A Study to Evaluate the Effects of Azithromycin on MAC Disease Prevention in HIV-Positive Patients
NCT ID: NCT00000947
Last Updated: 2021-11-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
850 participants
INTERVENTIONAL
2000-07-31
Brief Summary
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Azithromycin is approved for the prevention of MAC disease in people with HIV and low CD4 cell counts. However, some people who have taken azithromycin have been found to carry antibiotic-resistant bacteria (germs that can grow despite the presence of drugs used to kill them). It is not known whether the risks associated with taking azithromycin outweigh the risk of getting MAC disease.
Detailed Description
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In this double-blind, placebo-controlled trial, patients are randomized to receive azithromycin weekly or matching placebo. Patients are switched to open-label azithromycin if they have an average CD4+ cell count less than 50 cells/mm3 on 2 consecutive counts obtained at least 48 hours apart (preferably no more than 60 days).
\[AS PER AMENDMENT 10/23/97: SUBSTUDY CPCRA 054: A subset of participants of CPCRA 048 have oropharyngeal swabs taken at baseline and 4 months after randomization. Antibiotic susceptibility tests are then performed on isolates of S. pneumoniae.\] \[AS PER AMENDMENT 9/3/99: Participants in protocol version 3.0 are followed for data collection purposes every 4 months for 18 months until January 31, 2001. Data collection includes CD4 cell counts, viral RNA measurements, macrolide susceptibility in MAC isolates, and antibiotic susceptibility of isolates from bacterial pneumonia episodes.\]
Conditions
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Keywords
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Study Design
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PARALLEL
TREATMENT
Interventions
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Azithromycin
Eligibility Criteria
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Inclusion Criteria
* Are HIV-positive.
* Have 2 CD4 counts over 100 cells/mm3 at least 30 days apart.
* Have a history of CD4 counts under 50 cells/mm3.
* Are at least 13 years old (need consent if under 18).
* Are in reasonably good health.
* Are expected to live for at least 6 months.
* Are receiving anti-HIV medications at study entry.
Exclusion Criteria
* Have/had MAC disease.
* Have been unable to take azithromycin in the past.
* Are on any medications that act against MAC.
13 Years
ALL
No
Sponsors
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National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Responsible Party
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Principal Investigators
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Wafaa El-Sadr
Role: STUDY_CHAIR
William Burman
Role: STUDY_CHAIR
Locations
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Community Consortium / Jon Kaiser Wellness Ctr
San Francisco, California, United States
Community Consortium / UCSF
San Francisco, California, United States
Denver CPCRA / Denver Public Hlth
Denver, Colorado, United States
Washington Reg AIDS Prog / Dept of Infect Dis
Washington D.C., District of Columbia, United States
AIDS Research Consortium of Atlanta
Atlanta, Georgia, United States
AIDS Research Alliance - Chicago
Chicago, Illinois, United States
Louisiana Comm AIDS Rsch Prog / Tulane Univ Med
New Orleans, Louisiana, United States
LSMUC / Lions Clinic
New Orleans, Louisiana, United States
Catherine McAuley Health Ctr
Detroit, Michigan, United States
Wayne State Univ - WSU/DMC / Univ Hlth Ctr
Detroit, Michigan, United States
Henry Ford Hosp
Detroit, Michigan, United States
Southern New Jersey AIDS Cln Trials / Dept of Med
Camden, New Jersey, United States
North Jersey Community Research Initiative
Newark, New Jersey, United States
Partners in Research / New Mexico
Albuquerque, New Mexico, United States
Harlem AIDS Treatment Grp / Harlem Hosp Ctr
New York, New York, United States
The Research and Education Group
Portland, Oregon, United States
Philadelphia FIGHT
Philadelphia, Pennsylvania, United States
Saint Joseph's Hosp
Philadelphia, Pennsylvania, United States
Richmond AIDS Consortium / Div of Infect Diseases
Richmond, Virginia, United States
Countries
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References
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Burman W, El-Sadr W, Grant L, Matts J, Zeh D, Gallagher B, Hafner R, Crane L, Gordin F. Low rates of all opportunistic infections among patients with advanced HIV disease responding to antiretroviral therapy - the CPCRA 048 Cohort. 7th Conf Retroviruses Opportunistic Infect. 2000 Jan 30-Feb 2 (abstract no 241)
El-Sadr WM, Manneheimer S, Grant L, Matts J. Use of PCP and MAC prophylaxis among eligible patients with and without CD4+ rebound. 39th Intersci Conf Antimicrob Agents Chemother. 1999 Sept 26-29
El-Sadr WM, Burman W, Grant L, Matts JP, Zeh D, Crane L, Gallagher B, Gordin F, Hafner R. Prophylaxis for Mycobacterium avium Complex can be deferred among patients with a past CD4 count <50 cells/mm3 who responded to antiretroviral therapy: results of a placebo-controlled trial (CPCRA 048). 7th Conf Retroviruses Opportunistic Infect. 2000 Jan 30-Feb 2 (abstract no 247)
El-Sadr WM, Burman WJ, Grant LB, Matts JP, Hafner R, Crane L, Zeh D, Gallagher B, Mannheimer SB, Martinez A, Gordin F. Discontinuation of prophylaxis against Mycobacterium avium complex disease in HIV-infected patients who have a response to antiretroviral therapy. Terry Beirn Community Programs for Clinical Research on AIDS. N Engl J Med. 2000 Apr 13;342(15):1085-92. doi: 10.1056/NEJM200004133421503.
Other Identifiers
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11600
Identifier Type: REGISTRY
Identifier Source: secondary_id
CPCRA 048
Identifier Type: -
Identifier Source: org_study_id