Rapid Oral Test for Therapeutic Response in HIV/AIDS Patients

Sponsor

Gaia Medical Institute (Industry)

Overall Status

Completed

CT.gov ID

NCT01507142

Collaborator

AIDS Healthcare Foundation (Other)

100

Enrollment

Location

Actual Duration (Months)

4.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
AIDS/HIV PROBLEM

Study Design

Study Type:

Observational

Actual Enrollment :

100 participants

Observational Model:

Case-Control

Time Perspective:

Cross-Sectional

Official Title:

Rapid Oral Test for Therapeutic Response in HIV/AIDS Patients

Actual Study Start Date :

Oct 1, 2011

Actual Primary Completion Date :

Sep 1, 2012

Actual Study Completion Date :

Oct 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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