Clareo Health | An Ascending, Single Oral Dose Pharmacokinetic Study of 3'-Deoxy-3'-Fluorothymidine (FLT) in Asymptomatic Human Immunodeficiency Virus (HIV)-Infected Subjects
An Ascending, Single Oral Dose Pharmacokinetic Study of 3'-Deoxy-3'-Fluorothymidine (FLT) in Asymptomatic Human Immunodeficiency Virus (HIV)-Infected Subjects
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Lederle Laboratories
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may not be if
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.