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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.
First Received: November 2, 1999   Last Updated: June 23, 2005   History of Changes
Sponsored by: Lederle Laboratories
Information provided by: NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier: NCT00002260
  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: Treatment, Open Label, Pharmacokinetics Study
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:

  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
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

Study ID Numbers: 054C, 81-3
Study First Received: November 2, 1999
Last Updated: June 23, 2005
ClinicalTrials.gov Identifier: NCT00002260     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:
Biological Availability
alovudine
Food

Study placed in the following topic categories:
Alovudine
Antimetabolites
Anti-Infective Agents
Sexually Transmitted Diseases, Viral
Acquired Immunodeficiency Syndrome
Dideoxynucleosides
Antiviral Agents
Immunologic Deficiency Syndromes
Reverse Transcriptase Inhibitors
Virus Diseases
Anti-Retroviral Agents
HIV Infections
Sexually Transmitted Diseases
Retroviridae Infections

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

ClinicalTrials.gov processed this record on September 02, 2009