Rapid Oral Test for Therapeutic Response in HIV/AIDS Patients
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- AIDS/HIV PROBLEM
- Sponsor
- Gaia Medical Institute
- Enrollment
- 100
- Locations
- 1
- Status
- Completed
- Last Updated
- 8 years ago
Overview
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.
Investigators
Eligibility 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
- •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
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
Outcomes
Primary Outcomes
Not specified