A Study to Evaluate the Effects of Azithromycin on MAC Disease Prevention in HIV-Positive Patients
A Randomized, Double-Blind, Placebo-Controlled Trial of Prophylaxis for Disseminated Mycobacterium Avium Complex Disease and Bacterial Pneumonia Versus Deferred Prophylaxis in HIV-Infected Patients Who Experience Rebound in CD4+ Cell Count Due to Active Antiretroviral Therapy
2 other identifiers
interventional
850
1 country
19
Brief Summary
This study is designed to find out whether HIV-positive patients whose immune systems have improved after receiving anti-HIV treatment should take azithromycin to prevent Mycobacterium avium complex (MAC) disease. This study also examines the possibility of putting off MAC prevention treatment in patients who respond well to anti-HIV drug therapy. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 2, 1999
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2000
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedNovember 3, 2021
October 1, 2021
November 2, 1999
October 27, 2021
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- You may be eligible for this study if you:
- 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.
You may not qualify if:
- You will not be eligible for this study if you:
- Have/had MAC disease.
- Have been unable to take azithromycin in the past.
- Are on any medications that act against MAC.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (19)
Community Consortium / Jon Kaiser Wellness Ctr
San Francisco, California, 94110, United States
Community Consortium / UCSF
San Francisco, California, 94110, United States
Denver CPCRA / Denver Public Hlth
Denver, Colorado, 80204, United States
Washington Reg AIDS Prog / Dept of Infect Dis
Washington D.C., District of Columbia, 20422, United States
AIDS Research Consortium of Atlanta
Atlanta, Georgia, 30308, United States
AIDS Research Alliance - Chicago
Chicago, Illinois, 60657, United States
Louisiana Comm AIDS Rsch Prog / Tulane Univ Med
New Orleans, Louisiana, 70112, United States
LSMUC / Lions Clinic
New Orleans, Louisiana, 70112, United States
Catherine McAuley Health Ctr
Detroit, Michigan, 48201, United States
Wayne State Univ - WSU/DMC / Univ Hlth Ctr
Detroit, Michigan, 48201, United States
Henry Ford Hosp
Detroit, Michigan, 48202, United States
Southern New Jersey AIDS Cln Trials / Dept of Med
Camden, New Jersey, 08103, United States
North Jersey Community Research Initiative
Newark, New Jersey, 07103, United States
Partners in Research / New Mexico
Albuquerque, New Mexico, 87131, United States
Harlem AIDS Treatment Grp / Harlem Hosp Ctr
New York, New York, 10037, United States
The Research and Education Group
Portland, Oregon, 97210, United States
Philadelphia FIGHT
Philadelphia, Pennsylvania, 19107, United States
Saint Joseph's Hosp
Philadelphia, Pennsylvania, 19107, United States
Richmond AIDS Consortium / Div of Infect Diseases
Richmond, Virginia, 23298, United States
Related Publications (4)
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)
BACKGROUNDEl-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
BACKGROUNDEl-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)
BACKGROUNDEl-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.
PMID: 10766581BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Wafaa El-Sadr
- STUDY CHAIR
William Burman
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 2, 1999
First Posted
August 31, 2001
Study Completion
July 1, 2000
Last Updated
November 3, 2021
Record last verified: 2021-10