Rapid Oral Test for Therapeutic Response in HIV/AIDS Patients

February 13, 2018 updated by: Gaia Medical Institute

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 Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90211
        • AIDS Healthcare Foundation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

HIV-positive, or HIV-negative and Hepatitis-positive adult participants

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gaia Medical Institute

Collaborators

AIDS Healthcare Foundation

Investigators

  • Principal Investigator: Wayne Chen, M.D., AIDS Healthcare Foundation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2011

Primary Completion (Actual)

September 1, 2012

Study Completion (Actual)

October 1, 2013

Study Registration Dates

First Submitted

January 6, 2012

First Submitted That Met QC Criteria

January 6, 2012

First Posted (Estimate)

January 10, 2012

Study Record Updates

Last Update Posted (Actual)

February 15, 2018

Last Update Submitted That Met QC Criteria

February 13, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GAIA-AIDS-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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