lunes, 2 de diciembre de 2013

HIV Clinical Research Studies, NIAID, NIH

HIV Clinical Research Studies, NIAID, NIH

Leading Research to Understand, Treat, and Prevent Infectious, Immunologic, and Allergic Diseases

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Volunteer for NIAID HIV Studies
As we mark World AIDS Day 2013, NIAID investigators seek volunteers to help improve their understanding of HIV and how it causes disease, find new tools to prevent HIV infection, and develop new and more effective treatments.
Read about volunteer opportunities for NIAID HIV studies on the NIH campus in Bethesda, Maryland.

HIV Studies

The National Institutes of Health (NIH) houses the nation's most renowned biomedical research institutions. The following clinical research studies are being conducted by NIAID and the NIH Clinical Center in Bethesda, Maryland:

Characterization and Management of Patients With HIV-1 Infection Who Experience Virologic Failure Despite Combination Antiretroviral Therapy

(DOTCOM– Protocol #14-I-0009)

NIH is conducting a research study for people whose HIV infection is not currently under control, despite taking HIV medications. In general, the medicine used to treat HIV infection called antiretroviral therapy (ART) can decrease the amount of HIV virus in your blood (also called viral load or HIV RNA) to a very low level. This only happens if the ART drugs used still work to fight off the HIV virus from your body, and if you are taking the ART drugs every day, as instructed by your primary care doctor. When ART drugs no longer work against the HIV virus, the virus is said to become “resistant” to the drugs. We are interested in learning more about how to control HIV infection in people who can’t get a lower viral load despite receiving ART drugs.

A total of 100 subjects, 14 years of age or older, are expected to join the study. To be in the study, you must have a primary care doctor, and be willing to be hospitalized for the inpatient stays, have your blood samples stored, and undergo genetic testing. The study is currently open only to residents in the DC Metro area who can travel to the NIH in Bethesda, Maryland. Volunteers may be compensated.

Clinical Outcomes of Patients with HIV Acquired in Early Life

(COPE – Protocol #12-I-0157)

We would like to better understand how HIV infection and the medicines used to treat it affect the growth and development of youth and young adults who have been infected since early life. We want to find out if there are any problems with how HIV-infected children grow and develop as adults, particularly with regard to cardiovascular health. We are interested in studying your heart because HIV appears to be associated with an increased risk of heart disease. Volunteers will be compensated.​

A Cohort Observational Study Evaluating the Incidence and Immunopathogenesis of Immune Reconstitution Syndrome (IRIS) in HIV-1 Infected Patients with CD4 Count less than or equal to 100 Cells/microL who are Initiating Antiretroviral Therapy

(IRIS – Protocol #06-I-0086)

We will evaluate patients who are initiating antiretroviral therapy (ART) for HIV to see if they develop conditions that may be related to immune reconstitution syndrome (IRIS). The purpose is to study what factors may lead to IRIS, what the outcome is after IRIS, and how to better define IRIS. The study is open to HIV+ participants 18 years of age and older who have a primary care physician. Participants must have a T-cell count less than or equal to 100. Participants must live within a 120-mile radius from NIH in Bethesda, Maryland. Volunteers will be compensated.

Leukapheresis Procedures to Study HIV-Specific Immunity

(LTNP – Protocol #02-I-0086)

We will evaluate patients who have been able to control the progression of HIV for long periods without the use of antiretroviral therapy. Some immune system-related genes have been identified in people who are often labeled “long-term non-progressors” (LTNP). These HLA genes include B27, B35, B44, B57, B58, and/or A02. We will conduct genetic testing, blood collection, and tissue sampling in the hope of better understanding how some rare individuals can suppress HIV without medications. Volunteers will be compensated.

A Pilot Study of Hepatic Fibrosis in HIV/AIDS Patients with Chronically Elevated Transaminases on Antiretroviral Therapy

(TRANSAM – Protocol #06-CC-0153)

NIH is conducting a research study to evaluate HIV-positive patients, aged 18 and older, (without HBV or HCV co-infection) with chronically elevated hepatic transaminases while on HAART for evidence of fibrosis or other liver pathology by examining liver biopsy specimens. The study will include a screening visit, physical exam, laboratory tests, abdominal CT, and a liver biopsy procedure. A specialized ultrasound to look at liver stiffness may also be performed. There will be up to four visits prior to liver biopsy and four follow-up visits after biopsy. Financial compensation will be provided for visits completed.

Effect of Early Antiretroviral Therapy on Maintenance of Immune Cell Function

(RPHI – Protocol #02-I-0202)

This study is recruiting volunteers either at the Acute (early signs and symptoms of HIV infection and/or less than four months of known HIV exposure) and Chronic stage (greater than six months or determinate positive result) of infection and who have elected to begin HAART (provided by participant's Primary Care Provider). The study will require that patients be apheresed once before antiretroviral therapy and several times after suppression of plasma viremia (less than 50). Travel assistance will be provided (for non-local volunteers). Participants will be reimbursed for their time and inconvenience.

Leukapheresis Procedures to Obtain Plasma and Lymphocytes for Research on HCV-Infected Patients

(HCVRES – Protocol #04-I-0086)

Determining how the immune system of some patients is able to control hepatitis C virus (HCV) is felt to be a very important step for designing vaccines and therapies for HCV. Several studies have shown that coinfection with HIV adversely affects liver disease due to HCV. Our laboratory is recruiting patients to further understand the mechanism(s) involved in the interactions between HCV and HIV and how such interactions affect the progression of one another. In addition, for purposes of comparison, patients who are infected with HCV alone are also being recruited.

Strategic Timing of Anti-Retroviral Treatment

(START – Protocol #09-I-0108)

NIH is conducting a research study to evaluate the timing of when it is best to start taking HIV medications. Most guidelines agree that if the number of your CD4+ cells (cells in your blood which help fight infection) drops below 350 cells/mm3, or if you have symptoms of AIDS, you should start taking HIV medicines. In contrast, if your CD4+ cell count is above 350 cells/mm3, most current guidelines do not recommend starting HIV medicines right away. However, there is an increasing amount of evidence to suggest that in some cases this delay could be harmful. In order to answer this question definitively, NIH will be conducting a study comparing immediate versus delayed therapy in patients early in the course of their HIV infection (CD4+ cell counts ≥ 500 cells/mm3).

This study will be randomized; some participants will start HIV medications immediately, and some will be selected at random to start HIV medications following the current guidelines outlined above. Participation in the study will be approximately three years, and HIV medications will be provided, as indicated.

A Double Blind Randomized Placebo Controlled Study Examining the Effects of a Non-absorbable (Rifaximin) Antibiotic on the Chronic Immune Activation Observed in HIV-infected Subjects

(GUTCHEK – Protocol #13-I-0062)

You are being invited to participate in this research study because you are HIV-infected and are taking medications (antiretroviral therapy [ART]) for treating this infection. HIV treatment can control HIV, but therapy does not provide a cure. The reasons why therapy does not cure HIV infection are not well understood. HIV persists in blood cells for years, even while people are taking ART. In addition, HIV infection leads to an activated immune system, which can contribute to persistence. Immune activation improves, but does not fully resolve with ART. A better understanding of HIV and the immune activation HIV causes will help understand HIV persistence and identify new strategies to eliminate HIV infection.

In this study, we are investigating the source of immune activation in HIV infection. In general, chronic immune activation may be thought of as an exaggerated response to infection. It is not clear why HIV-infected patients have this exaggerated response. One theory why HIV infection causes immune activation has to do with the gastrointestinal tract. HIV infects immune cells the intestine (gut) soon after infection and causes damage to the intestinal immune barrier. The damage to the intestine lets bacterial products cross into the blood stream, leading to ongoing inflammation. Even when a person with HIV feels well, this chronic leakage of bacterial products may affect the immune system. In this study, we are planning to investigate whether taking Rifaximin, an antibiotic used to reduce bacteria in the intestine, will reduce leaking of bacterial products into the blood stream. Rifaximin is taken by mouth and is designed to stay inside the digestive system, so it's effects on bacteria are only within the intestines. Volunteers will be compensated.​

A Phase I Randomized, Double-Blind, Placebo-Controlled Study of a Multi-Antigen DNA Vaccine Prime Delivered by In Vivo Electroporation, rVSV Booster Vaccine in HIV- Infected Patients Who Began Antiretroviral Therapy During Acute/Early Infection

(THERAVAX – Protocol #13-I-0141)

NIH is conducting a research study to see how well people with HIV tolerate “therapeutic vaccination.” In most people infected with HIV, their immune system (the body’s normal ability to fight off disease) can’t control or cure the infection. Combination antiretroviral therapy (cART – a combination of anti-HIV drugs taken daily) can keep the amount of HIV virus very low for a long time. However, if treatment is stopped, the immune system isn’t able to control the infection, and HIV levels go up again. Also, cART doesn’t completely remove HIV from your body.

Therapeutic vaccination means giving a vaccine to TREAT an infection that someone already has (HIV in this case). Normally, we give vaccines to PREVENT a person from getting infections (for example, there are vaccines to prevent the flu and the measles).

We also want to see how levels of HIV, CD4 cells (the ‘good’ immune cells that are damaged by HIV), and other measures of HIV infection change after a person receives this vaccination. We plan to show this by stopping cART after some people have been given therapeutic vaccination and others have been given a placebo (a salt water-like solution that should have no effect), for comparison. Volunteers will be compensated.​

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