patients have the following: HIV seropositivity by licensed ELISA test, confirmed by Western Blot analysis. No symptoms as defined by: Normal neurological exam. Absence of the following: Unintentional weight loss of greater than 10 pounds or more than 10 percent of usual body weight within 2 months prior to study entry. Unexplained temperature > 37.8 C on more than 5 consecutive days or on more than 10 days in any 30 day period in the one month prior to expected study entry. Unexplained diarrhea defined by = or > 3 liquid stools per day persisting > 7 days within 2 months prior to expected study entry.
Facility Information:
Facility Name
Johns Hopkins Hosp
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States

12. IPD Sharing Statement

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An Ascending, Single Oral Dose Pharmacokinetic Study of 3'-Deoxy-3'-Fluorothymidine (FLT) in Asymptomatic Human Immunodeficiency Virus (HIV)-Infected Subjects

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