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A Phase I Trial to Evaluate the Safety and Pharmacokinetics of 1592U89

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Abacavir sulfate
Sponsored by
Burroughs Wellcome
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring Biological Availability, Reverse Transcriptase Inhibitors, Food-Drug Interactions, abacavir

Eligibility Criteria

13 Years - 55 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria Patients must have: HIV infection, as documented by ELISA/Western blot detection of HIV antibody, positive p24 antigen assay, positive viral culture, or other accepted technique. Written informed consent of parent or legal guardian if under age 18. Exclusion Criteria Co-existing Condition: Excluded: Debilitating disease, as a result of HIV or associated therapies, that, in the opinion of the investigator, might prevent the patient from completing 6-week dosing period. Malabsorption syndrome or other gastrointestinal dysfunction that might interfere with drug absorption. Concurrent Medication: Excluded: Prescription or over-the-counter medication that cannot be withheld for 48 hours prior to dosing and during the 6 dosing periods. (Note: Antiretrovirals must be withheld for 24 hours prior to dosing and during the day of dosing.) Other investigational treatments (treatments available through a Treatment IND or other expanded access mechanism is evaluated individually in consultation with the sponsor). Alcoholic beverages within 48 hours before dosing and during the day of dosing. Coffee, tea, and other xanthine-containing beverages and foods on the day of dosing. Patients with the following symptoms or conditions are excluded: History of hepatitis, pancreatitis, or cardiomyopathy within the last 5 years. Risk Behavior: Excluded: Current alcohol or illicit drug use that might interfere with the patient's ability to comply with the dosing schedule and protocol evaluations, as determined by the investigator.

Sites / Locations

  • Georgetown Univ Med Ctr
  • Ctr for Phase I Research

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

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

Unique Protocol Identification Number
NCT00002141
Brief Title
A Phase I Trial to Evaluate the Safety and Pharmacokinetics of 1592U89
Official Title
A Phase I Trial to Evaluate the Safety and Pharmacokinetics of 1592U89
Study Type
Interventional

2. Study Status

Record Verification Date
October 1994
Overall Recruitment Status
Completed
Study Start Date
July 1994 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Burroughs Wellcome

4. Oversight

5. Study Description

Brief Summary
To assess the safety of single oral doses of 1592U89 (abacavir succinate, ABC) administered to HIV-positive individuals. To determine the pharmacokinetics of 1592U89 after single oral doses. To determine the effects of food on the bioavailability of 1592U89.
Detailed Description
Patients are randomized in a double-blinded manner, with 12 patients entering the treatment arm and 6 patients entering the control arm. Patients in the treatment arm receive 6 single escalating doses of 1592U89 separated by at least a 6-day washout period. Patients in the control arm receive 6 single oral doses of placebo at least 6 days apart. The second and third doses of 1592U89 are equivalent. During these doses, investigators study the effects of food on the pharmacokinetics of 1592U89 by giving half of the patients the second dose with a standardized, high-fat breakfast and giving the other half the dose in a fasted state. During the third dose, patients are crossed over so that patients who received the second dose with a meal now receive it in a fasted state, and vice versa. Following the sixth dose, investigators break the blind. Patients who received 1592U89 take a seventh dose in solution form and return for follow-up at least 7 days later; patients who received placebo receive no further treatment or follow-up. Serial blood and urine samples are collected before and after each administration of 1592U89 (or placebo) for determination of plasma and urine concentrations of 1592U89, and investigators monitor patients closely for adverse events or abnormal laboratory test findings.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Biological Availability, Reverse Transcriptase Inhibitors, Food-Drug Interactions, abacavir

7. Study Design

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

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Abacavir sulfate

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria Patients must have: HIV infection, as documented by ELISA/Western blot detection of HIV antibody, positive p24 antigen assay, positive viral culture, or other accepted technique. Written informed consent of parent or legal guardian if under age 18. Exclusion Criteria Co-existing Condition: Excluded: Debilitating disease, as a result of HIV or associated therapies, that, in the opinion of the investigator, might prevent the patient from completing 6-week dosing period. Malabsorption syndrome or other gastrointestinal dysfunction that might interfere with drug absorption. Concurrent Medication: Excluded: Prescription or over-the-counter medication that cannot be withheld for 48 hours prior to dosing and during the 6 dosing periods. (Note: Antiretrovirals must be withheld for 24 hours prior to dosing and during the day of dosing.) Other investigational treatments (treatments available through a Treatment IND or other expanded access mechanism is evaluated individually in consultation with the sponsor). Alcoholic beverages within 48 hours before dosing and during the day of dosing. Coffee, tea, and other xanthine-containing beverages and foods on the day of dosing. Patients with the following symptoms or conditions are excluded: History of hepatitis, pancreatitis, or cardiomyopathy within the last 5 years. Risk Behavior: Excluded: Current alcohol or illicit drug use that might interfere with the patient's ability to comply with the dosing schedule and protocol evaluations, as determined by the investigator.
Facility Information:
Facility Name
Georgetown Univ Med Ctr
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
Ctr for Phase I Research
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States

12. IPD Sharing Statement

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A Phase I Trial to Evaluate the Safety and Pharmacokinetics of 1592U89

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