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

L

Lederle Laboratories

Status

Completed

Conditions

HIV Infections

Treatments

Drug: Alovudine

Study type

Interventional

Funder types

Industry

Identifiers

NCT00002260
81-3
054C

Details and patient eligibility

About

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

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.

Trial contacts and locations

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Data sourced from clinicaltrials.gov

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