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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
This study has been completed.
Study NCT00002271   Information provided by NIH AIDS Clinical Trials Information Service
First Received: November 2, 1999   Last Updated: June 23, 2005   History of Changes

November 2, 1999
June 23, 2005
 
 
 
 
Complete list of historical versions of study NCT00002271 on ClinicalTrials.gov Archive Site
 
 
 
An Ascending, Single Oral Dose Pharmacokinetic Study of 3'-Deoxy-3'-Fluorothymidine (FLT) in Asymptomatic Human Immunodeficiency Virus (HIV)-Infected Subjects
An Ascending, Single Oral Dose Pharmacokinetic Study of 3'-Deoxy-3'-Fluorothymidine (FLT) in Asymptomatic Human Immunodeficiency Virus (HIV)-Infected Subjects

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.

 
 
Interventional
Treatment, Dose Comparison, Pharmacokinetics Study
HIV Infections
Drug: Alovudine
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
 
 
 

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00002271
 
054A, 81-1
Lederle Laboratories
 
 
NIH AIDS Clinical Trials Information Service
June 1991

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP