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.

Study Overview

• Status: Completed
• Conditions: HIV Infections
• Intervention / Treatment: Drug: Alovudine

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment

Collaborators and Investigators

• Sponsor: Lederle Laboratories

Study record dates

Study Major Dates

• Study Start: December 6, 2022
• Primary Completion: December 6, 2022
• Study Completion: December 6, 2022

Study Registration Dates

• First Submitted: November 2, 1999
• First Submitted That Met QC Criteria: August 30, 2001
• First Posted (Estimate): August 31, 2001

Study Record Updates

• Last Update Posted (Estimate): June 24, 2005
• Last Update Submitted That Met QC Criteria: June 23, 2005
• Last Verified: June 1, 1991

More Information

Terms related to this study

• Keywords: Thymidine; Nucleosides; Antiviral Agents
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases; HIV Infections; Acquired Immunodeficiency Syndrome; Anti-Infective Agents; Antiviral Agents; Alovudine
• Other Study ID Numbers: 054A; 81-1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No