Rifabutin Therapy for the Prevention of Mycobacterium Avium Complex (MAC) Bacteremia in AIDS Patients With CD4 Counts = or < 200: A Double-Blind, Placebo-Controlled Trial
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| ClinicalTrials.gov Identifier: NCT00002032 |
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Recruitment Status :
Completed
First Posted : August 31, 2001
Last Update Posted : June 24, 2005
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Sponsor:
Pharmacia
Information provided by:
NIH AIDS Clinical Trials Information Service
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Brief Summary:
The primary objectives of this trial are: To compare the safety of oral rifabutin versus placebo in the treatment of Mycobacterium avium complex (MAC) bacteremia in AIDS patients with CD4 counts less than or equal to 200 cells/mm3. To investigate the incidence of MAC in these patients. A secondary objective is to compare clinical response, quality of life (Karnofsky), and survival between these two groups.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Mycobacterium Avium-intracellulare Infection HIV Infections | Drug: Rifabutin | Not Applicable |
| Study Type : | Interventional (Clinical Trial) |
| Enrollment : | 750 participants |
| Masking: | Double |
| Primary Purpose: | Treatment |
| Official Title: | Rifabutin Therapy for the Prevention of Mycobacterium Avium Complex (MAC) Bacteremia in AIDS Patients With CD4 Counts = or < 200: A Double-Blind, Placebo-Controlled Trial |
Resource links provided by the National Library of Medicine
Drug Information available for:
Rifabutin
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria
Patients must have the following:
- Diagnosis of AIDS with a case defining infection other than Mycobacterium avium complex (MAC).
- Written informed consent.
- Females of childbearing potential must also sign a special informed consent.
Exclusion Criteria
Co-existing Condition:
Patients with the following conditions or symptoms are excluded:
- Known hypersensitivity to rifabutin, rifampin, other rifamycins, zidovudine or didanosine (ddI).
- Previous or current infection due to Mycobacterium avium complex (MAC) disease as evaluated by two successive blood cultures and two successive stool cultures taken within 14 days prior to study initiation.
Concurrent Medication:
Excluded:
- Antiretroviral agents other than zidovudine (AZT).
- Didanosine (ddI).
- Antimycobacterial therapy.
- Rifampin.
- Isoniazid.
- Clofazimine.
- Ethambutol.
- Cycloserine.
- Ethionamide.
- Amikacin.
- Ciprofloxacin.
- Streptomycin.
- Other investigational drugs.
- If antimicrobial therapy is required to treat bacterial infections (= or < 14 days), Adria Laboratories must be contacted prior to initiation of therapy.
Patients with the following are excluded:
- Known hypersensitivity to rifabutin, rifampin, other rifamycins, zidovudine (AZT), or didanosine (ddI).
- Previous or current Mycobacterium avium complex (MAC) infection.
- Perceived patient unreliability or unavailability for frequent monitoring.
Prior Medication:
Excluded within 4 weeks of study entry:
- Antiretroviral agents other than zidovudine (AZT) or didanosine (ddI).
- Antimycobacterial therapy.
- Rifampin.
- Isoniazid.
- Clofazimine.
- Ethambutol.
- Cycloserine.
- Ethionamide.
- Amikacin.
- Ciprofloxacin.
Required:
- Zidovudine (AZT).
- Antipneumocystis prophylactic therapy.
Required for at least 4 weeks prior to study entry:
- Zidovudine (AZT) or didanosine (ddI).
- Antipneumocystis prophylaxis.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002032
Show 33 Study Locations
Sponsors and Collaborators
Pharmacia
Publications:
Dautzenberg B, Castellani P, Truffot-Pernot CH, Leng B, Sassella D. Bacteriological assessment of rifabutin versus placebo for M. avium bacteremia in AIDS patients. Int Conf AIDS. 1996 Jul 7-12;11(1):117 (abstract no MoB1359)
| ClinicalTrials.gov Identifier: | NCT00002032 History of Changes |
| Other Study ID Numbers: |
048A 087023-999 |
| First Posted: | August 31, 2001 Key Record Dates |
| Last Update Posted: | June 24, 2005 |
| Last Verified: | January 1992 |
Keywords provided by NIH AIDS Clinical Trials Information Service:
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Rifabutin AIDS-Related Opportunistic Infections Mycobacterium avium-intracellulare Infection Acquired Immunodeficiency Syndrome Antitubercular Agents |
Additional relevant MeSH terms:
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Infection Communicable Diseases HIV Infections Bacteremia Mycobacterium Infections Mycobacterium avium-intracellulare Infection Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases |
Bacterial Infections Sepsis Systemic Inflammatory Response Syndrome Inflammation Pathologic Processes Actinomycetales Infections Gram-Positive Bacterial Infections Mycobacterium Infections, Nontuberculous Rifabutin Anti-Bacterial Agents Anti-Infective Agents Antibiotics, Antitubercular Antitubercular Agents |