NCT00002405

Brief Summary

The purpose of this study is to see if it is safe to give amprenavir (APV) to HIV-infected patients. This study also examines the effect APV has on the level of HIV in the blood. Earlier studies have shown that APV is effective in slowing the growth of HIV in the body. Patients who have failed previous anti-HIV treatment or who are unable to take other protease inhibitors (PIs) may benefit from the availability of a new PI such as APV.

Trial Health

80
On Track

Trial Health Score

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

Geographic Reach
1 country

1 active site

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

April 1, 1999

First QC Date

November 2, 1999

Last Update Submit

June 23, 2005

Conditions

HIV Infections

Keywords

Drug Therapy, CombinationHIV Protease InhibitorsVX 478Anti-HIV Agents

Interventions

AmprenavirDRUG

Eligibility Criteria

Age4 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients must have:
  • Documented HIV-1 infection.
  • Evidence of failure or intolerance (have experienced a treatment-limiting toxicity) to standard protease inhibitor therapy and, in the judgment of the physician, be unable to construct a viable treatment regimen without APV.
  • Consent of parent or guardian if less than 18 years old.

You may not qualify if:

  • Co-existing Condition:
  • Patients with the following symptoms or conditions are excluded:
  • Malabsorption syndrome or other gastrointestinal dysfunction which might interfere with drug absorption or render the patient unable to take oral medication.
  • Serious medical conditions such as diabetes, congestive heart failure, cardiomyopathy, or other cardiac dysfunction, which, in the opinion of the investigator, would compromise the safety of the patient.
  • Hepatic failure.
  • Renal failure requiring dialysis.
  • Patients with the following prior conditions are excluded:
  • History of clinically relevant pancreatitis or hepatitis within the last 6 months.
  • Prior Medication:
  • Excluded:
  • Previous treatment with APV.
  • Patients currently participating in, or who would qualify for or have access to, an enrolling study of APV (ACTG 398 and ACTG 400).
  • Risk Behavior:
  • Excluded:
  • Patients with current alcohol or illicit drug use which, in the investigator's opinion, may interfere with the patient's ability to comply with the requirements of the study.
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Glaxo Wellcome Inc

Research Triangle Park, North Carolina, 277093398, United States

Location

MeSH Terms

Conditions

HIV Infections

Interventions

amprenavir

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
not applicable
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: 1999-04

Locations

US(1)