Rapid Oral Test for Therapeutic Response in HIV/AIDS Patients

AIDS/HIV PROBLEM Clinical Trial

Official title:

Rapid Oral Test for Therapeutic Response in HIV/AIDS Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01507142
• Other study ID #: GAIA-AIDS-001
• Status: Completed
• Phase: N/A
• First received: January 6, 2012
• Last updated: February 13, 2018
• Start date: October 2011
• Est. completion date: October 2013

Study information

• Verified date: February 2018
• Source: Gaia Medical Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: October 2013
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• AIDS/HIV PROBLEM

Locations

Country	Name	City	State
United States	AIDS Healthcare Foundation	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
Gaia Medical Institute	AIDS Healthcare Foundation

Country where clinical trial is conducted

United States,