NCT00002141

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for phase_1 hiv-infections

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 1994

Completed
5.3 years until next milestone

First Submitted

Initial submission to the registry

November 2, 1999

Completed
1.8 years until next milestone

First Posted

Study publicly available on registry

August 31, 2001

Completed
Last Updated

June 24, 2005

Status Verified

October 1, 1994

First QC Date

November 2, 1999

Last Update Submit

June 23, 2005

Conditions

HIV Infections

Keywords

Biological AvailabilityReverse Transcriptase InhibitorsFood-Drug Interactionsabacavir

Interventions

Abacavir sulfateDRUG

Eligibility Criteria

Age13 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

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:
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Georgetown Univ Med Ctr

Washington D.C., District of Columbia, 20007, United States

Location

Ctr for Phase I Research

Wichita, Kansas, 67214, United States

Location

MeSH Terms

Conditions

HIV Infections

Interventions

abacavir

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Design

Study Type
interventional
Phase
phase 1
Masking
DOUBLE
Purpose
TREATMENT
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 2, 1999

First Posted

August 31, 2001

Study Start

July 1, 1994

Last Updated

June 24, 2005

Record last verified: 1994-10

Locations

US(2)