An Open-Label Study of the Use of Azithromycin in Patients With Symptomatic Disseminated Mycobacterium Avium-Intracellulare Complex (MAC) Infection Failing Current Therapy
This study has been completed.
Sponsor:
Pfizer
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002089
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: July 1998
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Purpose
To evaluate the efficacy and safety of azithromycin given chronically for the treatment of Mycobacterium avium (MAC) bacteremia in patients failing or intolerant of current available MAC therapy.
Condition | Intervention |
---|---|
Mycobacterium Avium-Intracellulare Infection HIV Infections |
Drug: Azithromycin |
Study Type: | Interventional |
Study Design: | Endpoint Classification: Safety Study Masking: Open Label Primary Purpose: Treatment |
Official Title: | An Open-Label Study of the Use of Azithromycin in Patients With Symptomatic Disseminated Mycobacterium Avium-Intracellulare Complex (MAC) Infection Failing Current Therapy |
Resource links provided by NLM:
Further study details as provided by NIH AIDS Clinical Trials Information Service:
Eligibility
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria
Patients must have:
- Disseminated MAC as defined by current (within the last month) positive blood, bone marrow, or liver biopsy culture for MAC, and considered symptomatic (fever, night sweats, anorexia, weight loss, fatigue, or malaise).
- At least 2 months of prior treatment with available combination MAC therapy or less than 2 months of such accompanied by unacceptable adverse effects.
- Life expectancy of more than 2 weeks.
- Approval of eligibility from Pfizer Clinical Monitor.
- Consent of parent or guardian if under legal age of consent.
NOTE:
- Patients who have completed acute treatment with azithromycin for MAC in protocol 066-131 or 066-148 will be exempt from inclusion criteria 1 and 2 and can continue therapy through this protocol if their physician feels they have benefitted from prior azithromycin therapy.
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms and conditions are excluded:
- Known hypersensitivity or intolerance to macrolide antibiotics.
- Inability to take oral medications or current condition that is likely to interfere with absorption (e.g., gastrectomy).
Concurrent Medication:
Excluded:
- Other MAC therapy instituted during the first 2 months of the study.
- Other investigational drugs, with the exception of those available through a Treatment IND program.
Patients with the following prior conditions are excluded:
History of hypersensitivity or intolerance to azithromycin.
Prior Medication:
Excluded:
- Other investigational drugs within 7 days of enrollment, with the exception of Treatment IND drugs (such as ddC).
Contacts and Locations
More Information
No publications provided
Keywords provided by NIH AIDS Clinical Trials Information Service:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on March 14, 2013
No publications provided
ClinicalTrials.gov Identifier: | NCT00002089 History of Changes |
Other Study ID Numbers: | 058C, 066-162 |
Study First Received: | November 2, 1999 |
Last Updated: | June 23, 2005 |
Health Authority: | United States: Food and Drug Administration |
Keywords provided by NIH AIDS Clinical Trials Information Service:
Mycobacterium avium-intracellulare Infection Acquired Immunodeficiency Syndrome Azithromycin |
Additional relevant MeSH terms:
HIV Infections Acquired Immunodeficiency Syndrome 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 Slow Virus Diseases Actinomycetales Infections Gram-Positive Bacterial Infections Bacterial Infections Mycobacterium Infections, Atypical Azithromycin Anti-Bacterial Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on March 14, 2013