A Study to Learn More About MAC Disease and the Use of Anti-HIV Drugs in Patients With Advanced HIV Infection
NCT ID: NCT00000895
Last Updated: 2021-10-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
85 participants
INTERVENTIONAL
2001-08-31
Brief Summary
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HIV-positive patients are at risk for MAC infection because their immune systems have been weakened by HIV. It is hoped that aggressive treatment with anti-HIV drugs may improve their immune systems enough to prevent against MAC.
Detailed Description
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A total of 85 patients will be stratified at baseline into one of three groups:
Group I - 40 patients at high risk for MAC infection are neither followed beyond baseline nor receive study treatment.
Group II - 15 patients with DMAC, i.e., newly diagnosed MAC-bacteremic patients with no more than 72 hours prior treatment for MAC, receive individualized regimen of HAART for 48 weeks: nelfinavir (NEV), nevirapine (NVP), and nucleoside reverse transcriptase inhibitor(s) as per primary physician. Patients are evaluated through clinical, microbiologic, and virologic assessments, and intensive immunologic evaluations at Weeks 12, 24, and 48.
Group III - 30 asymptomatic HIV-infected patients are further stratified (15 patients/stratum) by CD4 count (less than or equal to 50 cells/mm3 or 100-250 cells/mm3). Patients in Group III follow the same HAART regimen and evaluations as Group II patients and continue evaluations for up to 48 weeks, if an acceptable response is found within 12 weeks of entry. Patients in Stratum 1 of Group III receive MAC prophylaxis with azithromycin once weekly with follow-up evaluations as in Group II. Patients in Group III that have a positive MAC blood or bone marrow culture at any time during the study will, from that point on, follow the same schedule of evaluations as patients in Group II.
\[AS PER AMENDMENT 11/3/98: Up to 100 evaluable patients will now be studied. Group 2 is now modified to include up to an additional 15 evaluable patients with known MAC bacteremia and less than or equal to 7 days prior MAC treatment who are unable to commit to long-term follow-up (Group 2b); these patients will undergo only baseline evaluations. Group 2a consists of 15 evaluable patients with known MAC bacteremia and less than or equal to 7 days of prior MAC treatment who are willing and able to enter the follow-up phase.\]
Conditions
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Keywords
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Study Design
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TREATMENT
Interventions
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Nelfinavir mesylate
Nevirapine
Azithromycin
Eligibility Criteria
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Inclusion Criteria
* Are HIV-positive.
* Have a CD4 count under 50 cells/mm3 or between 100 and 250 cells/mm3 within 30 days of study entry.
* Have at least one symptom (e.g., fever, diarrhea, or weight loss) suggestive of MAC infection.
* Have MAC infection with 7 days or less of MAC treatment.
* Have an HIV blood level greater than 10,000 copies/ml within 30 days of study entry.
* Are 18 years of age or older.
Exclusion Criteria
* Have any active infection (except for MAC in Group 2 patients) or any cancer.
* Are unable to follow an acceptable anti-HIV drug regimen (Groups 2 and 3).
* Are pregnant or breast-feeding.
18 Years
ALL
No
Sponsors
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National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Responsible Party
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Principal Investigators
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Rob Roy MacGregor
Role: STUDY_CHAIR
David Perlman
Role: STUDY_CHAIR
Locations
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Univ of Alabama at Birmingham
Birmingham, Alabama, United States
Univ of Southern California / LA County USC Med Ctr
Los Angeles, California, United States
Univ of California / San Diego Treatment Ctr
San Diego, California, United States
Stanford Univ Med Ctr
Stanford, California, United States
Howard Univ
Washington D.C., District of Columbia, United States
Univ of Miami School of Medicine
Miami, Florida, United States
Emory Univ
Atlanta, Georgia, United States
Northwestern Univ Med School
Chicago, Illinois, United States
Cook County Hosp
Chicago, Illinois, United States
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, United States
Indiana Univ Hosp
Indianapolis, Indiana, United States
Division of Inf Diseases/ Indiana Univ Hosp
Indianapolis, Indiana, United States
SUNY / Erie County Med Ctr at Buffalo
Buffalo, New York, United States
Beth Israel Med Ctr
New York, New York, United States
Bellevue Hosp / New York Univ Med Ctr
New York, New York, United States
St Vincent's Hosp / Mem Sloan-Kettering Cancer Ctr
New York, New York, United States
Univ of Rochester Medical Center
Rochester, New York, United States
Univ of Cincinnati
Cincinnati, Ohio, United States
Case Western Reserve Univ
Cleveland, Ohio, United States
Ohio State Univ Hosp Clinic
Columbus, Ohio, United States
Univ of Pennsylvania at Philadelphia
Philadelphia, Pennsylvania, United States
Julio Arroyo
West Columbia, South Carolina, United States
Univ of Texas Southwestern Med Ctr of Dallas
Dallas, Texas, United States
Univ of Texas, Southwestern Med Ctr of Dallas
Dallas, Texas, United States
Univ of Texas Galveston
Galveston, Texas, United States
Univ of Washington
Seattle, Washington, United States
Countries
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References
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MacGregor RR, Hafner R, Wu JW, Murphy RL, Perlman DC, Bermudez LE, Inderlied CB, Picker LJ, Wallis RS, Andersen JW, Mahon LF, Koletar SL, Peterson DM; ACTG Protocol 341 Team. Clinical, microbiological, and immunological characteristics in HIV-infected subjects at risk for disseminated Mycobacterium avium complex disease: an AACTG study. AIDS Res Hum Retroviruses. 2005 Aug;21(8):689-95. doi: 10.1089/aid.2005.21.689.
Other Identifiers
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11312
Identifier Type: REGISTRY
Identifier Source: secondary_id
ACTG 341
Identifier Type: -
Identifier Source: org_study_id