Completed
The Impact of Intercurrent Illness on HIV Viral Load
Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2005-06-24
26
Participants Needed
14
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
The Effects of Illnesses on HIV Levels in the Body
Who Can Participate
Eligibility Criteria
You may qualify if you...
Inclusion Criteria
Patients must have:
- HIV-1 infection documented by any licensed ELISA test kit and confirmed by either Western blot, HIV-1 culture, HIV-1 antigen, plasma HIV-1 RNA or a second antibody test by a method other than ELISA at any time prior to study entry.
- Undetectable plasma HIV-1 RNA (by Roche Amplicor Assay) within 8 weeks prior to study entry.
- Documented temperature above 101degrees F during at least 1 of the 2 days prior to the day of screening and present on the day of screening, or documented temperature above 101 F on the day of the screening but no fever on 1 of the 2 days prior to screening.
[AS PER AMENDMENT 7/7/98:
- Documented temperature above 101degrees F on the day of the screening.]
- Co-enrollment in at least 1 other ACTG antiretroviral treatment study (NOTE:
- Co-enrollment is approved and encouraged with the following ACTG studies:
- 343, 347, 359, 368, 370, and 372). [AS PER AMENDMENT 7/7/98: Must be enrolled in either an ACTG antiretroviral therapy study or a pharmaceutical company-sponsored antiretroviral therapy study prior to entry. Co-enrolled in a non-ACTG pharmaceutical company-based study must have a baseline viral isolate accessible for use in this study.]
- Written informed consent of a parent or guardian if under 18 years of age.
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
- Interruption of current antiretroviral therapy due to the onset of acute intercurrent illness.
Concurrent Medication:
Excluded:
- Patients receiving IL-2.
Patients with the following prior conditions are excluded:
- Change in antiretroviral therapy combination within 8 weeks prior to study entry.
Required:
- Concurrent enrollment in an ACTG antiretroviral therapy study [or, AS PER AMENDMENT 7/7/98, in a non-ACTG pharmaceutical company-sponsored antiretroviral treatment study].
- Stable antiretroviral and/or nucleoside analog therapy for 8 weeks prior to study entry.
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
Trial Site Locations
Total: 14 locations
1
Univ of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
Status Unknown
2
Univ of California / San Diego Treatment Ctr
San Diego, California, United States, 921036325
Status Unknown
3
Univ of Colorado Health Sciences Ctr
Denver, Colorado, United States, 80262
Status Unknown
4
Howard Univ
Washington D.C., District of Columbia, United States, 20059
Status Unknown
5
Univ of Miami School of Medicine
Miami, Florida, United States, 331361013
Status Unknown
6
Queens Med Ctr
Honolulu, Hawaii, United States, 96816
Status Unknown
7
Univ of Hawaii
Honolulu, Hawaii, United States, 96816
Status Unknown
8
Johns Hopkins Hosp
Baltimore, Maryland, United States, 21287
Status Unknown
9
Harvard (Massachusetts Gen Hosp)
Boston, Massachusetts, United States, 02114
Status Unknown
10
St Louis Regional Hosp / St Louis Regional Med Ctr
St Louis, Missouri, United States, 63112
Status Unknown
11
Univ of Nebraska Med Ctr
Omaha, Nebraska, United States, 681985130
Status Unknown
12
Bellevue Hosp / New York Univ Med Ctr
New York, New York, United States, 10016
Status Unknown
13
Univ of North Carolina
Chapel Hill, North Carolina, United States, 275997215
Status Unknown
14
Julio Arroyo
West Columbia, South Carolina, United States, 29169
Status Unknown
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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