NCT00002388

Brief Summary

The purpose of this study is to see if it is safe to give 1592U89 to HIV-infected patients. This study also examines the effect 1592U89 has on plasma viral load (the level of HIV in the blood).

Trial Health

80
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P50-P75 for phase_1 hiv-infections

Geographic Reach
1 country

3 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

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

November 1, 1998

First QC Date

November 2, 1999

Last Update Submit

June 23, 2005

Conditions

HIV Infections

Keywords

HIV-1Reverse Transcriptase InhibitorsAnti-HIV Agents

Interventions

Abacavir sulfateDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Concurrent Medication:
  • Allowed:
  • Prophylaxis for opportunistic infections.
  • Patients must have:
  • HIV-1 infection.
  • CD4 cell count 100 - 500 cells/mm3 within 3 to 5 weeks prior to study drug administration.
  • No active diagnosis of AIDS (other than non-visceral Kaposi's sarcoma) according to the 1993 CDC AIDS surveillance definition.

You may not qualify if:

  • Co-existing Condition:
  • Patients with the following conditions and symptoms are excluded:
  • Malabsorption syndrome or other gastrointestinal dysfunction that may interfere with drug absorption.
  • Chronic disease such as diabetes, congestive heart failure, cardiomyopathy, or other cardiac dysfunction that in the opinion of the investigator, would compromise the safety of the patient.
  • Concurrent Medication:
  • Excluded:
  • Immunomodulating agents.
  • Chemotherapeutic agents.
  • Antiretroviral therapy. NOTE:
  • Patients who elect to continue study treatment into the extended phase may, after consultation with their primary physician, combine 1592U89 at a recommended dose of 300 mg bid with other licensed antiretroviral drugs.
  • Concurrent Treatment:
  • Excluded:
  • Radiation therapy.
  • Patients with the following prior conditions are excluded:
  • History of clinically relevant hepatitis or pancreatitis within 6 months prior to study drug administration.
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Evanston Hosp / Clinical Pharmacology Unit

Evanston, Illinois, 60201, United States

Location

Fenway Community Health Ctr / Research Dept

Boston, Massachusetts, 02115, United States

Location

Albany Med College / Albany Med Ctr Hosp

Albany, New York, 12208, 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
Purpose
TREATMENT
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 2, 1999

First Posted

August 31, 2001

Last Updated

June 24, 2005

Record last verified: 1998-11

Locations

US(3)