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

Condition(s) targeted: Mycobacterium Avium-Intracellulare Infection; HIV Infections

Intervention: Azithromycin (Drug)

Phase: N/A

Status: Active, not recruiting

Sponsored by: National Institute of Allergy and Infectious Diseases (NIAID)

Official(s) and/or principal investigator(s):
Wafaa El-Sadr, Study Chair
William Burman, Study Chair

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.

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 design: Treatment, Parallel Assignment, Efficacy Study

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.]

Minimum age: 13 Years. Maximum age: N/A. Gender(s): Both.

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.

Community Consortium / UCSF, San Francisco, California 94110, United States

Community Consortium / Jon Kaiser Wellness Ctr, San Francisco, California 941102028, United States

Denver CPCRA / Denver Public Hlth, Denver, Colorado 802044507, United States

Washington Reg AIDS Prog / Dept of Infect Dis, Washington, District of Columbia 20422, United States

AIDS Research Consortium of Atlanta, Atlanta, Georgia 303081962, 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 701122699, United States

Henry Ford Hosp, Detroit, Michigan 48202, United States

Catherine McAuley Health Ctr, Detroit, Michigan 48201, United States

Wayne State Univ - WSU/DMC / Univ Hlth Ctr, Detroit, Michigan 48201, United States

North Jersey Community Research Initiative, Newark, New Jersey 071032842, United States

Southern New Jersey AIDS Cln Trials / Dept of Med, Camden, New Jersey 08103, 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 232980049, United States

Click here for more information about Azithromycin

Related publications:

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 for 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.

Last updated: June 23, 2005