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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Brief Summary

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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.

Detailed Description

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Conditions

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HIV Infections

Study Design

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Primary Study Purpose

TREATMENT

Interventions

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Alovudine

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Locations

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Johns Hopkins Hosp

Baltimore, Maryland, United States

Site Status

Countries

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United States

Other Identifiers

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81-1

Identifier Type: -

Identifier Source: secondary_id

054A