A Phase I Trial to Evaluate the Safety and Pharmacokinetics of 1592U89
Completed · Phase 1
Conditions studied: HIV Infections
In brief
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.
Key facts
- Study ID
- NCT00002141
- Run by
- Burroughs Wellcome
- People needed
- 18
- Starts
- 1994-07-01
- Last updated by the study team
- 2005-06-24
Who can join
Age: 13 and older, up to 55. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Georgetown Univ Med Ctr — Washington D.C., District of Columbia, United States
- Ctr for Phase I Research — Wichita, Kansas, United States
Full record on ClinicalTrials.gov
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