NCT00006591

Brief Summary

The purpose of this study is to determine if treatment with an anti-HIV drug containing ritonavir and Agenerase is safe and can lower the level of HIV in the blood in patients who have failed an anti-HIV drug treatment containing nelfinavir.

Trial Health

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Monitor

Trial Health Score

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

Geographic Reach
1 country

1 active site

Status
unknown

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

December 1, 2000

Completed
9 months until next milestone

First Posted

Study publicly available on registry

August 31, 2001

Completed
Last Updated

June 24, 2005

Status Verified

December 1, 2004

First QC Date

December 1, 2000

Last Update Submit

June 23, 2005

Conditions

HIV Infections

Keywords

Drug Therapy, CombinationHIV Protease InhibitorsRitonavirVX 478Salvage TherapyAnti-HIV AgentsDrug MonitoringNelfinavirTreatment Experienced

Interventions

RitonavirDRUG
AmprenavirDRUG

Eligibility Criteria

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

You may qualify if:

  • Patients may be eligible for this study if they:
  • Are 18 years of age or older.
  • Are HIV-positive.
  • Have a viral load (level of HIV in the body) of more than 1,000 copies/ml.
  • Have had more than 12 weeks of prior anti-HIV drug treatment.
  • Have failed a previous anti-HIV treatment containing nelfinavir as the only protease inhibitor.
  • Are responsive to Agenerase.
  • Are able to follow study requirements.

You may not qualify if:

  • Patients will not be eligible for this study if they:
  • Are intolerant to ritonavir (an anti-HIV drug).
  • Have or have had problems with absorption.
  • Have liver disease or damage.
  • Have pancreatic disease or damage.
  • Have taken any protease inhibitor other than nelfinavir.
  • Are receiving investigational drugs or devices from another study.
  • Are pregnant or breast-feeding.
  • Currently use triazolam, astemizole, ergot medications, cisapride, midazolam, bepridil, rifampin, terfenadine, or pimozide.
  • Have a bleeding disorder.
  • Have previously been treated with Agenerase.
  • Are receiving nonnucleosides.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gathe, Joseph, M.D.

Houston, Texas, 77004, United States

Location

MeSH Terms

Conditions

HIV Infections

Interventions

Ritonaviramprenavir

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

ThiazolesSulfur CompoundsOrganic ChemicalsAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
not applicable
Purpose
TREATMENT
Sponsor Type
INDIV

Study Record Dates

First Submitted

December 1, 2000

First Posted

August 31, 2001

Last Updated

June 24, 2005

Record last verified: 2004-12

Locations

US(1)