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Pathogenesis of MAC Disease in Advanced HIV-1-Infected Subjects and the Impact of Highly-Active Antiretroviral Treatment (HAART) on Immune Functions Relevant for MAC and Other Opportunistic Infections


N/A
18 Years
N/A
Not Enrolling
Both
Mycobacterium Avium-intracellulare Infection, HIV Infections

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Trial Information

Pathogenesis of MAC Disease in Advanced HIV-1-Infected Subjects and the Impact of Highly-Active Antiretroviral Treatment (HAART) on Immune Functions Relevant for MAC and Other Opportunistic Infections


The intent of this study is to define more precisely the natural history and
immunopathogenesis of MAC disease in the HIV-infected population. It is suggested that MAC
disease in AIDS patients results both from specific immunologic deficiencies caused by HIV
infection of the host and as a result of specific mycobacterial virulence properties.
Therefore, aggressive antiretroviral drug treatment of HIV-infected patients at risk for
DMAC due to specific immune deficiencies will improve these immune functions in such a
manner as to resist DMAC.

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.]

Inclusion Criteria


Inclusion Criteria

You may be eligible for this study if you:

- 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

You will not be eligible for this study if you:

- 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.

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Rob Roy MacGregor

Investigator Role:

Study Chair

Authority:

United States: Federal Government

Study ID:

ACTG 341

NCT ID:

NCT00000895

Start Date:

Completion Date:

August 2001

Related Keywords:

  • Mycobacterium Avium-Intracellulare Infection
  • HIV Infections
  • AIDS-Related Opportunistic Infections
  • Mycobacterium avium-intracellulare Infection
  • HIV-1
  • Drug Therapy, Combination
  • Acquired Immunodeficiency Syndrome
  • Mycobacterium avium Complex
  • Bacteremia
  • Nevirapine
  • HIV Protease Inhibitors
  • Risk Factors
  • RNA, Viral
  • Reverse Transcriptase Inhibitors
  • Nelfinavir
  • HIV Infections
  • Acquired Immunodeficiency Syndrome
  • Mycobacterium Infections
  • Mycobacterium avium-intracellulare Infection
  • Opportunistic Infections

Name

Location

Bellevue Hosp / New York Univ Med CtrNew York, New York  10016
Univ of Rochester Medical CenterRochester, New York  14642
Julio ArroyoWest Columbia, South Carolina  29169
Univ of California / San Diego Treatment CtrSan Diego, California  921036325
Univ of Miami School of MedicineMiami, Florida  331361013
Rush Presbyterian - Saint Luke's Med CtrChicago, Illinois  60612
Northwestern Univ Med SchoolChicago, Illinois  60611
Indiana Univ HospIndianapolis, Indiana  462025250
SUNY / Erie County Med Ctr at BuffaloBuffalo, New York  14215
Ohio State Univ Hosp ClinicColumbus, Ohio  432101228
Univ of WashingtonSeattle, Washington  98105
Univ of Alabama at BirminghamBirmingham, Alabama  35294
Univ of Southern California / LA County USC Med CtrLos Angeles, California  900331079
Cook County HospChicago, Illinois  60612
Beth Israel Med CtrNew York, New York  10003
Univ of CincinnatiCincinnati, Ohio  452670405
Univ of Pennsylvania at PhiladelphiaPhiladelphia, Pennsylvania  19104
Stanford Univ Med CtrStanford, California  943055107
Howard UnivWashington, District of Columbia  20059
Case Western Reserve UnivCleveland, Ohio  44106
Univ of Texas GalvestonGalveston, Texas  775550435
Emory UnivAtlanta, Georgia  30308
Division of Inf Diseases/ Indiana Univ HospIndianapolis, Indiana  46202
St Vincent's Hosp / Mem Sloan-Kettering Cancer CtrNew York, New York  10021
Univ of Texas Southwestern Med Ctr of DallasDallas, Texas  75235
Univ of Texas, Southwestern Med Ctr of DallasDallas, Texas  75390