An Open-Label, Crossover Study to Assess the Effect of Food on the Oral Bioavailability and Pharmacokinetic Profile 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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

To characterize the pharmacokinetics of orally administered FLT (in a liquid formulation) after single doses in both the fed and fasting states; to assess the effect of food on the oral bioavailability of FLT

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

HIV Infections

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Alovudine

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

Patients must have:

* Positive ELISA test confirmed by Western blot analysis.
* Asymptomatic.
* Willing to sign an informed consent.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions or symptoms are excluded:

* Oral candida infection documented by morphology or by a response to antifungal therapy within two months prior to study entry.
* Oral hairy leukoplakia at any time prior to entry.
* Temperature \> 37.8 C.
* Any malignancy other than cutaneous basal cell carcinoma or cervical carcinoma in situ.
* Significant chronic underlying medical illness which would prevent continuous participation in this clinical trial.
* Unwilling to sign an informed consent.
* Zidovudine induced hematological toxicity.

Prior Medication:

Excluded:

* Therapy with antiretroviral drugs or immunomodulators within seven days before entry.
* Therapy with any investigational drug during the preceding 30 days.

Patients may not have:

* Oral candida infection documented by morphology or by a response to antifungal therapy within two months prior to study entry.
* Oral hairy leukoplakia at any time prior to entry.
* Temperature \> 37.8 C.
* Any malignancy other than cutaneous basal cell carcinoma or cervical carcinoma in situ.
* Significant chronic underlying medical illness which would prevent continuous participation in this clinical trial.
* Unwilling to sign an informed consent.
* Zidovudine induced hematological toxicity.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Johns Hopkins Hosp

Baltimore, Maryland, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

81-3

Identifier Type: -

Identifier Source: secondary_id

054C