Purpose:
The purpose of this study is to determine if infection with Mycobacterium avium complex
(MAC) occurs in other parts of the body before it is found in the blood. This study also
evaluates the relationships between the amount of HIV in the blood, immune system functions,
and the presence of MAC infection.
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.
Study summary:
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.]
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.