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Rapid Oral Test for Therapeutic Response in HIV/AIDS Patients

NCT01507142 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2018-02-15

No results posted yet for this study

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.

Conditions

  • AIDS/HIV PROBLEM

Sponsors & Collaborators

  • AIDS Healthcare Foundation

    collaborator OTHER

  • Gaia Medical Institute

    lead INDUSTRY

Principal Investigators

  • Wayne Chen, M.D. · AIDS Healthcare Foundation

  • Sarka Southern, Ph.D. · Gaia Medical Institute

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2012-09-30
Completion
2013-10-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01507142 on ClinicalTrials.gov