NCT00002260

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

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 2, 1999

Completed
1.8 years until next milestone

First Posted

Study publicly available on registry

August 31, 2001

Completed
Last Updated

June 24, 2005

Status Verified

March 1, 1992

First QC Date

November 2, 1999

Last Update Submit

June 23, 2005

Conditions

HIV Infections

Keywords

Biological AvailabilityalovudineFood

Interventions

AlovudineDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients must have:
  • Positive ELISA test confirmed by Western blot analysis.
  • Asymptomatic.
  • Willing to sign an informed consent.

You may not qualify if:

  • 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.
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins Hosp

Baltimore, Maryland, 21205, United States

Location

MeSH Terms

Conditions

HIV Infections

Interventions

alovudine

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Masking
NONE
Purpose
TREATMENT
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 2, 1999

First Posted

August 31, 2001

Last Updated

June 24, 2005

Record last verified: 1992-03

Locations

US(1)