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.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002271
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: June 1991
  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

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Primary Purpose: Treatment
Official Title: An Ascending, Single Oral Dose Pharmacokinetic Study of 3'-Deoxy-3'-Fluorothymidine (FLT) in Asymptomatic Human Immunodeficiency Virus (HIV)-Infected Subjects

Resource links provided by NLM:


Further study details as provided by NIH AIDS Clinical Trials Information Service:

  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

No publications provided

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

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

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immunologic Deficiency Syndromes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immune System Diseases
Alovudine
Dideoxynucleosides
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Anti-Retroviral Agents

ClinicalTrials.gov processed this record on April 15, 2014