Back to resultsA Study of Viracept in AIDS Patients With Mycobacterium Avium Complex Disease (MAC)
Primary Purpose
Mycobacterium Avium-Intracellulare Infection, HIV Infections
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Nelfinavir mesylate
Sponsored by
About this trial
This is an interventional treatment trial for Mycobacterium Avium-Intracellulare Infection focused on measuring AIDS-Related Opportunistic Infections, Placebos, Mycobacterium avium-intracellulare Infection, Acquired Immunodeficiency Syndrome, HIV Protease Inhibitors, Nelfinavir, Anti-Infective Agents, Anti-HIV Agents
Eligibility Criteria
Inclusion Criteria 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. Exclusion Criteria Prior Medication: Excluded: Prior therapy (or less than 2 weeks) with protease inhibitors other than saquinavir.
Sites / Locations
- Univ of California / San Diego Treatment Ctr
- Harbor UCLA Med Ctr
- Rush Presbyterian - Saint Luke's Med Ctr
- Boston VA Med Ctr / 151
- Baylor Univ
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00002170
First Posted
November 2, 1999
Last Updated
June 23, 2005
Sponsor
Agouron Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT00002170
Brief Title
A Study of Viracept in AIDS Patients With Mycobacterium Avium Complex Disease (MAC)
Official Title
A Pilot, Phase II, Randomized, Placebo-Controlled Study to Determine the Effects of Viracept on the Clinical Outcome of Disseminated Mycobacterium Avium Complex Disease (MAC) in AIDS Patients Who Are Receiving Standard Acute Treatment for This Opportunistic Infection
Study Type
Interventional
2. Study Status
Record Verification Date
May 1999
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Agouron Pharmaceuticals
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mycobacterium Avium-Intracellulare Infection, HIV Infections
Keywords
AIDS-Related Opportunistic Infections, Placebos, Mycobacterium avium-intracellulare Infection, Acquired Immunodeficiency Syndrome, HIV Protease Inhibitors, Nelfinavir, Anti-Infective Agents, Anti-HIV Agents
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Nelfinavir mesylate
10. Eligibility
Sex
All
Minimum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria
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.
Exclusion Criteria
Prior Medication:
Excluded:
Prior therapy (or less than 2 weeks) with protease inhibitors other than saquinavir.
Facility Information:
Facility Name
Univ of California / San Diego Treatment Ctr
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Harbor UCLA Med Ctr
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
Facility Name
Rush Presbyterian - Saint Luke's Med Ctr
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Boston VA Med Ctr / 151
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02730
Country
United States
Facility Name
Baylor Univ
City
Houston
State/Province
Texas
ZIP/Postal Code
77009
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Study of Viracept in AIDS Patients With Mycobacterium Avium Complex Disease (MAC)
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