NCT00959413

Brief Summary

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
328

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2009

Typical duration for all trials

Geographic Reach
2 countries

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 12, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 14, 2009

Completed
18 days until next milestone

Study Start

First participant enrolled

September 1, 2009

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

March 18, 2015

Status Verified

March 1, 2015

Enrollment Period

3 years

First QC Date

August 12, 2009

Last Update Submit

March 17, 2015

Conditions

HIV Infections

Outcome Measures

Primary Outcomes (4)

  • Presumptive clinical diagnoses of oral mucosal diseases

    At study visit

  • HIV-1 viral load in throat wash.

    At study visit

  • HIV-1 viral load in plasma

    At study visit

  • Candida CFU level as measured in CFU/mL of throat wash solution.

    At study visit

Secondary Outcomes (7)

  • Prevalence of HIV-1 related oral mucosal lesions

    At study visit

  • KSHV DNA viral load in throat wash

    At study visit

  • CMV DNA load in throat wash

    At study visit

  • Oral candidal genotypes

    At study visit

  • Antifungal resistance as measured by MIC

    At study visit

  • +2 more secondary outcomes

Study Arms (4)

A

Participants who have a CD4 count of 200 cells/mm3 or less and a viral load greater than 1,000 copies/ml

B

Participants who have a CD4 count of 200 cells/mm3 or less and a viral load of 1,000 copies/ml or less

C

Participants will have a CD4 count that is greater than 200 cells/mm3 and a viral load that is greater than 1,000 copies/ml

D

Participants will have a CD4 count that is greater than 200 cells/mm3 and a viral load that is 1,000 copies/ml or less

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

HIV-infected individuals

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Ucsf Aids Crs (801)

San Francisco, California, 94110, United States

Location

The Ponce de Leon Ctr. CRS (5802)

Atlanta, Georgia, 30308, United States

Location

NY Univ. HIV/AIDS CRS (401)

New York, New York, 10016, United States

Location

Unc Aids Crs (3201)

Chapel Hill, North Carolina, 27514, United States

Location

Case CRS (2501)

Cleveland, Ohio, 44106, United States

Location

Les Centres GHESKIO CRS (30022)

Bicentenaire, Port-au-Prince, HT-6110, Haiti

Location

Biospecimen

Retention: SAMPLES WITH DNA

Samples of saliva and blood will be kept

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Judith A Aberg, MD

    NYU Langone Health

    STUDY CHAIR

  • Caroline Shiboski, DDS, MPH, PhD

    Department of Orofacial Sciences, University of California, San Francisco

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 12, 2009

First Posted

August 14, 2009

Study Start

September 1, 2009

Primary Completion

September 1, 2012

Study Completion

September 1, 2012

Last Updated

March 18, 2015

Record last verified: 2015-03

Locations

US(5)HA(1)