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Effects of Treatment for MAC Infection on Cytokine Expression in HIV-Infected Persons.


N/A
13 Years
N/A
Not Enrolling
Both
Mycobacterium Avium-Intracellulare Infection, HIV Infections

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Trial Information

Effects of Treatment for MAC Infection on Cytokine Expression in HIV-Infected Persons.


Infection with MAC is a poor prognostic indicator in persons with AIDS. Evidence suggests
that this poor outcome is not simply a reflection of greater immune impairment in AIDS
patients with MAC infection, but rather may be a direct or indirect consequence of infection
with mycobacterium. Survival of AIDS patients with MAC is shorter than those without MAC.
Studies show that treatment for MAC improves the survival of MAC infected patients to nearly
the survival of AIDS patients without MAC. Treatment of MAC with clarithromycin containing
regimens is associated with decreased symptoms and prolonged survival. There is evidence,
however, that mycobacterial infection may enhance propagation of the human immunodeficiency
virus through mechanisms that may involve enhanced expression of pro inflammatory cytokines.
It is unclear to what extent cytokine abnormalities contribute to this symptom complex and
to what extent treatment of MAC infection will reverse these cytokine abnormalities.

All patients diagnosed with MAC and who will initiate at least a 2 drug clarithromycin
containing MAC treatment regimen will be eligible for participation. Blood and urine will be
obtained from each patient at the following timepoints: Pre-Entry (within 7 days prior to
study entry), week 4, and week 8. Sites will process and ship specific samples to Case
Western Reserve University (CWRU). Various assays and analyses will be performed by CWRU.
NOTE: Patients will receive no treatment on this study, however, all patients must be
receiving at least a 2 drug clarithromycin containing treatment regimen for MAC either as
part of participation in other studies or as prescribed by the subject's health care
provider.

Inclusion Criteria


Inclusion Criteria

Concurrent Medication:

Allowed:

- Patients should have successfully completed therapy or be on stable therapy for any
acute infectious processes other than MAC prior to study entry.

Patients must have:

- Documented HIV infection.

- Either symptomatic MAC disease as defined by a history of clinical signs and
symptoms, plus one blood culture positive for MAC or AFB obtained within the previous
90 days, OR asymptomatic MAC disease as defined by 2 blood cultures positive for MAC
or AFB obtained within 90 days of entry.

- Signed parental consent for patients less than 18 years of age.

Prior Medication:

Allowed:

- Patients who have received presumptive or empiric antimycobacterial therapy prior to
study entry may be enrolled if they have been treated for no more than 72 hours prior
to study entry.

- Patients who have been receiving prophylaxis with azithromycin, clarithromycin and/or
rifabutin may be enrolled.

- Patients should have successfully completed therapy or be on stable therapy for any
acute infectious processes other than MAC prior to study entry.

Required:

- Patients must be on a stable antiretroviral regimen (same drug or combination drugs;
dose modifications allowed) for at least 4 weeks prior to study entry.

NOTE:

- Patients will be requested NOT to modify or add new drugs to their stable ARV regimen
for the duration of this study. Patients who absolutely require ARV changes at any
time prior to week 8 will continue on study, however, their data will be analyzed
separately.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

- Previous enrollment and permanent study drug discontinuation in ACTG 223.

Note:

- Co-enrollment in ACTG 223 and ACTG 853 is acceptable, however enrollment in both
studies must be simultaneous.

- This protocol does not meet federal requirements governing prisoner participation in
clinical trials and should not be considered by local IRBs for the recruitment of
prisoners.

Concurrent Medication:

Excluded:

- Cytokine inhibitors.

- Corticosteroids.

- Thalidomide.

- Pentoxifylline or any other immunomodulator.

- Any interleukin.

- Colony stimulating factors (G-CSF or GM-CSF)

Patients with the following prior conditions will be excluded:

- Subjects who have had an opportunistic infection (other than MAC) within 14 days
immediately preceding study entry.

Prior Medication:

Excluded within the 14 days immediately preceding study entry:

- Cytokine inhibitors.

- Corticosteroids.

- Thalidomide.

- Pentoxifylline or any other immunomodulator.

- Any interleukin.

- Colony stimulating factors (G-CSF or GM-CSF)

Prior Treatment:

Excluded:

- Patients who have received a blood transfusion within the 14 days immediately
preceding study entry.

Type of Study:

Observational

Study Design:

Observational Model: Natural History

Principal Investigator

MacArthur R

Investigator Role:

Study Chair

Authority:

United States: Federal Government

Study ID:

ACTG 853

NCT ID:

NCT00000860

Start Date:

Completion Date:

Related Keywords:

  • Mycobacterium Avium-Intracellulare Infection
  • HIV Infections
  • Tumor Necrosis Factor
  • AIDS-Related Opportunistic Infections
  • Mycobacterium avium-intracellulare Infection
  • Drug Therapy, Combination
  • Anti-HIV Agents
  • HIV Infections
  • Acquired Immunodeficiency Syndrome
  • Mycobacterium Infections
  • Mycobacterium avium-intracellulare Infection

Name

Location

San Francisco Gen HospSan Francisco, California  941102859
Univ of Colorado Health Sciences CtrDenver, Colorado  80262
Rush Presbyterian - Saint Luke's Med CtrChicago, Illinois  60612
Northwestern Univ Med SchoolChicago, Illinois  60611
Univ of WashingtonSeattle, Washington  98105
Johns Hopkins HospBaltimore, Maryland  21287
Univ of CincinnatiCincinnati, Ohio  452670405
Univ of Pennsylvania at PhiladelphiaPhiladelphia, Pennsylvania  19104
Case Western Reserve UnivCleveland, Ohio  44106
Division of Inf Diseases/ Indiana Univ HospIndianapolis, Indiana  46202
Washington Reg AIDS Prog / Dept of Infect DisWashington, District of Columbia  20422