Expired Study
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Baltimore, Maryland 21205


Purpose:

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.


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.


NCT ID:

NCT00002271


Primary Contact:

N/A


Backup Contact:

N/A


Location Contact:

Baltimore, Maryland 21205
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: September 24, 2017

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