The Effects of Illnesses on HIV Levels in the Body
The Impact of Intercurrent Illness on HIV Viral Load
1 other identifier
observational
26
1 country
14
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedJune 24, 2005
April 1, 1999
November 2, 1999
June 23, 2005
Conditions
Keywords
Eligibility Criteria
You may qualify if:
- 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:
- , 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (14)
Univ of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
Univ of California / San Diego Treatment Ctr
San Diego, California, 921036325, United States
Univ of Colorado Health Sciences Ctr
Denver, Colorado, 80262, United States
Howard Univ
Washington D.C., District of Columbia, 20059, United States
Univ of Miami School of Medicine
Miami, Florida, 331361013, United States
Queens Med Ctr
Honolulu, Hawaii, 96816, United States
Univ of Hawaii
Honolulu, Hawaii, 96816, United States
Johns Hopkins Hosp
Baltimore, Maryland, 21287, United States
Harvard (Massachusetts Gen Hosp)
Boston, Massachusetts, 02114, United States
St Louis Regional Hosp / St Louis Regional Med Ctr
St Louis, Missouri, 63112, United States
Univ of Nebraska Med Ctr
Omaha, Nebraska, 681985130, United States
Bellevue Hosp / New York Univ Med Ctr
New York, New York, 10016, United States
Univ of North Carolina
Chapel Hill, North Carolina, 275997215, United States
Julio Arroyo
West Columbia, South Carolina, 29169, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Sha B
- STUDY CHAIR
Currier J
Study Design
- Study Type
- observational
- Observational Model
- NATURAL HISTORY
- Time Perspective
- OTHER
- Sponsor Type
- NIH
Study Record Dates
First Submitted
November 2, 1999
First Posted
August 31, 2001
Last Updated
June 24, 2005
Record last verified: 1999-04