NCT Number: NCT00001995
A Double-Blind Randomized Clinical Trial of a Rifabutin Regimen in the Treatment of Mycobacterium-Avium Complex (MAC) Bacteremia in Patients With AIDS
To determine if a drug regimen containing rifabutin will eradicate or decrease the numbers of Mycobacterium avium complex (MAC) organisms in blood, improve the symptoms associated with MAC infection, and increase survival in patients with AIDS. To assess the safety of the drug regimen.
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Notify MeKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Maricopa County Med Ctr, Phoenix, Arizona, United States
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Concurrent Medication:
Allowed:
- Zidovudine (AZT).
- Didanosine (ddI).
Patients must have the following:
- Diagnosis of AIDS as defined by the CDC.
- Blood cultures positive for Mycobacterium avium complex or for acid-fast bacilli (AFB).
- Provide written informed consent.
Prior Medication:
Allowed:
- If receiving zidovudine (AZT) or ddI must be taking the medication for at least 4 weeks prior to study entry.
- Required:
- Antipneumocystis prophylactic therapy for at least 4 weeks prior to study entry.
Exclusion criteria
Co-existing Condition:
Patients with the following conditions or symptoms are excluded:
- Known hypersensitivity to any of the study drugs.
Concurrent Medication:
Excluded:
- Other therapy for mycobacterial disease.
Patients with the following are excluded:
- Known hypersensitivity to any of the study drugs.
Prior Medication:
Excluded within 4 weeks:
- Therapy for mycobacterial disease.
- Antiretroviral drugs, other than zidovudine (AZT) or ddI.
- Investigational drugs, other than ddI.
Treatment and study plan
Sponsors and collaborators
Lead sponsor
Pharmacia
Industry
Registry information
Important dates
- First posted
- Aug 31, 2001
- Registry last updated
- Jun 24, 2005
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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