Rapid Oral Test for Therapeutic Response in HIV/AIDS Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2012 by Gaia Medical Institute.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
AIDS Healthcare Foundation
Information provided by (Responsible Party):
Gaia Medical Institute
ClinicalTrials.gov Identifier:
NCT01507142
First received: January 6, 2012
Last updated: July 16, 2012
Last verified: July 2012

January 6, 2012
July 16, 2012
October 2011
September 2012   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT01507142 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Rapid Oral Test for Therapeutic Response in HIV/AIDS Patients
Rapid Oral Test for Therapeutic Response in HIV/AIDS Patients

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.

Not Provided
Observational
Observational Model: Case Control
Time Perspective: Cross-Sectional
Not Provided
Retention:   Samples Without DNA
Description:

Saliva

Non-Probability Sample

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

AIDS/HIV PROBLEM
Not Provided
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
October 2013
September 2012   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
Contact: Gerald Ramirez gerald.ramirez@aidshealth.org
United States
 
NCT01507142
GAIA-AIDS-001
No
Gaia Medical Institute
Gaia Medical Institute
AIDS Healthcare Foundation
Principal Investigator: Wayne Chen, M.D. AIDS Healthcare Foundation
Principal Investigator: Sarka Southern, Ph.D. Gaia Medical Institute
Gaia Medical Institute
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP