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Rapid Oral Test for Therapeutic Response in HIV/AIDS Patients
The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2012 by Gaia Medical Institute.
Recruitment status was: Recruiting
Recruitment status was: Recruiting
Sponsor:
Gaia Medical Institute
Collaborator:
AIDS Healthcare Foundation
Information provided by (Responsible Party):
Gaia Medical Institute
ClinicalTrials.gov Identifier:
NCT01507142
First received: January 6, 2012
Last updated: July 16, 2012
Last verified: July 2012
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Purpose
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.
| Condition |
|---|
| AIDS/HIV PROBLEM |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Cross-Sectional |
| Official Title: | Rapid Oral Test for Therapeutic Response in HIV/AIDS Patients |
Resource links provided by NLM:
Further study details as provided by Gaia Medical Institute:
Biospecimen Retention: Samples Without DNA
Saliva
| Estimated Enrollment: | 100 |
| Study Start Date: | October 2011 |
| Estimated Study Completion Date: | October 2013 |
| Estimated Primary Completion Date: | September 2012 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
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
|
Eligibility| Ages Eligible for Study: | Child, Adult, Senior |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
HIV-positive, or HIV-negative and Hepatitis-positive adult participants
Criteria
Inclusion Criteria:
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
- 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
Exclusion Criteria:
- 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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01507142
Please refer to this study by its ClinicalTrials.gov identifier: NCT01507142
Contacts
| Contact: Gerald Ramirez | gerald.ramirez@aidshealth.org |
Locations
| United States, California | |
| AIDS Healthcare Foundation | Recruiting |
| Los Angeles, California, United States, 90211 | |
| Contact: Gerald Ramirez 323-662-0492 ext 15406 gerald.ramirez@aidshealth.org | |
| Principal Investigator: Wayne Chen, MD | |
Sponsors and Collaborators
Gaia Medical Institute
AIDS Healthcare Foundation
Investigators
| Principal Investigator: | Wayne Chen, M.D. | AIDS Healthcare Foundation |
| Principal Investigator: | Sarka Southern, Ph.D. | Gaia Medical Institute |
More Information
| Responsible Party: | Gaia Medical Institute |
| ClinicalTrials.gov Identifier: | NCT01507142 History of Changes |
| Other Study ID Numbers: |
GAIA-AIDS-001 |
| Study First Received: | January 6, 2012 |
| Last Updated: | July 16, 2012 |
Keywords provided by Gaia Medical Institute:
|
saliva diagnostics HIV AIDS |
ClinicalTrials.gov processed this record on July 19, 2017