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
  Purpose

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
AIDS/HIV PROBLEM

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Rapid Oral Test for Therapeutic Response in HIV/AIDS Patients

Resource links provided by NLM:


Further study details as provided by Gaia Medical Institute:

Biospecimen Retention:   Samples Without DNA

Saliva


Estimated Enrollment: 100
Study Start Date: October 2011
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01507142

Contacts
Contact: Gerald Ramirez gerald.ramirez@aidshealth.org

Locations
United States, California
AIDS Healthcare Foundation Recruiting
Los Angeles, California, United States, 90211
Contact: Gerald Ramirez    323-662-0492 ext 15406    gerald.ramirez@aidshealth.org   
Principal Investigator: Wayne Chen, MD         
Sponsors and Collaborators
Gaia Medical Institute
AIDS Healthcare Foundation
Investigators
Principal Investigator: Wayne Chen, M.D. AIDS Healthcare Foundation
Principal Investigator: Sarka Southern, Ph.D. Gaia Medical Institute
  More Information

No publications provided

Responsible Party: Gaia Medical Institute
ClinicalTrials.gov Identifier: NCT01507142     History of Changes
Other Study ID Numbers: GAIA-AIDS-001
Study First Received: January 6, 2012
Last Updated: July 16, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Gaia Medical Institute:
saliva
diagnostics
HIV
AIDS

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immunologic Deficiency Syndromes
Immune System Diseases

ClinicalTrials.gov processed this record on August 01, 2014