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Rapid Oral Test for Therapeutic Response in HIV/AIDS Patients

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ClinicalTrials.gov Identifier: NCT01507142
Recruitment Status : Completed
First Posted : January 10, 2012
Last Update Posted : February 15, 2018
Sponsor:
Collaborator:
AIDS Healthcare Foundation
Information provided by (Responsible Party):
Gaia Medical Institute

Study Description
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief 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. 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 or disease
AIDS/HIV PROBLEM

Study Design
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Study Type : Observational
Actual Enrollment : 100 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Rapid Oral Test for Therapeutic Response in HIV/AIDS Patients
Actual Study Start Date : October 2011
Actual Primary Completion Date : September 2012
Actual Study Completion Date : October 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Groups and Cohorts
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort
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


Outcome Measures
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Biospecimen Retention:   Samples Without DNA
Saliva

Eligibility Criteria
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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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
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01507142


Locations
United States, California
AIDS Healthcare Foundation
Los Angeles, California, United States, 90211
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
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Gaia Medical Institute
ClinicalTrials.gov Identifier: NCT01507142     History of Changes
Other Study ID Numbers: GAIA-AIDS-001
First Posted: January 10, 2012    Key Record Dates
Last Update Posted: February 15, 2018
Last Verified: February 2018

Keywords provided by Gaia Medical Institute:
saliva
diagnostics
HIV
AIDS