Status:
TERMINATED
Evaluation of a Blood Test to Measure Immune Function in HIV Positive People Compared With HIV Negative People
Lead Sponsor:
QIAGEN Gaithersburg, Inc
Conditions:
HIV Positive
Eligibility:
All Genders
18-65 years
Brief Summary
The health of the immune system in HIV infected people is currently determined from a blood test measuring the number of cluster of differentiation 4 (CD4) T lymphocytes. These cells play a critical r...
Detailed Description
Routine virologic and immunologic tests to monitor HIV-1 in infected individuals on highly active antiretroviral therapy (HAART) include CD4 T-cell enumeration, HIV-1 plasma viral load, and HIV-1 geno...
Eligibility Criteria
Inclusion
- Anti-retroviral drug naïve, (never on treatment, or \>60 days off treatment), n=30
- All plasma viral load results within the last 24 months; most recent plasma viral load result of any value used for enrollment.
- All CD4 results within the last 24 months; most recent CD4 result used for enrollment: CD4\>500/microliter (uL) (n=15) or CD4\<500/uL (n=15).
- Successful HAART \> 24 months with two undetectable plasma viral load within the last 12 months, n=30
- All plasma viral load results within the last 24 months; two most recent plasma viral load results within last 12 months must be undetectable and used for enrollment.
- All CD4 results within the last 24 months; most recent CD4 result used for enrollment: CD4\>500/uL (n=15) or CD4\<500/uL (n=15).
- On HAART \> 24 months with latest plasma viral load \>200, n=30
- All plasma viral load results within the last 24 months; most recent plasma viral load result \>200 and used for enrollment.
- All CD4 results within the last 24 months; most recent CD4 result used for enrollment: CD4\>500/uL (n=15) or CD4\<500/uL (n=15).
- HIV Uninfected Controls (n=30):
- Documentation of HIV seronegative status at time of enrollment
Exclusion
- Key Exclusion Criteria for all HIV Infected only:
- Primary infection: \< 6 months after documented HIV-1 antibody positive test
- Key Exclusion Criteria for drug naïve HIV Infected only
- Ended HIV medications less than 2 months before the study
- Key Exclusion Criteria for HIV uninfected only:
- On HIV-1 pre-or post exposure prophylaxis \<21 days before enrolment
- Key Exclusion Criteria for all subjects:
- \<18 or \>65 years of age
- Pregnant or lactating subjects
- Documented hepatitis B virus (HBV) and/or hepatitis C virus (HCV) Infection
- Proven or suspected acute hepatitis
- Transient clinical manifestation (i.e., cold, flu, measles, etc). Eligible when resolved
- Evidence of a gastrointestinal malabsorption syndrome, chronic inflammatory disease (i.e. Crohn's Disease) or chronic nausea or vomiting
- Prior history of significant renal or bone disease
- Malignancy other than cutaneous Kaposi's sarcoma or basal cell carcinoma
- \< 30 days after any vaccination. Eligible 30 days post vaccination.
- Current alcohol or substance abuse
- Active, serious infections (other than HIV infection) requiring parenteral antimicrobial therapy within 30 days prior to enrollment.
- Any other clinical condition in the opinion of the PI, would make the subject unsuitable for the study i.e. active cytomegalovirus (CMV) and Epstein-Barr virus (EBV) infection, diabetes, Rheumatoid Arthritis, etc.
- Previous therapy with agents with systemic myelosuppressive, pancreotoxic, hepatotoxic or cytotoxic potential within 3 months of study start or the expected need for such therapy at the time of enrollment
- On therapy that suppresses bone marrow, toxic to liver and pancreas
- On ongoing therapy that is toxic to kidneys including aminoglycoside antibiotics, amphotericin B, cidofovir, cisplatin, foscarnet, IV pentamidine, other agents with significant nephrotoxic potential
- Creatinine clearance \< 60 mL/min
- On anti-cancer therapy
- On ongoing therapy with immunosuppressive agents
- On ongoing chemotherapeutic agents
- On ongoing systemic corticosteroids
- On ongoing systemic interleukin 2 or other cytokine therapy
- Anticonvulsants (eg. Carbamazepine, Phenytoin, Valproate)
- Monoclonal antibody therapy (eg. Muromonab OKT3)
- Any other prior therapy that, in the opinion of the PI, would make the subject unsuitable for the study.
- How long will it take? One visit for about 1 hour with Dr. Gatpolintan and his Clinical Study Coordinator to answer questions, then about 10 minutes for a blood draw (nine blocks from Dr. Gatpolintan' office).
Key Trial Info
Start Date :
July 1 2013
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 1 2014
Estimated Enrollment :
57 Patients enrolled
Trial Details
Trial ID
NCT01904201
Start Date
July 1 2013
End Date
June 1 2014
Last Update
July 9 2014
Active Locations (1)
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1
Sutter Street Internal Medicine
San Francisco, California, United States, 94109