ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  Related Studies  
An Ascending, Single Oral Dose Pharmacokinetic Study of 3'-Deoxy-3'-Fluorothymidine (FLT) in Asymptomatic Human Immunodeficiency Virus (HIV)-Infected Subjects

This study has been completed.

Sponsored by: Lederle Laboratories
Information provided by: NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier: NCT00002271
  Purpose

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.


Condition Intervention
HIV Infections
Drug: Alovudine

MedlinePlus related topics:   AIDS   

ChemIDplus related topics:   Thymidine    Alovudine   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Dose Comparison, Pharmacokinetics Study
Official Title:   An Ascending, Single Oral Dose Pharmacokinetic Study of 3'-Deoxy-3'-Fluorothymidine (FLT) in Asymptomatic Human Immunodeficiency Virus (HIV)-Infected Subjects
  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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:

    1. Normal neurological exam.
    2. 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.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002271

Locations
United States, Maryland
Johns Hopkins Hosp    
      Baltimore, Maryland, United States, 21205

Sponsors and Collaborators
Lederle Laboratories
  More Information


Study ID Numbers:   054A, 81-1
First Received:   November 2, 1999
Last Updated:   June 23, 2005
ClinicalTrials.gov Identifier:   NCT00002271
Health Authority:   United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:
Thymidine  
Nucleosides  
Antiviral Agents  

Study placed in the following topic categories:
Alovudine
Virus Diseases
Sexually Transmitted Diseases, Viral
HIV Infections
Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Dideoxynucleosides
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:
Antimetabolites
Anti-Infective Agents
RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Infection
Antiviral Agents
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Anti-Retroviral Agents
Therapeutic Uses
Lentivirus Infections
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on September 16, 2008




Links to all studies - primarily for crawlers