AIDS/HIV PROBLEMNCT01507142
Rapid Oral Test for Therapeutic Response in HIV/AIDS Patients
An observational study of AIDS/HIV PROBLEM, run by Gaia Medical Institute at 1 site in United States.
Trial summary
This study has been designed to evaluate a new oral test for therapeutic monitoring of HIV/AIDS patients that are receiving the combination Anti-Retroviral Therapy (cART). The test will measure saliva-based Stress Response Profiling(SRP) biomarkers using laboratory assays. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- AIDS/HIV PROBLEM
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2011to Oct 2013
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: HIV-positive, or HIV-negative and Hepatitis-positive adult participants
Who may be able to join
- Group 1, cART-unresponsive
- Documented HIV-positive before obtaining AIDS diagnosis
- cART for 18 months or longer
- consistent lab tests in previous 3-6 months: < or equal to 200 CD4 T cells/mm3, viral load >5000 HIV RNA copies/ml
- Group 2, cART-responsive
- Documented HIV-positive before obtaining AIDS diagnosis
Show all 16Show fewer
- cART for 18 months or longer
- consistent lab tests in previous 3-6 months: > or equal to 350 CD4 T cells/mm3, viral load < or equal to 50 HIV RNA copies/ml
- Group 3, acute/early HIV
- Acute HIV:
- Signs and symptoms of acute retroviral syndrome in a person with either a negative or evolving antibody response (western blot or ELISA) in presence of a positive HIV p24gag antigen or HIV-1 proviral DNA PCR or positive HIV-1 RNA
- Early HIV:
- A positive antibody response (western blot or ELISA) with a documented negative serological test or plasma HIV-1 RNA within the past 12 months or a positive ELISA and a negative de-tuned ELISA within 30 days of a positive ELISA specimen in an untreated person with no clinical or immunological evidence of advanced HIV disease (CD4 count >200 cells/mm3 or >14%)
- Group 4, HIV-negative Hepatitis-positive
- HIV test negative (western blot, ELISA or viral load)
- Positive Hepatitis B surface antigen and detectable hepatitis B viral load (HCV B RNA), treated or not OR Positive Hepatitis C antibodies and detectable hepatitis C viral load (HCV C RNA), treated or not
Who cannot join
- Pregnant or lactating women
- Non-adherent patients
- Any conditions which will affect saliva production: e.g. Sjogren's syndrome or chronic mouth dryness
- Cytotoxic chemotherapy, interferon treatment, or radiation therapy within the preceding 3 weeks
- Active alcohol or substance abuse (narcotics or other controlled substances) within 6 months prior to the saliva sampling
- Significant psychiatric illness that in the opinion of the principle investigator might interfere with making an informed decision
- Incapable to give informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
AIDS Healthcare Foundation
Los Angeles, California, 90211
About this study
This study has been designed to evaluate a new oral test for therapeutic monitoring of HIV/AIDS patients that are receiving the combination Anti-Retroviral Therapy (cART). The test will measure saliva-based Stress Response Profiling(SRP) biomarkers using laboratory assays. Results of the test will show if HIV/AIDS patients successfully responded to cART. Preliminary studies showed that SRP biomarkers were strongly increased in cART-unresponsive AIDS patients. However, the diagnostic accuracy of the oral test, patients will be recruited to donate saliva: AIDS patients responsive or unresponsive to cART, and controls (acute or early HIV patients, and HIV-negative patients with hepatitis).
The saliva samples will be used to measure SRP biomarker concentrations. Results will show whether the biomarker measurements provide accurate and specific diagnostics for ART response.
- Conditions
- AIDS/HIV PROBLEM
- Keywords
- saliva, diagnostics, HIV, AIDS
- Medical subject headings
- Acquired Immunodeficiency Syndrome
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 |
|---|---|---|
| cART-unresponsive AIDS | HIV-positive, AIDS diagnosis, cART for >18 months, <200 CD4 Tcells/mm3 and Viral Load >5000 copies/ml | |
| cART-responsive AIDS | HIV-positive, AIDS diagnosis, cART for >18 months, >350 CD4 Tcells/mm3 and Viral Load<50 copies/ml | |
| Acute or early HIV infection | Acute HIV: Acute retroviral syndrome, Negative or positive HIV antibody, Positive HIV p24gag, viral load or NAAT / Early HIV: HIV antibody and viral load positive currently, negative in last 12 months, No clinical or immunological evidence of advanced HIV disease | |
| HIV-negative Hepatitis B | Negative HIV antibody and viral load, Positive HBV antibody, Positive or Negative HBV surface antigen, Negative or Positive HBV viral load |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2012 (estimated)
- Study startOct 2011
- Primary completionSep 2012
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AIDS/HIV PROBLEMStudies 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-control
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gaia Medical Institute
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- AIDS Healthcare Foundation
- Responsible party
- Sponsor
- Investigators
- Wayne Chen, M.D., Principal investigator, AIDS Healthcare FoundationSarka Southern, Ph.D., Principal investigator, Gaia Medical Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01507142
- Sponsor's protocol ID
- GAIA-AIDS-001
- Status last verified
- Feb 2018
- First submitted
- 6 Jan 2012
- Last updated
- 15 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rapid Oral Test for Therapeutic Response in HIV/AIDS Patients
- ClinicalTrials.gov ID
- NCT01507142
- Acronym / sponsor ID
- GAIA-AIDS-001
- Conditions
- AIDS/HIV PROBLEM
- Keywords
- saliva, diagnostics, HIV, AIDS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Gaia Medical InstituteIndustry (pharma, biotech, devices)
- Collaborators
- AIDS Healthcare Foundation
- Study start
- Oct 2011 (actual)
- Primary completion
- Sep 2012 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 10 Jan 2012 (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.
This study has been designed to evaluate a new oral test for therapeutic monitoring of HIV/AIDS patients that are receiving the combination Anti-Retroviral Therapy (cART). The test will measure saliva-based Stress Response Profiling(SRP) biomarkers using laboratory assays. Results of the test will show if HIV/AIDS patients successfully responded to cART. Preliminary studies showed that SRP biomarkers were strongly increased in cART-unresponsive AIDS patients. However, the diagnostic accuracy of the oral test, patients will be recruited to donate saliva: AIDS patients responsive or unresponsive to cART, and controls (acute or early HIV patients, and HIV-negative patients with hepatitis).
The saliva samples will be used to measure SRP biomarker concentrations. Results will show whether the biomarker measurements provide accurate and specific diagnostics for ART response.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| cART-unresponsive AIDS | – | –HIV-positive, AIDS diagnosis, cART for >18 months, <200 CD4 Tcells/mm3 and Viral Load >5000 copies/ml |
| cART-responsive AIDS | – | –HIV-positive, AIDS diagnosis, cART for >18 months, >350 CD4 Tcells/mm3 and Viral Load<50 copies/ml |
| Acute or early HIV infection | – | –Acute HIV: Acute retroviral syndrome, Negative or positive HIV antibody, Positive HIV p24gag, viral load or NAAT / Early HIV: HIV antibody and viral load positive currently, negative in last 12 months, No clinical or immunological evidence of advanced HIV disease |
| HIV-negative Hepatitis B | – | –Negative HIV antibody and viral load, Positive HBV antibody, Positive or Negative HBV surface antigen, Negative or Positive HBV viral load |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- HIV-positive, or HIV-negative and Hepatitis-positive adult participants
Key inclusion criteria (16 listed)
- Group 1, cART-unresponsive
- Documented HIV-positive before obtaining AIDS diagnosis
- cART for 18 months or longer
- consistent lab tests in previous 3-6 months: < or equal to 200 CD4 T cells/mm3, viral load >5000 HIV RNA copies/ml
- Group 2, cART-responsive
Key exclusion criteria (7 listed)
- Pregnant or lactating women
- Non-adherent patients
- Any conditions which will affect saliva production: e.g. Sjogren's syndrome or chronic mouth dryness
- Cytotoxic chemotherapy, interferon treatment, or radiation therapy within the preceding 3 weeks
- Active alcohol or substance abuse (narcotics or other controlled substances) within 6 months prior to the saliva sampling
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
Not reported in the source record.
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 15 Feb 2018.
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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.
Wayne Chen, M.D. principal investigator
AIDS Healthcare Foundation
Sarka Southern, Ph.D. principal investigator
Gaia Medical Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of AIDS/HIV PROBLEM, run by Gaia Medical Institute at 1 site in United States.
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 16 inclusion and 7 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 15 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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.
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 15 Feb 2018.