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Home > "A" Clinical Trials Conditions > A Study to Learn More About MAC Disease and the Use of Anti-HIV Drugs in Patients with Advanced HIV Infection  A Study to Learn More About MAC Disease and the Use of Anti-HIV Drugs in Patients with Advanced HIV Infection
A Study to Learn More About MAC Disease and the Use of Anti-HIV Drugs in Patients with Advanced HIV Infection
For Condition: Mycobacterium avium-intracellulare Infection,HIV Infections
Status: Completed
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: The purpose of this study is to determine if infection with Mycobacterium avium complex (MAC) occurs in other parts of the body before it is found in the blood. This study also evaluates the relationships between the amount of HIV in the blood, immune system functions, and the presence of MAC infection. HIV-positive patients are at risk for MAC infection because their immune systems have been weakened by HIV. It is hoped that aggressive treatment with anti-HIV drugs may improve their immune systems enough to prevent against MAC.
Details: The intent of this study is to define more precisely the natural history and immunopathogenesis of MAC disease in the HIV-infected population. It is suggested that MAC disease in AIDS patients results both from specific immunologic deficiencies caused by HIV infection of the host and as a result of specific mycobacterial virulence properties. Therefore, aggressive antiretroviral drug treatment of HIV-infected patients at risk for DMAC due to specific immune deficiencies will improve these immune functions in such a manner as to resist DMAC. A total of 85 patients will be stratified at baseline into one of three groups: Group I - 40 patients at high risk for MAC infection are neither followed beyond baseline nor receive study treatment. Group II - 15 patients with DMAC, i.e., newly diagnosed MAC-bacteremic patients with no more than 72 hours prior treatment for MAC, receive individualized regimen of HAART for 48 weeks: nelfinavir (NEV), nevirapine (NVP), and nucleoside reverse transcriptase inhibitor(s) as per primary physician. Patients are evaluated through clinical, microbiologic, and virologic assessments, and intensive immunologic evaluations at Weeks 12, 24, and 48. Group III - 30 asymptomatic HIV-infected patients are further stratified (15 patients/stratum) by CD4 count (less than or equal to 50 cells/mm3 or 100-250 cells/mm3). Patients in Group III follow the same HAART regimen and evaluations as Group II patients and continue evaluations for up to 48 weeks, if an acceptable response is found within 12 weeks of entry. Patients in Stratum 1 of Group III receive MAC prophylaxis with azithromycin once weekly with follow-up evaluations as in Group II. Patients in Group III that have a positive MAC blood or bone marrow culture at any time during the study will, from that point on, follow the same schedule of evaluations as patients in Group II. [AS PER AMENDMENT 11/3/98: Up to 100 evaluable patients will now be studied. Group 2 is now modified to include up to an additional 15 evaluable patients with known MAC bacteremia and less than or equal to 7 days prior MAC treatment who are unable to commit to long-term follow-up (Group 2b); these patients will undergo only baseline evaluations. Group 2a consists of 15 evaluable patients with known MAC bacteremia and less than or equal to 7 days of prior MAC treatment who are willing and able to enter the follow-up phase.]
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria You may be eligible for this study if you: - Are HIV-positive. - Have a CD4 count under 50 cells/mm3 or between 100 and 250 cells/mm3 within 30 days of study entry. - Have at least one symptom (e.g., fever, diarrhea, or weight loss) suggestive of MAC infection. - Have MAC infection with 7 days or less of MAC treatment. - Have an HIV blood level greater than 10,000 copies/ml within 30 days of study entry. - Are 18 years of age or older. Exclusion Criteria You will not be eligible for this study if you: - Have any active infection (except for MAC in Group 2 patients) or any cancer. - Are unable to follow an acceptable anti-HIV drug regimen (Groups 2 and 3). - Are pregnant or breast-feeding.
Total Enrollment: 85
Location and Contact Information:
Overall Study Official:
RobMacGregor, Study Chair,
Univ of Pennsylvania at Philadelphia
Philadelphia, Pennsylvania, 19104
United States
Emory Univ
Atlanta, Georgia, 30308
United States
Stanford Univ Med Ctr
Stanford, California, 943055107
United States
Univ of Texas Southwestern Med Ctr of Dallas
Dallas, Texas, 75235
United States
Case Western Reserve Univ
Cleveland, Ohio, 44106
United States
Univ of Washington
Seattle, Washington, 98104
United States
Beth Israel Med Ctr
New York City, New York, 10003
United States
Ohio State Univ Hosp Clinic
Columbus, Ohio, 432101228
United States
Division of Inf Diseases/ Indiana Univ Hosp
Indianapolis, Indiana, 46202
United States
Univ of Texas Galveston
Galveston, Texas, 775550435
United States
Univ of California / San Diego Treatment Ctr
San Diego, California, 921036325
United States
Univ of Texas, Southwestern Med Ctr of Dallas
Dallas, Texas, 75390
United States
Howard Univ
Washington D.C., District of Columbia, 20059
United States
Univ of Cincinnati
Cincinnati, Ohio, 452670405
United States
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, 60612
United States
Univ of Miami School of Medicine
Miami, Florida, 331361013
United States
Univ of Rochester Medical Center
Rochester, New York, 14642
United States
SUNY / Erie County Med Ctr at Buffalo
Buffalo, New York, 14215
United States
Bellevue Hosp / New York Univ Med Ctr
New York City, New York, 10016
United States
Northwestern Univ Med School
Chicago, Illinois, 60611
United States
Univ of Southern California / LA County USC Med Ctr
Los Angeles, California, 900331079
United States
Univ of Alabama at Birmingham
Birmingham, Alabama, 35294
United States
St Vincent's Hosp / Mem Sloan-Kettering Cancer Ctr
New York City, New York, 10021
United States
Indiana Univ Hosp
Indianapolis, Indiana, 462025250
United States
Cook County Hosp
Chicago, Illinois, 60612
United States
Julio Arroyo
West Columbia, South Carolina, 29169
United States
Additional Information:
Study ID Numbers: ACTG 341;
Study Start Date:
Record last reviewed: June 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000895
Other Hiv Infections Studies:
1. The Safety and Effectiveness of Clarithromycin and Rifabutin Used Alone or in Combination to Prevent Mycobacterium Avium Complex (MAC) or Disseminated MAC Disease in HIV-Infected Patients
2. Rifabutin Therapy for the Prevention of Mycobacterium avium Complex (MAC) Bacteremia in AIDS Patients With CD4 Counts = or < 200: A Double-Blind, Placebo-Controlled Trial
3. Evaluation of Treatment for Mycobacterium Avium Complex (MAC) Infection in HIV-Infected Patients
4. A Study to Learn More About MAC Disease and the Use of Anti-HIV Drugs in Patients with Advanced HIV Infection
5. A Study of Viracept in AIDS Patients with Mycobacterium Avium Complex Disease (MAC)
Related Studies:
Other HIV Infections Clinical Trials
Other Indiana Clinical Trials
Other Indianapolis Clinical Trials
A Study to Learn More About MAC Disease and the Use of Anti-HIV Drugs in Patients with Advanced HIV Infection
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