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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00002141
• Date of registration: 02/11/1999
• Primary sponsor: Burroughs Wellcome
• Public title: A Phase I Trial to Evaluate the Safety and Pharmacokinetics of 1592U89
• Scientific title: A Phase I Trial to Evaluate the Safety and Pharmacokinetics of 1592U89
• Date of first enrolment: July 1994
• Target sample size: 18
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00002141
• Study type: Interventional
• Study design: Endpoint Classification: Pharmacokinetics Study, Masking: Double-Blind, Primary Purpose: Treatment

Countries of recruitment

United States

Key inclusion & exclusion 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.



Age minimum: 13 Years
Age maximum: 55 Years
Gender: Both

Health Condition(s) or Problem(s) studied

HIV Infections

Intervention(s)

Drug: Abacavir sulfate

Secondary ID(s)

001

238A

Source(s) of Monetary Support

Please refer to primary and secondary sponsors