The Effects of Treatment for Mycobacterium Avium Complex (MAC) on the Cells of HIV-Infected Patients

NCT00000860 | Completed

• 1 other identifier: ACTG 853
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 11

Brief Summary

To determine if treatment of MAC infection in HIV-1 infected persons is associated with the decreases in plasma levels of TNF-alpha. Infection with MAC is a poor prognostic indicator in persons with AIDS. Evidence suggests that this poor outcome is not simply a reflection of greater immune impairment in AIDS patients with MAC infection, but rather may be a direct or indirect consequence of infection with mycobacterium. Survival of AIDS patients with MAC is shorter than those without MAC. Studies show that treatment for MAC improves the survival of MAC infected patients to nearly the survival of AIDS patients without MAC. Treatment of MAC with clarithromycin containing regimens is associated with decreased symptoms and prolonged survival. There is evidence, however, that mycobacterial infection may enhance propagation of the human immunodeficiency virus through mechanisms that may involve enhanced expression of pro inflammatory cytokines. It is unclear to what extent cytokine abnormalities contribute to this symptom complex and to what extent treatment of MAC infection will reverse these cytokine abnormalities.

Conditions

Mycobacterium Avium-Intracellulare Infection; HIV Infections

Keywords

Tumor Necrosis Factor; AIDS-Related Opportunistic Infections; Mycobacterium avium-intracellulare Infection; Drug Therapy, Combination; Anti-HIV Agents

Eligibility Criteria

• Age: 13 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Concurrent Medication:
• Allowed:
• Patients should have successfully completed therapy or be on stable therapy for any acute infectious processes other than MAC prior to study entry.
• Patients must have:
• Documented HIV infection.
• Either symptomatic MAC disease as defined by a history of clinical signs and symptoms, plus one blood culture positive for MAC or AFB obtained within the previous 90 days, OR asymptomatic MAC disease as defined by 2 blood cultures positive for MAC or AFB obtained within 90 days of entry.
• Signed parental consent for patients less than 18 years of age.
• Prior Medication:
• Allowed:
• Patients who have received presumptive or empiric antimycobacterial therapy prior to study entry may be enrolled if they have been treated for no more than 72 hours prior to study entry.
• Patients who have been receiving prophylaxis with azithromycin, clarithromycin and/or rifabutin may be enrolled.
• Patients should have successfully completed therapy or be on stable therapy for any acute infectious processes other than MAC prior to study entry.
• Required:
• Patients must be on a stable antiretroviral regimen (same drug or combination drugs; dose modifications allowed) for at least 4 weeks prior to study entry.
• NOTE:

You may not qualify if:

• Co-existing Condition:
• Patients with the following symptoms or conditions are excluded:
• Previous enrollment and permanent study drug discontinuation in ACTG 223.
• Note:
• Co-enrollment in ACTG 223 and ACTG 853 is acceptable, however enrollment in both studies must be simultaneous.
• This protocol does not meet federal requirements governing prisoner participation in clinical trials and should not be considered by local IRBs for the recruitment of prisoners.
• Concurrent Medication:
• Excluded:
• Cytokine inhibitors.
• Corticosteroids.
• Thalidomide.
• Pentoxifylline or any other immunomodulator.
• Any interleukin.
• Colony stimulating factors (G-CSF or GM-CSF)
• Patients with the following prior conditions will be excluded:

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (11)

San Francisco Gen Hosp

San Francisco, California, 941102859, United States

Location

Univ of Colorado Health Sciences Ctr

Denver, Colorado, 80262, United States

Location

Washington Reg AIDS Prog / Dept of Infect Dis

Washington D.C., District of Columbia, 20422, United States

Location

Northwestern Univ Med School

Chicago, Illinois, 60611, United States

Location

Rush Presbyterian - Saint Luke's Med Ctr

Chicago, Illinois, 60612, United States

Location

Division of Inf Diseases/ Indiana Univ Hosp

Indianapolis, Indiana, 46202, United States

Location

Johns Hopkins Hosp

Baltimore, Maryland, 21287, United States

Location

Univ of Cincinnati

Cincinnati, Ohio, 452670405, United States

Location

Case Western Reserve Univ

Cleveland, Ohio, 44106, United States

Location

Univ of Pennsylvania at Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Univ of Washington

Seattle, Washington, 981224304, United States

Location

Related Publications (3)

• Benson CA. MAC: pathogenesis and treatment. Conf Retroviruses Opportunistic Infect. 1996 Jan 28-Feb 1;3rd:166

  BACKGROUND

• MacArthur RD, Lederman MM, Benson CA, Chernoff MC, MacGregor RR, Spritzler J, Mahon LF, Yen-Lieberman B, Purvis S. Effects of Mycobacterium avium complex-infection treatment on cytokine expression in human immunodeficiency virus-infected persons: results of AIDS clinical trials group protocol 853. J Infect Dis. 2000 Apr;181(4):1486-90. doi: 10.1086/315370. Epub 2000 Apr 13.

  PMID: 10762582 BACKGROUND

• MacArthur RD, Lederman M, Benson CA, Chernoff MC, Mahon LF, Yen-Lieberman B, Purvis S, MacGregor RR. ACTG 853: effects of treatment for MAC infection on cytokine expression in HIV-infected persons. Intersci Conf Antimicrob Agents Chemother. 1998 Sep 24-27;38:403 (abstract no I-130)

  BACKGROUND

MeSH Terms

Conditions

Mycobacterium avium-intracellulare Infection; HIV Infections; AIDS-Related Opportunistic Infections

Condition Hierarchy (Ancestors)

Mycobacterium Infections, Nontuberculous; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Opportunistic Infections

Study Officials

• MacArthur R

  STUDY CHAIR

• Benson C

  STUDY CHAIR

• Lederman M

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: NATURAL HISTORY
• Sponsor Type: NIH

Study Record Dates

• First Submitted: November 2, 1999
• First Posted: August 31, 2001
• Last Updated: June 24, 2005

Record last verified: 1999-07

Locations

US (11)