Rapid Oral Test for Therapeutic Response in HIV/AIDS Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-10-31

Study Completion Date

2013-10-31

Brief Summary

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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.

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Detailed Description

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Conditions

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AIDS/HIV PROBLEM

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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cART-unresponsive AIDS

HIV-positive, AIDS diagnosis, cART for \>18 months, \<200 CD4 Tcells/mm3 and Viral Load \>5000 copies/ml

No interventions assigned to this group

cART-responsive AIDS

HIV-positive, AIDS diagnosis, cART for \>18 months, \>350 CD4 Tcells/mm3 and Viral Load\<50 copies/ml

No interventions assigned to this group

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

No interventions assigned to this group

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

No interventions assigned to this group

Eligibility Criteria

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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

Eligible Sex

ALL

Accepts Healthy Volunteers

No