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Effects of MAC Preventive Therapy on Disease-Causing Bacteria in HIV-Infected Patients: A Substudy of CPCRA 048

NCT ID: NCT00000933

Last Updated: 2021-10-29

Study Results

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

326 participants

Study Classification

OBSERVATIONAL

Study Completion Date

2000-07-31

Brief Summary

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Some people who have taken azithromycin to prevent MAC (Mycobacterium avium Complex, a bacterial infection common in HIV-infected persons) have been found to carry antibiotic-resistant bacteria (germs that grow despite the presence of drugs used to kill them). The purpose of this study is to see if people who take azithromycin carry more antibiotic-resistant bacteria than people who have chosen to delay MAC preventive therapy.

When bacteria like Streptococcus (a type of bacteria that causes pneumonia and meningitis) are frequently exposed to antibiotics, the bacteria can become resistant to the drugs. MAC preventive therapy uses antibiotics, but this can make it difficult to treat other infections caused by bacteria that have become resistant in HIV-infected persons. If MAC preventive therapy is delayed, Streptococcus in the body may be less likely to develop resistance. Therefore, if the patient does get a Streptococcus infection, it will be easier to treat because it is not resistant to the antibiotics.

Detailed Description

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Streptococcus pneumoniae is a leading cause of bacteremia, pneumonia, meningitis, and otitis media in the United States. Prior to 1987, this organism was uniformly susceptible to penicillin; since then, however, increasing numbers of isolates resistant to penicillin, as well as to other common antibiotics, have been identified. Frequent exposure to antibiotics has been documented as an important risk factor for the emergence of resistant organisms in HIV-infected patients, who are more likely than uninfected people to be colonized with antibiotic-resistant strains of S. pneumoniae. This substudy is the first to examine the effects of withdrawing or delaying the initiation of prophylaxis (in this case, MAC prophylaxis) on the prevalence of antibiotic-resistant pneumococci in a prospective manner.

Study participants are a subset of those enrolled in the CR-MAC Protocol (CPCRA 048). Oropharyngeal swabs are taken at baseline and 4 months after randomization, and are used to isolate S. pneumoniae in culture. These isolates are tested for susceptibility to macrolides, penicillin, cephalosporins, quinolones, and TMP-SMX. The rates of pneumococcal colonization at baseline and 4 months after randomization are determined and used to estimate the impact of deferring MAC prophylaxis on carriage of antibiotic-resistant S. pneumoniae.

Conditions

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Mycobacterium Avium-intracellulare Infection HIV Infections Pneumococcal Infections

Keywords

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AIDS-Related Opportunistic Infections Mycobacterium avium-intracellulare Infection Antibiotics, Macrolide Azithromycin Drug Administration Schedule Drug Resistance, Microbial Carrier State Streptococcus pneumoniae

Eligibility Criteria

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Inclusion Criteria

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* Are enrolled in CPCRA 048.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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El-Sadr W

Role: STUDY_CHAIR

Burman W

Role: STUDY_CHAIR

Locations

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Community Consortium / UCSF

San Francisco, California, United States

Site Status

Denver CPCRA / Denver Public Hlth

Denver, Colorado, United States

Site Status

Washington Reg AIDS Prog / Dept of Infect Dis

Washington D.C., District of Columbia, United States

Site Status

AIDS Research Consortium of Atlanta

Atlanta, Georgia, United States

Site Status

AIDS Research Alliance - Chicago

Chicago, Illinois, United States

Site Status

Louisiana Comm AIDS Rsch Prog / Tulane Univ Med

New Orleans, Louisiana, United States

Site Status

Wayne State Univ - WSU/DMC / Univ Hlth Ctr

Detroit, Michigan, United States

Site Status

Henry Ford Hosp

Detroit, Michigan, United States

Site Status

Southern New Jersey AIDS Cln Trials / Dept of Med

Camden, New Jersey, United States

Site Status

North Jersey Community Research Initiative

Newark, New Jersey, United States

Site Status

Partners in Research / New Mexico

Albuquerque, New Mexico, United States

Site Status

Harlem AIDS Treatment Grp / Harlem Hosp Ctr

New York, New York, United States

Site Status

The Research and Education Group

Portland, Oregon, United States

Site Status

Philadelphia FIGHT

Philadelphia, Pennsylvania, United States

Site Status

Richmond AIDS Consortium / Div of Infect Diseases

Richmond, Virginia, United States

Site Status

Countries

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United States

References

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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 (abstract no 129)

Reference Type BACKGROUND

Other Identifiers

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11607

Identifier Type: REGISTRY

Identifier Source: secondary_id

Parent Study CPCRA 048

Identifier Type: -

Identifier Source: secondary_id

CPCRA 054

Identifier Type: -

Identifier Source: org_study_id