HIV InfectionsNCT00959413
Assessing HIV-Related Oral Mucosal Disease and Using Saliva to Measure Viral Load
An observational study of HIV Infections, run by Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections at 6 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections
- How many people
- 328 participants
- Where
- 6 sitesin 2 countries
- Study dates
- Sep 2009to Sep 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: HIV-infected individuals
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
United States5 sites
The Ponce de Leon Ctr. CRS (5802)
Atlanta, Georgia, 30308
Unc Aids Crs (3201)
Chapel Hill, North Carolina, 27514
Case CRS (2501)
Cleveland, Ohio, 44106
NY Univ. HIV/AIDS CRS (401)
New York, New York, 10016
Ucsf Aids Crs (801)
San Francisco, California, 94110
Haiti1 site
Les Centres GHESKIO CRS (30022)
Bicentenaire, Port-au-Prince, HT-6110
About this study
Official title: Assessment of HIV-1-Related Oral Mucosal Disease and Use of Saliva in Measuring HIV-1 Viral Load
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.
Read the detailed description
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.
- Conditions
- HIV Infections
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presumptive clinical diagnoses of oral mucosal diseases
Measured: At study visit
HIV-1 viral load in throat wash.
Measured: At study visit
HIV-1 viral load in plasma
Measured: At study visit
Candida CFU level as measured in CFU/mL of throat wash solution.
Measured: At study visit
Secondary outcomes (7)
Prevalence of HIV-1 related oral mucosal lesions
Measured: At study visit
KSHV DNA viral load in throat wash
Measured: At study visit
CMV DNA load in throat wash
Measured: At study visit
Oral candidal genotypes
Measured: At study visit
Antifungal resistance as measured by MIC
Measured: At study visit
HSV-1 DNA viral load in throat wash
Measured: At study visit
EBV DNA viral load in throat wash
Measured: At study visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2009 (estimated)
- Study startSep 2009
- Primary completionSep 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 328 participants (actual)
Sponsor and investigators
- Lead sponsor
- Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Judith A Aberg, MD, Study chair, NYU Langone HealthCaroline Shiboski, DDS, MPH, PhD, Study chair, Department of Orofacial Sciences, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00959413
- Sponsor's protocol ID
- ACTG A5254
- Other IDs
- 1U01AI068636
- Status last verified
- Mar 2015
- First submitted
- 12 Aug 2009
- Last updated
- 18 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of HIV-1-Related Oral Mucosal Disease and Use of Saliva in Measuring HIV-1 Viral Load
- ClinicalTrials.gov ID
- NCT00959413
- Acronym / sponsor ID
- ACTG A5254
- Conditions
- HIV Infections
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 328 participants (actual)
- Lead sponsor
- Advancing Clinical Therapeutics Globally for HIV/AIDS and Other InfectionsResearch network
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- Sep 2009
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 14 Aug 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- HIV-infected individuals
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Presumptive clinical diagnoses of oral mucosal diseases
Time frame: At study visit
HIV-1 viral load in throat wash.
Time frame: At study visit
HIV-1 viral load in plasma
Time frame: At study visit
Candida CFU level as measured in CFU/mL of throat wash solution.
Time frame: At study visit
7 secondary outcomes
Prevalence of HIV-1 related oral mucosal lesions
Time frame: At study visit
KSHV DNA viral load in throat wash
Time frame: At study visit
CMV DNA load in throat wash
Time frame: At study visit
Oral candidal genotypes
Time frame: At study visit
Antifungal resistance as measured by MIC
Time frame: At study visit
HSV-1 DNA viral load in throat wash
Time frame: At study visit
EBV DNA viral load in throat wash
Time frame: At study visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Judith A Aberg, MD study chair
NYU Langone Health
Caroline Shiboski, DDS, MPH, PhD study chair
Department of Orofacial Sciences, University of California, San Francisco
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infections, run by Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections at 6 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States, Haiti. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presumptive clinical diagnoses of oral mucosal diseases (time frame: At study visit). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2015.