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A Study to Evaluate the Effects of Azithromycin on MAC Disease Prevention in HIV-Positive Patients

Primary Purpose

Mycobacterium Avium-intracellulare Infection, HIV Infections

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Azithromycin
Sponsored by
National Institute of Allergy and Infectious Diseases (NIAID)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mycobacterium Avium-intracellulare Infection focused on measuring AIDS-Related Opportunistic Infections, Placebos, Mycobacterium avium-intracellulare Infection, Acquired Immunodeficiency Syndrome, Antitubercular Agents, Azithromycin, Drug Resistance, Microbial, CD4 Lymphocyte Count, Antibiotics, Time Factors, Anti-HIV Agents, Pneumonia, Bacterial, Streptococcus pneumoniae

Eligibility Criteria

13 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria 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. Exclusion Criteria 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.

Sites / Locations

  • Community Consortium / Jon Kaiser Wellness Ctr
  • Community Consortium / UCSF
  • Denver CPCRA / Denver Public Hlth
  • Washington Reg AIDS Prog / Dept of Infect Dis
  • AIDS Research Consortium of Atlanta
  • AIDS Research Alliance - Chicago
  • Louisiana Comm AIDS Rsch Prog / Tulane Univ Med
  • LSMUC / Lions Clinic
  • Catherine McAuley Health Ctr
  • Wayne State Univ - WSU/DMC / Univ Hlth Ctr
  • Henry Ford Hosp
  • Southern New Jersey AIDS Cln Trials / Dept of Med
  • North Jersey Community Research Initiative
  • Partners in Research / New Mexico
  • Harlem AIDS Treatment Grp / Harlem Hosp Ctr
  • The Research and Education Group
  • Philadelphia FIGHT
  • Saint Joseph's Hosp
  • Richmond AIDS Consortium / Div of Infect Diseases

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
October 27, 2021
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
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1. Study Identification

Unique Protocol Identification Number
NCT00000947
Brief Title
A Study to Evaluate the Effects of Azithromycin on MAC Disease Prevention in HIV-Positive Patients
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2000 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)

4. Oversight

5. Study Description

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.
Detailed Description
The need for MAC prophylaxis in advanced HIV disease is recognized. Prophylactic therapy is complicated, however, due to drug toxicity, potential drug interactions, patient noncompliance with multiagent regimens, microbial drug resistance, and high treatment costs. This study assesses the feasibility of deferring MAC prophylaxis in patients whose CD4+ cell counts rebound in response to antiretroviral therapy. 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.]

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mycobacterium Avium-intracellulare Infection, HIV Infections
Keywords
AIDS-Related Opportunistic Infections, Placebos, Mycobacterium avium-intracellulare Infection, Acquired Immunodeficiency Syndrome, Antitubercular Agents, Azithromycin, Drug Resistance, Microbial, CD4 Lymphocyte Count, Antibiotics, Time Factors, Anti-HIV Agents, Pneumonia, Bacterial, Streptococcus pneumoniae

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Enrollment
850 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Azithromycin

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria 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. Exclusion Criteria 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wafaa El-Sadr
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
William Burman
Official's Role
Study Chair
Facility Information:
Facility Name
Community Consortium / Jon Kaiser Wellness Ctr
City
San Francisco
State/Province
California
ZIP/Postal Code
94110
Country
United States
Facility Name
Community Consortium / UCSF
City
San Francisco
State/Province
California
ZIP/Postal Code
94110
Country
United States
Facility Name
Denver CPCRA / Denver Public Hlth
City
Denver
State/Province
Colorado
ZIP/Postal Code
80204
Country
United States
Facility Name
Washington Reg AIDS Prog / Dept of Infect Dis
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20422
Country
United States
Facility Name
AIDS Research Consortium of Atlanta
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Facility Name
AIDS Research Alliance - Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60657
Country
United States
Facility Name
Louisiana Comm AIDS Rsch Prog / Tulane Univ Med
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
LSMUC / Lions Clinic
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Catherine McAuley Health Ctr
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Wayne State Univ - WSU/DMC / Univ Hlth Ctr
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Henry Ford Hosp
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Southern New Jersey AIDS Cln Trials / Dept of Med
City
Camden
State/Province
New Jersey
ZIP/Postal Code
08103
Country
United States
Facility Name
North Jersey Community Research Initiative
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07103
Country
United States
Facility Name
Partners in Research / New Mexico
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131
Country
United States
Facility Name
Harlem AIDS Treatment Grp / Harlem Hosp Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10037
Country
United States
Facility Name
The Research and Education Group
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
Philadelphia FIGHT
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Saint Joseph's Hosp
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Richmond AIDS Consortium / Div of Infect Diseases
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States

12. IPD Sharing Statement

Citations:
Citation
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)
Results Reference
background
Citation
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
Results Reference
background
Citation
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)
Results Reference
background
PubMed Identifier
10766581
Citation
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.
Results Reference
background

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A Study to Evaluate the Effects of Azithromycin on MAC Disease Prevention in HIV-Positive Patients

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