The Effects of Illnesses on HIV Levels in the Body
- Conditions
- HIV Infections
- Registration Number
- NCT00000900
- Brief Summary
To describe the magnitude and duration of changes in HIV-1 RNA levels during and after an acute febrile illness. To identify factors associated with increases, i.e., type of illness ultimately diagnosed (bacterial, viral, fungal), CD4 cell count, and antiretroviral treatment regimen. To describe changes in phenotypic markers of immune activation/dysregulation of CD4 and CD8 lymphocyte subsets and their relationship to intercurrent illness. To describe changes in plasma cytokines and soluble activation markers and their relationship to plasma HIV-1 viremia during and after the onset of intercurrent illness. To characterize the viral biologic phenotype and the viral drug susceptibility genotype before, during, and after the onset of an acute febrile illness. To characterize the expression of HIV-1 co-receptors before, during, and after the onset of an acute febrile illness Repeated episodes of intercurrent infections have been postulated to be an important stimulus for progression of HIV infection. The study of intercurrent illness in patients with initially undetectable viral load removes viral load as a possible cause for virologic and immunologic changes and allows for a more direct association of the intercurrent illness with changes in viral load, viral HIV-1 phenotypes, viral HIV-1 genotypes, and T cell phenotypes. Studying intercurrent illness and viral load provides an opportunity to characterize the potentially dynamic changes not only in viral load but also in phenotypic markers of T cell activation, plasma cytokine levels, phenotypic and genotypic changes in circulating virus, and HIV-1 tropisms.
- Detailed Description
Repeated episodes of intercurrent infections have been postulated to be an important stimulus for progression of HIV infection. The study of intercurrent illness in patients with initially undetectable viral load removes viral load as a possible cause for virologic and immunologic changes and allows for a more direct association of the intercurrent illness with changes in viral load, viral HIV-1 phenotypes, viral HIV-1 genotypes, and T cell phenotypes. Studying intercurrent illness and viral load provides an opportunity to characterize the potentially dynamic changes not only in viral load but also in phenotypic markers of T cell activation, plasma cytokine levels, phenotypic and genotypic changes in circulating virus, and HIV-1 tropisms.
This is a study to determine whether patients exhibit a temporary burst of viral replication or other changes in response to intercurrent febrile illness. Although there is no study treatment, patients on this study must be co-enrolled in at least 1 other ACTG antiretroviral treatment study. Plasma HIV-1 RNA and other variables are measured at the time of presentation, on Day 3, and at Weeks 1, 2, 4, 8, 16, and 24.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 26
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (14)
Johns Hopkins Hosp
🇺🇸Baltimore, Maryland, United States
Univ of Hawaii
🇺🇸Honolulu, Hawaii, United States
Univ of Colorado Health Sciences Ctr
🇺🇸Denver, Colorado, United States
Univ of Miami School of Medicine
🇺🇸Miami, Florida, United States
Queens Med Ctr
🇺🇸Honolulu, Hawaii, United States
Julio Arroyo
🇺🇸West Columbia, South Carolina, United States
Univ of Nebraska Med Ctr
🇺🇸Omaha, Nebraska, United States
Bellevue Hosp / New York Univ Med Ctr
🇺🇸New York, New York, United States
Univ of North Carolina
🇺🇸Chapel Hill, North Carolina, United States
St Louis Regional Hosp / St Louis Regional Med Ctr
🇺🇸St. Louis, Missouri, United States
Univ of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Howard Univ
🇺🇸Washington, District of Columbia, United States
Univ of California / San Diego Treatment Ctr
🇺🇸San Diego, California, United States
Harvard (Massachusetts Gen Hosp)
🇺🇸Boston, Massachusetts, United States