An Open-Label, Crossover Study to Assess the Effect of Food on the Oral Bioavailability and Pharmacokinetic Profile 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:
NCT00002260
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: March 1992
  Purpose

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


Condition Intervention
HIV Infections
Drug: Alovudine

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label, Crossover Study to Assess the Effect of Food on the Oral Bioavailability and Pharmacokinetic Profile 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

Inclusion Criteria

Patients must have:

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

Exclusion Criteria

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.
  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002260

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: NCT00002260     History of Changes
Other Study ID Numbers: 054C, 81-3
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:
Biological Availability
alovudine
Food

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 September 14, 2014