A Study to Learn More About MAC Disease and the Use of Anti-HIV Drugs in Patients With Advanced HIV Infection

Completed · Not applicable

Conditions studied: Mycobacterium Avium-intracellulare Infection, HIV Infections

In brief

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.

Key facts

Study ID

NCT00000895

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

85

Expected to finish

2001-08-01

Last updated by the study team

2021-10-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Univ of Alabama at Birmingham — Birmingham, Alabama, United States
• Univ of Southern California / LA County USC Med Ctr — Los Angeles, California, United States
• Univ of California / San Diego Treatment Ctr — San Diego, California, United States
• Stanford Univ Med Ctr — Stanford, California, United States
• Howard Univ — Washington D.C., District of Columbia, United States
• Univ of Miami School of Medicine — Miami, Florida, United States
• Emory Univ — Atlanta, Georgia, United States
• Northwestern Univ Med School — Chicago, Illinois, United States
• Cook County Hosp — Chicago, Illinois, United States
• Rush Presbyterian - Saint Luke's Med Ctr — Chicago, Illinois, United States
• Indiana Univ Hosp — Indianapolis, Indiana, United States
• Division of Inf Diseases/ Indiana Univ Hosp — Indianapolis, Indiana, United States
• SUNY / Erie County Med Ctr at Buffalo — Buffalo, New York, United States
• Beth Israel Med Ctr — New York, New York, United States
• Bellevue Hosp / New York Univ Med Ctr — New York, New York, United States
• St Vincent's Hosp / Mem Sloan-Kettering Cancer Ctr — New York, New York, United States
• Univ of Rochester Medical Center — Rochester, New York, United States
• Univ of Cincinnati — Cincinnati, Ohio, United States
• Case Western Reserve Univ — Cleveland, Ohio, United States
• Ohio State Univ Hosp Clinic — Columbus, Ohio, United States
• Univ of Pennsylvania at Philadelphia — Philadelphia, Pennsylvania, United States
• Julio Arroyo — West Columbia, South Carolina, United States
• Univ of Texas Southwestern Med Ctr of Dallas — Dallas, Texas, United States
• Univ of Texas, Southwestern Med Ctr of Dallas — Dallas, Texas, United States
• Univ of Texas Galveston — Galveston, Texas, United States

Full record on ClinicalTrials.gov

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