Active clinical trials for "HIV Infections"

This is a 48-week study to evaluate the safety, tolerability, pharmacokinetics, and antiviral activity of an investigational regimen including FDA approved HIV drugs in HIV-infected pediatric subjects, ages 4 weeks to < 2 years old.

This study will determine the safety and side effects of two experimental HIV vaccines given in a "prime-boost" schedule. It will also monitor participants for the social impact of being in an HIV vaccine study (e.g., problems with insurance, health care, friends, family, employment, housing, and so forth). The vaccines are VRC-HIVDNA016-00-VP (called the DNA vaccine) and VRC-HIVADV014-00-VP (called the rAd vaccine). The DNA vaccine codes for four HIV proteins. The rAd vaccine is made using an adenovirus (a common virus that causes upper respiratory infections, such as the common cold) that has been modified to contain DNA that codes for three HIV proteins. These vaccines cannot cause HIV or adenoviral infections. The study will also see if the vaccines cause an immune response; if the injection of the DNA vaccine given using a needle and syringe is similar in safety and immune response to giving them with a needleless injection device called a Biojector 2000; if people who already have antibodies to adenovirus still have an immune response to rAd vaccine; and if there are social harms that result from participating in an HIV vaccine study. Healthy volunteers between 18 and 50 years of age may be eligible for this 42-week study. Candidates are screened with a medical history, physical examination, blood and urine tests (including pregnancy test for women), and questions regarding sexual behavior and other practices. Participants receive three injections (shots) of the DNA vaccine and one injection of the rAd vaccine. All injections are given into a muscle in the upper arm (alternating right and left arms with each injection), using a needle and syringe or the needleless Biojector 2000. The first vaccination is given the day of enrollment into the study, and the DNA vaccinations are given about 4 weeks apart from each other, with a minimum of 21 days between injections. The rAd "booster"vaccination is given at Week 24. Participants fill out a diary card at home for 5 days after each vaccination, recording their temperature and any symptoms. They come to the clinic for follow-up 3 days each DNA vaccine injection, and call or return again 7 days after each injection. They call a study nurse 1 or 2 days after the rAd injection. There are 15 to 18 clinic visits during the course of the study. At each visit, participants are checked for health changes or problems. Blood and urine samples are collected at some visits. Participants are periodically tested for HIV and asked questions about their sexual behavior and drug use and are counseled throughout the study on HIV risk reduction. They are also asked about any social effects they may have experienced as a result of their participation in this study.

The purpose of this study is to evaluate the dose-response relationship of antiviral activity after 48 weeks treatment with 3 different dose regimens of TMC278.

Effective, suppressive treatment for HIV infected patients can be a major challenge because HIV progressively destroys their immune systems. CD8 cells isolated from a patient's blood and grown in large numbers in the laboratory may increase a patient's immune system response to HIV. The purpose of this study is to determine if CD8 cells will provide effective antiviral activity against HIV when transplanted back in large numbers into HIV infected patients. Study hypothesis: There are specific cells in the immune system that recognize and can kill HIV-infected cells.

This study will compare an anti-HIV drug combination of protease inhibitor plus a nonnucleoside reverse transcriptase inhibitor (NNRTI) to one that includes three nucleoside reverse transcriptase inhibitors (NRTIs) plus an NNRTI. NNRTIs, NRTIs, and protease inhibitors are all types of anti-HIV drugs that block the virus in some way. This study will try to find out if a treatment regimen containing a protease inhibitor plus an NNRTI has a different effect on the rise of CD4 cells compared to a treatment made up of three NRTIs plus an NNRTI. CD4 cells are cells of the immune system that fight infection. This study will also try to see if the combination of drugs used in this study is safe to use in HIV-positive patients.

The purpose of this study is to see if it is effective to give PEG-Intron (PEG-IFN) to HIV-infected patients who are not doing well with their current anti-HIV drug combination (HAART).

This study will evaluate whether interleukin-7 (IL-7) a drug similar to the natural IL-7 protein produced by the body, is safe to use in people infected with HIV. IL-7 is important in immune system function. In humans, it can extend the life of immune cells called T-cells and increase their function and maturation; in mice, it can speed up immune system recovery following chemotherapy of transplantation; and in monkeys, it can make T-cells increase in numbers. If this study shows that IL-7 is safe, other trials will determine if it can improve the numbers or function of T-cells in HIV-infected people. Patients 18 years of age and older with HIV infection who have been taking anti-HIV medications for at least 12 months, whose CD4 counts are at least 100 cells/microliter, and whose viral load is no more than 50,000 copies/milliliter may be eligible for this study. Candidates are screened with a physical examination, blood and urine tests, including a blood test for HLA type (a genetic test of markers of the immune system), chest x-ray, electrocardiogram, and ultrasound of the spleen. Participants undergo the following tests and procedures during 9 visits, as follows: Pre-entry visit Brief physical examination, including examination of lymph nodes and spleen. Medical history, including questions about current and past medications. Urine pregnancy test for women who are able to become pregnant. Blood draw for viral load, immune responses, and other routine safety tests. Entry visit Complete physical examination, including examination of lymph nodes and spleen. Routine urine test and urine pregnancy test for women who are able to become pregnant. Blood draw for viral load, immune responses, and other routine safety tests. IL-7 dosing. Participants are randomly assigned to receive one of five doses of IL-7 (3, 10, 30, 60 or 100 micrograms per kilogram of body weight) or placebo (a salt solution that does not contain IL-7). The dose may be given in one or more injections, with higher doses possibly requiring as many as seven or eight injections. The injections are given subcutaneously (under the skin), usually in the arm or leg. After the injection, patients are monitored closely for 12 hours for skin or allergic reactions. Blood is drawn before the injection and again at 0.5, 1, 1.5, 2, 2.5, 4, 8 and 12 hours after the injection to check blood levels of the study medication. Follow-up visits Patients come to the clinic 7 times during follow-up-every day for the first 4 days after the injection, then at 14 days, 4 weeks, and 8 weeks after the injection. At most study visits, patients have the following procedures: Brief physical examination, including examination of lymph nodes and spleen. Routine urine test and urine pregnancy test for women who are able to become pregnant. Blood draw for viral load, immune responses, and other routine safety tests. Blood test to measure the amount of study medication in the blood 1, 2, and 3 days after the injection Electrocardiogram 1 day after the injection

It is not known if anti-HIV treatment for recently infected patients improves long-term patient prognosis. The purpose of this study is to determine if a one year course of anti-HIV medications slows progression of HIV disease in adults recently infected with HIV. Study hypothesis: A one-year course of HAART administered during acute or early seroconversion may slow the progression of HIV infection.

The purpose of this study is to provide long-term clinical safety and efficacy data for tenofovir disoproxil fumarate and emtricitabine in HIV-infected patients experiencing various degrees of renal impairment.

This was a clinical trial in HIV infected patients with tuberculosis. The study assessed whether the addition of prednisolone, a type of steroid medication, to the standard treatment for tuberculosis improved immune and viral outcomes in the patients. The study demonstrated that prednisolone increased the CD4 cell count as was hoped, but the beneficial effect was short-lived and was gone within 4 months of stopping therapy. Therefore, the use of prednisolone for tuberculosis in HIV infected patients is not recommended at this time.