Status:
COMPLETED
Study of the Effect of SNPs in p53 and p53 Response Elements on the Inflammatory Response to DNA Damage
Lead Sponsor:
National Institute of Environmental Health Sciences (NIEHS)
Conditions:
HIV-1 Seropositive
Inflammation
Eligibility:
All Genders
18-100 years
Brief Summary
Background: \- Research has shown that certain proteins in cells may be linked to higher risks of developing inflammations, tumors, and other medical problems. By examining how the blood cells of hea...
Detailed Description
This research study will investigate the role of SNPs in p53 and p53 response elements on the inflammatory response to DNA damage. A total of 200 participants aged 18 years and older carrying one of t...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Male or female 18 years of age or older
- Participants must be able to understand and provide written informed consent to participate in the study
- Participants must be able to travel to the CRU
- Nonpregnant
- Healthy participants as defined by the International Red Cross guidelines (Healthy means that an individual feels well and can perform normal activities. If the individual has a chronic condition such as diabetes or high blood pressure, healthy also means that they are being treated and the condition is under control).
- Participants with health outcomes identified by genotype-phenotype association studies.
- HIV-1 seropositive under medicament treatment (for HIV P53 and TLR8 groups only) (checked every 6 months at visit)
- EXCLUSION CRITERIA:
- Use of immunosuppressants or other immune-modifying drugs \[e.g., Rituxan, Humira, Enbrel, Cyclosporin (Neoral, Sandimmune, and SangCya), Azathioprine (Imuran)\], Monoclonal antibodies \[e.g., infliximab (Remicade)\] (for healthy controls only)
- Chronic use of systemic, inhaled steroids
- Current or use of prescription strength topical corticosteroids within the last 7days
- History of cancer, including skin cancer (for healthy controls only)
- History of chemotherapy or radiation treatment (for healthy controls only)
- Confirmed or suspected immunosuppressive or immunodeficient condition (for healthy controls only)
- Hepatitis B/C-positive status (checked every 6 months at visit)
- Body weight \< 50 kg (\<110 lbs)
- If blood donation exceeds 200ml:
- -Hematocrit \<34% for women or \<36% for men, or \>56% for either gender
- Temperature \> 37.6 C; blood pressure \< 90/50 mm Hg or blood pressure \>160/100 mm Hg; pulse rate \< 50 or \> 100 beats/minute
- Blood or plasma donation that will cause the participant to exceed 550ml of blood in the last 8 weeks
- HIV1 donors with opportunistic infections:
- Candidiasis of bronchi, trachea, esophagus, or lungs
- Invasive cervical cancer
- Coccidioidomycosis
- Cryptococcosis
- Cryptosporidiosis, chronic intestinal (greater than 1 month's duration)
- Cytomegalovirus disease (particularly CMV retinitis)
- Encephalopathy, HIV-related
- Herpes simplex: chronic ulcer(s) (greater than 1 month's duration); or bronchitis, pneumonitis, or esophagitis
- Histoplasmosis
- Isosporiasis, chronic intestinal (greater than 1 month's duration)
- Kaposi's sarcoma
- Lymphoma, multiple forms
- Mycobacterium avium complex
- Tuberculosis
- Pneumocystis carinii pneumonia
- Pneumonia, recurrent
- Progressive multifocal leukoencephalopathy
- Salmonella septicemia, recurrent
- Toxoplasmosis of brain
- Wasting syndrome due to HIV
- HIV and hepatitis results will be confidentially obtained. Testing will be contracted to an external certified laboratory. Results will be available only to the study team, with the few caveats that follow:
- All positive HIV, hepatitis B, and hepatitis C results that are unexpected (i.e. participant is not currently enrolled in the EPR as an HIV-1 seropositive under medicament treatment) will be promptly communicated to the donor by the study doctor/PI or the CRU Director. The participant will be referred to their physician and/or to the N.C. Department of Health for confirmatory testing and counseling. As explained in detail in the attached Supplement describing N.C. State Department of Health code will be followed. The state code mandates reporting of positive results along with the participant s name and identifying information to the N.C. Department of Public Health. Upon contracting with the testing laboratory, clarification will be obtained and documented as to whether the contracted laboratory or the study MD will be responsible for reporting positive results to the state to avoid duplication of reporting. Upon receipt of the test results, the N.C. Department of Health will contact the participant to inform them of the positive result, how to find care, how to avoid infecting others, how the newly diagnosed HIV and/or hepatitis infection is reported, and the importance of informing their partners at possible risk because of their HIV and/or hepatitis infection. If the HIV, hepatitis B, and hepatitis C results are negative, the participant will be not be notified. However, the participant may contact the research study nurse for their results.
- HIV and hepatitis B/C test results, non-reactive and reactive, will be documented confidentially by the PI or study coordinator in the subject s file, and kept in a locked file cabinet in the CRU Medical Records Room. In order to document the reporting procedure and the time associated with the reporting process, a document has been created and placed in the study specific manual (Hepatitis B/C and HIV Notification Process for Reactive Results Form).
- Healthy control participants carrying SNPs TLR8 and FLT1 who are currently taking hormonal contraception (e.g. oral contraceptives, IUDs with hormones, contraceptive patches) or hormone replacement therapy will be excluded from the study unless the participant has been off of the hormone treatment for 1 month or longer.
Exclusion
Key Trial Info
Start Date :
May 21 2012
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
178 Patients enrolled
Trial Details
Trial ID
NCT01143519
Start Date
May 21 2012
Last Update
January 5 2026
Active Locations (1)
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1
NIEHS Clinical Research Unit (CRU)
Research Triangle Park, North Carolina, United States