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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Lederle Laboratories
• Treatments: Alovudine; Dideoxynucleosides

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.