NCT00002170

Brief Summary

The purpose of this study is to see if it is safe and effective to give Viracept to AIDS patients who are being treated for MAC.

Trial Health

80
On Track

Trial Health Score

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

Geographic Reach
1 country

5 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

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

May 1, 1999

First QC Date

November 2, 1999

Last Update Submit

June 23, 2005

Conditions

Mycobacterium Avium-Intracellulare InfectionHIV Infections

Keywords

AIDS-Related Opportunistic InfectionsPlacebosMycobacterium avium-intracellulare InfectionAcquired Immunodeficiency SyndromeHIV Protease InhibitorsNelfinavirAnti-Infective AgentsAnti-HIV Agents

Interventions

Nelfinavir mesylateDRUG

Eligibility Criteria

Age13 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients must have:
  • HIV infection
  • New diagnosis of MAC bacteremia and \< 7 days of therapy.
  • Prior Medication:
  • Allowed:
  • Patients no more than 7 days of therapy for MAC disease.

You may not qualify if:

  • Prior Medication:
  • Excluded:
  • Prior therapy (or less than 2 weeks) with protease inhibitors other than saquinavir.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Univ of California / San Diego Treatment Ctr

San Diego, California, 92103, United States

Location

Harbor UCLA Med Ctr

Torrance, California, 90502, United States

Location

Rush Presbyterian - Saint Luke's Med Ctr

Chicago, Illinois, 60612, United States

Location

Boston VA Med Ctr / 151

Boston, Massachusetts, 02730, United States

Location

Baylor Univ

Houston, Texas, 77009, United States

Location

MeSH Terms

Conditions

Mycobacterium avium-intracellulare InfectionHIV InfectionsAIDS-Related Opportunistic InfectionsAcquired Immunodeficiency Syndrome

Interventions

Nelfinavir

Condition Hierarchy (Ancestors)

Mycobacterium Infections, NontuberculousMycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsBlood-Borne InfectionsCommunicable DiseasesSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesOpportunistic InfectionsSlow Virus Diseases

Intervention Hierarchy (Ancestors)

IsoquinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 2
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: 1999-05

Locations

US(5)