NCT01507142

Rapid Oral Test for Therapeutic Response in HIV/AIDS Patients

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 100 (actual)
• Sponsor: Gaia Medical Institute · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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

Timeline

• Start date: 2011-10-01
• Primary completion: 2012-09-01
• Completion: 2013-10-01
• First posted: 2012-01-10
• Last updated: 2018-02-15

Locations

1 site across 1 country: United States