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The Safety and Effectiveness of 524W91

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Emtricitabine
Sponsored by
Glaxo Wellcome
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Antiviral Agents

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • ViRx Inc

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
June 23, 2005
Sponsor
Glaxo Wellcome
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1. Study Identification

Unique Protocol Identification Number
NCT00002335
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 1996
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Glaxo Wellcome

4. Oversight

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Antiviral Agents

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Enrollment
18 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Emtricitabine

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
ViRx Inc
City
San Francisco
State/Province
California
ZIP/Postal Code
94103
Country
United States

12. IPD Sharing Statement

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The Safety and Effectiveness of 524W91

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