San Francisco, California 94103

  • HIV Infections

Purpose:

To assess the safety and pharmacokinetics of single oral doses of 524W91 administered in HIV-infected patients. To determine the effects of food on bioavailability of 524W91.


Study summary:

Patients are randomized to receive six single escalating doses of 524W91 or placebo, with each dose separated by at least a 6-day washout interval. In the time between 2 of the doses, the effect of food on pharmacokinetics will be investigated, with one dose administered in conjunction with a high-fat meal and one dose administered in a fasted state.


Criteria:

Inclusion Criteria Patients must have: - Documented HIV infection. - CD4 count >= 200 cells/mm3. - No active opportunistic infection. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: - Malignancy or other condition that would confound study assessment or interfere with ability to complete the study. - Malabsorption syndrome or other gastrointestinal dysfunction that might interfere with gastrointestinal absorption. Concurrent Medication: Excluded on the day of each dose: - Antiretrovirals. - Any prescription or over-the-counter medication. - Alcoholic beverages. - Coffee, tea, and other xanthine-containing beverages and foods. Patients with the following prior conditions are excluded: History of hepatitis, pancreatitis, or cardiomyopathy within the past 5 years. Prior Medication: Excluded: - Antiretrovirals within 24 hours prior to each dose. - Any prescription or over-the-counter medications within 48 hours prior to each dose. - Alcoholic beverages within 48 hours prior to each dose. Current alcohol or illicit drug use that may affect patient compliance.


Study is Available At:


Original ID:

233A


NCT ID:

NCT00002335


Secondary ID:


Study Acronym:


Brief Title:

The Safety and Effectiveness of 524W91


Official Title:

A Phase I, Randomized, Single-Dose, Placebo-Controlled Trial to Evaluate the Safety and Pharmacokinetics of 524W91


Overall Status:

Completed


Study Phase:

Phase 1


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

55 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

NIH AIDS Clinical Trials Information Service


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Endpoint Classification: Pharmacokinetics Study,


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

18


Enrollment Type:


Study Dates

Verification Date:April 1996
Last Changed Date:June 23, 2005
First Received Date:November 2, 1999

Study Outcomes

There are no available Study Outcomes

Study Interventions

Intervention Type:Drug
Name:Emtricitabine

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Glaxo Wellcome

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: July 26, 2021

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