Status:
COMPLETED
Rapid Oral Test for Therapeutic Response in HIV/AIDS Patients
Lead Sponsor:
Gaia Medical Institute
Collaborating Sponsors:
AIDS Healthcare Foundation
Conditions:
AIDS/HIV PROBLEM
Eligibility:
All Genders
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 1 2013
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT01507142
Start Date
October 1 2011
End Date
October 1 2013
Last Update
February 15 2018
Active Locations (1)
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1
AIDS Healthcare Foundation
Los Angeles, California, United States, 90211