Status:
COMPLETED
The Effects of Illnesses on HIV Levels in the Body
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
HIV Infections
Eligibility:
All Genders
13+ years
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 diagnos...
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 undetectabl...
Eligibility Criteria
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.
Key Trial Info
Start Date :
Trial Type :
OBSERVATIONAL
End Date :
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT00000900
Last Update
June 24 2005
Active Locations (14)
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1
Univ of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
2
Univ of California / San Diego Treatment Ctr
San Diego, California, United States, 921036325
3
Univ of Colorado Health Sciences Ctr
Denver, Colorado, United States, 80262
4
Howard Univ
Washington D.C., District of Columbia, United States, 20059