The Effects of Illnesses on HIV Levels in the Body

The Impact of Intercurrent Illness on HIV Viral Load

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.

Study Overview

• Status: Completed
• Conditions: HIV Infections

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.

• Study Type: Observational
• Enrollment: 26

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Collaborators and Investigators

• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Investigators: Study Chair: Currier J

Study record dates

Study Registration Dates

• First Submitted: November 2, 1999
• First Submitted That Met QC Criteria: August 30, 2001
• First Posted (Estimate): August 31, 2001

Study Record Updates

• Last Update Posted (Estimate): June 24, 2005
• Last Update Submitted That Met QC Criteria: June 23, 2005
• Last Verified: April 1, 1999

More Information

Terms related to this study

• Keywords: HIV-1; RNA, Viral; Viral Load; Fever; Antiviral Agents; CD4 Lymphocyte Count; AIDS-Related Opportunistic Infections; Polymerase Chain Reaction
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; HIV Infections
• Other Study ID Numbers: ACTG 891