Completed

Impact of Intercurrent Illness on HIV Viral Load Changes

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What is being collected

Data Collection

Who is being recruted

Blood-Borne Infections+17

+ Urogenital Diseases

+ Genital Diseases

Over 13 Years
+10 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Natural History

Observing the progression of a disease in untreated individuals in order to understand its typical course and outcomes.
Observational
See protocol details

Summary

Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

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.

Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

26 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Natural History

These studies observe how a disease progresses over time without active treatment. They help researchers understand how conditions typically develop, change, and impact quality of life.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 13 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Blood-Borne InfectionsUrogenital DiseasesGenital DiseasesBody Temperature ChangesCommunicable DiseasesImmunologic Deficiency SyndromesImmune System DiseasesInfectionsOpportunistic InfectionsRetroviridae InfectionsRNA Virus InfectionsSexually Transmitted DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsVirus DiseasesSexually Transmitted Diseases, ViralLentivirus InfectionsFeverHIV InfectionsAIDS-Related Opportunistic Infections

Criteria

7 inclusion criteria required to participate
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)

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

Documented temperature above 101degrees F on the day of the screening

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

Show More Criteria

3 exclusion criteria prevent from participating
Change in antiretroviral therapy combination within 8 weeks prior to study entry

Interruption of current antiretroviral therapy due to the onset of acute intercurrent illness

Patients receiving IL-2

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 14 locations

Univ of Alabama at Birmingham

Birmingham, United StatesOpen Univ of Alabama at Birmingham in Google Maps

Univ of California / San Diego Treatment Ctr

San Diego, United States

Univ of Colorado Health Sciences Ctr

Denver, United States

Howard Univ

Washington D.C., United States
Completed14 Study Centers