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An Open-Label, Crossover Study to Assess the Effect of Food on the Oral Bioavailability and Pharmacokinetic Profile 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 Biological Availability, alovudine, Food

Eligibility Criteria

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

Inclusion Criteria Patients must have: Positive ELISA test confirmed by Western blot analysis. Asymptomatic. Willing to sign an informed consent. Exclusion Criteria Co-existing Condition: Patients with the following conditions or symptoms are excluded: Oral candida infection documented by morphology or by a response to antifungal therapy within two months prior to study entry. Oral hairy leukoplakia at any time prior to entry. Temperature > 37.8 C. Any malignancy other than cutaneous basal cell carcinoma or cervical carcinoma in situ. Significant chronic underlying medical illness which would prevent continuous participation in this clinical trial. Unwilling to sign an informed consent. Zidovudine induced hematological toxicity. Prior Medication: Excluded: Therapy with antiretroviral drugs or immunomodulators within seven days before entry. Therapy with any investigational drug during the preceding 30 days. Patients may not have: Oral candida infection documented by morphology or by a response to antifungal therapy within two months prior to study entry. Oral hairy leukoplakia at any time prior to entry. Temperature > 37.8 C. Any malignancy other than cutaneous basal cell carcinoma or cervical carcinoma in situ. Significant chronic underlying medical illness which would prevent continuous participation in this clinical trial. Unwilling to sign an informed consent. Zidovudine induced hematological toxicity.

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
NCT00002260
Brief Title
An Open-Label, Crossover Study to Assess the Effect of Food on the Oral Bioavailability and Pharmacokinetic Profile of 3'-Deoxy-3'-Fluorothymidine (FLT) in Asymptomatic Human Immunodeficiency Virus (HIV)-Infected Subjects
Official Title
An Open-Label, Crossover Study to Assess the Effect of Food on the Oral Bioavailability and Pharmacokinetic Profile of 3'-Deoxy-3'-Fluorothymidine (FLT) in Asymptomatic Human Immunodeficiency Virus (HIV)-Infected Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
March 1992
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 FLT (in a liquid formulation) after single doses in both the fed and fasting states; to assess the effect of food on the oral bioavailability of FLT

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Biological Availability, alovudine, Food

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Masking
None (Open Label)

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
Inclusion Criteria Patients must have: Positive ELISA test confirmed by Western blot analysis. Asymptomatic. Willing to sign an informed consent. Exclusion Criteria Co-existing Condition: Patients with the following conditions or symptoms are excluded: Oral candida infection documented by morphology or by a response to antifungal therapy within two months prior to study entry. Oral hairy leukoplakia at any time prior to entry. Temperature > 37.8 C. Any malignancy other than cutaneous basal cell carcinoma or cervical carcinoma in situ. Significant chronic underlying medical illness which would prevent continuous participation in this clinical trial. Unwilling to sign an informed consent. Zidovudine induced hematological toxicity. Prior Medication: Excluded: Therapy with antiretroviral drugs or immunomodulators within seven days before entry. Therapy with any investigational drug during the preceding 30 days. Patients may not have: Oral candida infection documented by morphology or by a response to antifungal therapy within two months prior to study entry. Oral hairy leukoplakia at any time prior to entry. Temperature > 37.8 C. Any malignancy other than cutaneous basal cell carcinoma or cervical carcinoma in situ. Significant chronic underlying medical illness which would prevent continuous participation in this clinical trial. Unwilling to sign an informed consent. Zidovudine induced hematological toxicity.
Facility Information:
Facility Name
Johns Hopkins Hosp
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States

12. IPD Sharing Statement

Learn more about this trial

An Open-Label, Crossover Study to Assess the Effect of Food on the Oral Bioavailability and Pharmacokinetic Profile of 3'-Deoxy-3'-Fluorothymidine (FLT) in Asymptomatic Human Immunodeficiency Virus (HIV)-Infected Subjects

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