Primary: To provide rifabutin to HIV positive patients in an attempt to prevent or delay
Mycobacterium avium Complex (MAC) infection by a daily dose of rifabutin.
Secondary: To further characterize the safety of rifabutin monotherapy in preventing or
delaying MAC bacteremia in HIV positive patients with CD4 counts = or < 200.
- Any medication with the exception of other investigational drugs not available under
a treatment IND, expanded access, or parallel track program.
Patients must have:
- Confirmed HIV infection.
- CD4 cell counts <= 200 cells/mm3.
- No evidence of disseminated MAC disease.
- Informed consent of parent or guardian if 12 to < 18 years of age.
- Pregnant females may be eligible. There are no studies of the safety or efficacy of
rifabutin in pregnant women. Rifabutin should be used during pregnancy only if the
potential benefit justifies the potential risk to the fetus. In addition, a
risk/benefit decision should consider the likelihood of a woman's developing MAC if
she does not receive prophylaxis. The risk of developing MAC rises substantially for
women with CD4 counts less than 100, although it can also develop in women with
higher CD4 counts. Women of reproductive potential who are not pregnant must use
contraception. They are encouraged to use means other than oral contraceptives.
Patients with the following symptoms and conditions are excluded:
- Known hypersensitivity to rifabutin, rifampin, or other rifamycins.
- Current infection due to MAC or other mycobacterial disease, or complaints consistent
- Other investigational drugs with the exception of those available under a treatment
IND, expanded access, or parallel track program. (Licensed products prescribed for
unlabeled indications are not considered investigational.)
Patients with the following prior conditions are excluded:
Prior infection due to MAC or other mycobacterial disease or complaints consistent with