Rapid Oral Test for Therapeutic Response in HIV/AIDS Patients

NCT01507142 | Completed

• 1 other identifier: GAIA-AIDS-001
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

AIDS/HIV PROBLEM

Keywords

saliva; diagnostics; HIV; AIDS

Study Arms (4)

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

HIV-positive, or HIV-negative and Hepatitis-positive adult participants

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Gaia Medical Institute: lead
• AIDS Healthcare Foundation: collaborator

Study Sites (1)

AIDS Healthcare Foundation

Los Angeles, California, 90211, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Saliva

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Wayne Chen, M.D.

  AIDS Healthcare Foundation

  PRINCIPAL INVESTIGATOR

• Sarka Southern, Ph.D.

  Gaia Medical Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2012
• First Posted: January 10, 2012
• Study Start: October 1, 2011
• Primary Completion: September 1, 2012
• Study Completion: October 1, 2013
• Last Updated: February 15, 2018

Record last verified: 2018-02

Locations

US (1)