Search / Trial NCT00000900

The Effects of Illnesses on HIV Levels in the Body

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001

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Trial Information

Current as of February 21, 2024

Completed

Keywords

Aids Related Opportunistic Infections Hiv 1 Antiviral Agents Cd4 Lymphocyte Count Polymerase Chain Reaction Rna, Viral Fever Viral Load

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 ...

Gender

All

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.

Attachments

readout_NCT00000900_2024-02-21.pdf

4.5 MB

NCT00000900_study_protocol.pdf

4.5 MB

About company

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

Jennifer Cobb

Immunology at National Institute of Allergy and Infectious Diseases (NIAID)

Locations

Birmingham, Alabama, United States

West Columbia, South Carolina, United States

San Diego, California, United States

New York, New York, United States

Chapel Hill, North Carolina, United States

Washington, District Of Columbia, United States

Miami, Florida, United States

Honolulu, Hawaii, United States

Honolulu, Hawaii, United States

Baltimore, Maryland, United States

Omaha, Nebraska, United States

Denver, Colorado, United States

Boston, Massachusetts, United States

St. Louis, Missouri, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Reviews (48)

4.6

All reviews come from applied patients

5 stars
41
4 stars
6
3 stars
2
2 stars
0
1 stars
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Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Michael Foster
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Dries Vincent
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

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