An Ascending, Single Oral Dose Pharmacokinetic Study of 3'-Deoxy-3'-Fluorothymidine (FLT) in Asymptomatic Human Immunodeficiency Virus (HIV)-Infected Subjects

Lederle Laboratories

Status: Completed

Conditions: HIV Infections

Treatments: Drug: Alovudine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00002271

81-1

054A

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.