The Effects of Illnesses on HIV Levels in the Body

This study has been completed.
Sponsor:
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00000900
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: April 1999
  Purpose

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.


Condition
HIV Infections

Study Type: Observational
Study Design: Observational Model: Natural History
Time Perspective: Longitudinal
Official Title: The Impact of Intercurrent Illness on HIV Viral Load

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Estimated Enrollment: 26
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.

  Eligibility

Ages Eligible for Study:   13 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00000900

Locations
United States, Alabama
Univ of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
United States, California
Univ of California / San Diego Treatment Ctr
San Diego, California, United States, 921036325
United States, Colorado
Univ of Colorado Health Sciences Ctr
Denver, Colorado, United States, 80262
United States, District of Columbia
Howard Univ
Washington, District of Columbia, United States, 20059
United States, Florida
Univ of Miami School of Medicine
Miami, Florida, United States, 331361013
United States, Hawaii
Queens Med Ctr
Honolulu, Hawaii, United States, 96816
Univ of Hawaii
Honolulu, Hawaii, United States, 96816
United States, Maryland
Johns Hopkins Hosp
Baltimore, Maryland, United States, 21287
United States, Massachusetts
Harvard (Massachusetts Gen Hosp)
Boston, Massachusetts, United States, 02114
United States, Missouri
St Louis Regional Hosp / St Louis Regional Med Ctr
St. Louis, Missouri, United States, 63112
United States, Nebraska
Univ of Nebraska Med Ctr
Omaha, Nebraska, United States, 681985130
United States, New York
Bellevue Hosp / New York Univ Med Ctr
New York, New York, United States, 10016
United States, North Carolina
Univ of North Carolina
Chapel Hill, North Carolina, United States, 275997215
United States, South Carolina
Julio Arroyo
West Columbia, South Carolina, United States, 29169
Sponsors and Collaborators
Investigators
Study Chair: Sha B
Study Chair: Currier J
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00000900     History of Changes
Other Study ID Numbers: ACTG 891
Study First Received: November 2, 1999
Last Updated: June 23, 2005
Health Authority: United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
AIDS-Related Opportunistic Infections
HIV-1
Antiviral Agents
CD4 Lymphocyte Count
Polymerase Chain Reaction
RNA, Viral
Fever
Viral Load

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on April 14, 2014