Rifabutin Therapy for the Prevention of Mycobacterium Avium Complex (MAC) Bacteremia in HIV Positive Patients With CD4 Counts = or < 200: Treatment IND Study
Information provided by (Responsible Party)
NIH AIDS Clinical Trials Information Service
First received: November 2, 1999
Last updated: June 23, 2005
Last Verified: April 2003
History of Changes
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.
Mycobacterium Avium-intracellulare Infection
Drug : Rifabutin
Primary Purpose: Treatment
|Official Title:||Rifabutin Therapy for the Prevention of Mycobacterium Avium Complex (MAC) Bacteremia in HIV Positive Patients With CD4 Counts = or < 200: Treatment IND Study|
Further study details as provided by NIH AIDS Clinical Trials Information Service:
|Ages Eligible for Study:||12 Years and older|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Any medication with the exception of other investigational drugs not available under a treatment IND, expanded access, or parallel track program.
- 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.
- Known hypersensitivity to rifabutin, rifampin, or other rifamycins.
- Current infection due to MAC or other mycobacterial disease, or complaints consistent with tuberculosis.
- Other investigational drugs with the exception of those available under a treatment
Patients must have:
Patients with the following symptoms and conditions are excluded:
Patients with the following prior conditions are excluded:
Prior infection due to MAC or other mycobacterial disease or complaints consistent with tuberculosis.
Contacts and LocationsChoosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002080
Locations Show More
|United States, Pennsylvania|
|Saint Davids, Pennsylvania, United States, 19087|
Sponsors and CollaboratorsPharmacia
|ClinicalTrials.gov Identifier:||NCT00002080 History of Changes|
|Other Study ID Numbers:||109A|
|Study First Received:||November 2, 1999|
|Last Updated:||June 23, 2005|
Keywords provided by NIH AIDS Clinical Trials Information Service:Rifabutin
Acquired Immunodeficiency Syndrome
Mycobacterium avium Complex
Additional relevant MeSH terms:
Mycobacterium avium-intracellulare Infection
ClinicalTrials.gov processed this data on March 16, 2018
This information is provided by ClinicalTrials.gov.