skip navigation

Skip Nav

Ensayos clínicos

Ensayos clínicos

Assessing HIV-Related Oral Mucosal Disease and Using Saliva to Measure Viral Load

Patrocinador(es) del estudio: AIDS Clinical Trials Group
Números de identificación: NCT00959413, ACTG A5254
  • Inscripciones abiertas

Propósito del estudio

The mouth may play an important part in monitoring HIV progression. Mucosal lesions of the mouth are often the first sign of infection and their development in already diagnosed individuals indicates disease progression. In addition, saliva may provide a non-invasive way to track viral load. The purpose of this study is to establish standardized practices for examining the mouth and identifying oral mucosal lesions as well as to establish a correlation of viral load with HIV particles found in saliva.

Afección:
Infecciones por el VIH

Detalles del estudio

The oral cavity has been found to play an important role in monitoring the progression of

HIV infection. The occurrence of specific lesions, mainly oral candidiasis and hairy

leukoplakia, is strongly associated with a low CD4 cell count and a higher plasma viral

load. Furthermore, even though the prevalence of specific oral lesions like candidiasis,

hairy leukoplakia, and Kaposi sarcoma (KS) has been found to be lower among patients on

highly active antiretroviral therapy (HAART), other oral lesions such as warts have been

found to be more prevalent in this population. In addition, saliva has been shown to harbor

viral particles, antibodies, and cytokines, and may represent an easily and noninvasively

collected specimen for various diagnostic assays, including early diagnosis of HIV. The

purpose of this study is to establish a set of standardized practices for examining and

diagnosing oral mucosal lesions and to establish a correlation between the amount of HIV

found in the saliva with viral load.



Participants in this study will attend only one screening visit and study visit and will be

assigned to one of four groups based on viral load and CD4 count. Group A will consist of

participants who have a CD4 count of 200 cells/mm3 or less and a viral load greater than

1000 copies/ml. Group B will be made up of participants who have a CD4 count of 200

cells/mm3 or less and a viral load of 1000 copies/ml or less. Group C participants will have

a CD4 count that is greater than 200 cells/mm3 and a viral load that is greater than 1000

copies/ml. Participants making up Group D will have a CD4 count that is greater than 200

cells/mm3 and a viral load that is 1000 copies/ml or less.



All participants will have a medical history taken and blood collected as well as performing

a throat wash collection and whole saliva collection. In addition, two oral exams will be

performed at the study visit.The oral cavity has been found to play an important role in monitoring the progression of

HIV infection. The occurrence of specific lesions, mainly oral candidiasis and hairy

leukoplakia, is strongly associated with a low CD4 cell count and a higher plasma viral

load. Furthermore, even though the prevalence of specific oral lesions like candidiasis,

hairy leukoplakia, and Kaposi sarcoma (KS) has been found to be lower among patients on

highly active antiretroviral therapy (HAART), other oral lesions such as warts have been

found to be more prevalent in this population. In addition, saliva has been shown to harbor

viral particles, antibodies, and cytokines, and may represent an easily and noninvasively

collected specimen for various diagnostic assays, including early diagnosis of HIV. The

purpose of this study is to establish a set of standardized practices for examining and

diagnosing oral mucosal lesions and to establish a correlation between the amount of HIV

found in the saliva with viral load.



Participants in this study will attend only one screening visit and study visit and will be

assigned to one of four groups based on viral load and CD4 count. Group A will consist of

participants who have a CD4 count of 200 cells/mm3 or less and a viral load greater than

1000 copies/ml. Group B will be made up of participants who have a CD4 count of 200

cells/mm3 or less and a viral load of 1000 copies/ml or less. Group C participants will have

a CD4 count that is greater than 200 cells/mm3 and a viral load that is greater than 1000

copies/ml. Participants making up Group D will have a CD4 count that is greater than 200

cells/mm3 and a viral load that is 1000 copies/ml or less.



All participants will have a medical history taken and blood collected as well as performing

a throat wash collection and whole saliva collection. In addition, two oral exams will be

performed at the study visit.

Criterios de inclusión

    :
    • HIV-1 infection, as documented by any rapid test or licensed ELISA test kit and
    confirmed by Western blot, HIV-1 culture, HIV-1 antigen, plasma HIV-1 RNA, or a second antibody test by a method other than ELISA
    • CD4+ cell count obtained = 60 days prior to study entry
    • Plasma HIV-1 RNA levels obtained = 60 days prior to study entry
    • If receiving ART, participants must be on same ART regimen for at least 12 weeks
    immediately prior to study entry
    • If study participants are not currently on an ART regimen, they must have not
    discontinued ART therapy within 30 days prior to study entry
    • Ability and willingness of study participant or legal guardian/representative to
    provide informed consent

Criterios de exclusión

    :
    • History of head and/or neck radiation secondary to malignancy
    • History of any HIV-1 therapeutic related vaccines
    • Use of any systemic anti-fungal in the 90 days prior to entry

Centros de estudio/contactos

California

    Ucsf Aids Crs (801), San Francisco, California, 94110, United States

Georgia

    The Ponce de Leon Ctr. CRS (5802), Atlanta, Georgia, 30308, United States

New York

    NY Univ. HIV/AIDS CRS (401), New York, New York, 10016, United States

North Carolina

    Unc Aids Crs (3201), Chapel Hill, North Carolina, 27514, United States

Ohio

    Case CRS (2501), Cleveland, Ohio, 44106, United States

Port-au-Prince

    Les Centres GHESKIO CRS (30022), Bicentenaire, Port-au-Prince, HT-6110, Haiti

Actualizado: 8 de enero del 2010

Volver arriba