Active clinical trials for "Infections"

The purpose of this study is to determine the effect of an approved medication for adults for an investigational use in pediatric patients 3 months to 17 years for the treatment of complicated intra-abdominal infections or acute pelvic infections.

This 2 arm study will evaluate the efficacy, safety and tolerability of saquinavir/ritonavir or lopinavir/ritonavir in combination with emtricitabine/tenofovir in patients with human immunodeficiency virus type 1 (HIV-1) infection who have received no prior HIV treatment. Patients will be randomized to receive either saquinavir/ritonavir 1000/100mg oral (po) twice daily (bid) + emtricitabine/tenofovir 200/300mg po once daily (qd), or lopinavir/ritonavir 400/100mg po bid + emtricitabine/tenofovir 200/300mg po qd. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

This study will test the safety and immunogenicity of the gp120/NefTat/AS02A vaccine candidate in individuals with chronic HIV-1 infection successfully treated with HAART. The rationale for this study is based on previous scientific experiments, including data indicating that this vaccine can elicit strong HIV-1-specific T cell immune responses in humans and monkeys and lead to a retardation of HIV-1 disease progression in animal models of HIV-1 infection. The HIV vaccine to be administered during this study consists of three recombinant HIV clade B viral antigens: the envelope glycoprotein gp120 and two regulatory proteins, Nef and Tat.The antigens are formulated in a proprietary adjuvant, AS02A, comprised of two immunostimulants in an oil-in-water emulsion (gp120/NefTat/AS02A). The vaccine and the adjuvant are manufactured and provided for the study by GlaxoSmithKline Biologicals, Rixensart, Belgium. The drugs will be given by intramuscular (IM) injection at a standard dose of 20 mg together with 0.5 ml of the AS02A adjuvant. Twenty HIV-1 infected individuals will be randomly enrolled into three different study groups, receiving either the gp120/NefTat/AS02A vaccine (10 individuals), the AS02A adjuvant alone (5 individuals) or a placebo (5 individuals). After obtaining informed consent, subjects will have a history and physical exam performed and have laboratory tests to confirm they meet all inclusion and exclusion entry criteria. Women of childbearing potential will have a pregnancy test prior to each injection of the investigational product. Injections with vaccine, adjuvant alone, or placebo will then be performed at weeks 0, 4, and 12. Study participants will undergo close monitoring after each vaccination. Blood samples will be obtained for immunological assays at study baseline (2 times) and weeks 2, 4, 6, 12, 14, 24, and 48. All patients will maintain their antiretroviral treatment regimen during the entire study period.

Successful therapy of both tuberculosis and HIV disease share similar problems: pill burden, drug interaction, adherence challenge and toxicity. This study will test the efficacy and safety of a once daily antiretroviral regimen in HIV-tuberculosis coinfected patients.

This is a randomized multicentre trial of emtricitabine (FTC) versus tenofovir (TDF)/FTC in antiretroviral naive subjects with HIV/HBV co-infection over 48 weeks (Clinical Trial A). Plus, a 12 week viral kinetic substudy comparing a subgroup of patients on Clinical Trial A is being conducted. (Substudy A1)

The purpose of this study is to compare the safety and effectiveness of levofloxacin (an antibiotic) with ticarcillin/clavulanate alone or followed by amoxicillin/clavulanate in the treatment of complicated skin infections.

The purpose of this study is to evaluate whether the HIV vaccine VRC-HIVDNA009-00-VP will be safe in individuals who started antiretroviral therapy during acute HIV-1 infection. The study will also test whether the vaccine can increase the immune system function in these participants.

The purpose of the study is to see if giving vitamin and mineral supplements helps to protect infants and children from diarrhea, which vitamins and minerals help to improve a child's weight and growth, and if the same results occur in infants and children with HIV. HIV is the virus that causes AIDS. Study participants will include 516 infants aged 4-6 months. Participants will include: (1) HIV-infected children, (2) HIV-uninfected children with HIV-infected mothers, and (3) HIV-uninfected children with HIV-uninfected mothers. Subjects will have an equal chance of receiving one of three different vitamin and/or mineral supplements during the study. Study procedures will include up to 7 blood samples and stool samples every 3 months and body composition every 6 months. Participants will be involved in the study for up to 18 months.

OBJECTIVES: I. Evaluate the safety, tolerance, and potential efficacy of 3 doses of human anti-cytomegalovirus (CMV) monoclonal antibody SDZ MSL-109 (MOAB MSL-109) in the treatment of newborns with congenital CMV infection and no central nervous system disease. II. Determine the relationship between plasma concentrations of MOAB MSL-109 and therapeutic outcome. III. Determine whether MOAB MSL-109 influences the antibody response and clearance of virus from the urine.

This study will evaluate the safety and effectiveness of adefovir plus lamivudine for chronic hepatitis B infection in people with and without HIV infection. Lamuvidine, an FDA-approved treatment for hepatitis B infection, also works against HIV. In some patients, the hepatitis B virus (HBV) continues to reproduce despite lamivudine treatment. Adefovir is an experimental drug that inhibits HBV replication and may work against some strains of the virus that have become resistant to lamivudine. Patients 21 years of age or older with active hepatitis B infection despite treatment with lamivudine for at least 1 year may be eligible for this 48-week study. Patients both with or without HIV infection may participate. Candidates will be screened with a medical history, blood and urine tests, liver ultrasound exam, electrocardiogram (EKG) and chest X-ray. Participants will have a physical examination, review of their medical history, blood tests, and a 24-hour urine collection. They will be admitted to the hospital for a liver biopsy to determine if they can receive the study drug. For this procedure, the patient is given a sedative for relaxation. The skin over the biopsy is numbed with an anesthetic and the biopsy needle is passed rapidly into and out of the liver to collect a tissue specimen. Patients are monitored in the hospital overnight for possible complications. After discharge, they return home and begin taking the study medications. Patients will be randomized to two treatment groups. One group will take 10 milligrams/day of adefovir by mouth, and the other will take a placebo-a lookalike pill with no active ingredient. Both groups will also take 150 mg lamivudine by mouth and L-carnitine pills or liquid. Patients with HIV infection will continue to take antiretroviral therapy as well. Patients will be followed in the clinic at study weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40 and 44 for blood and urine tests to determine the safety of the drug and to evaluate the response to treatment. On week 48, a repeat 24-hour urine test and repeat liver biopsy will be done. At the end of the 48 weeks, patients may continue to receive adefovir for another 48 weeks and possibly longer. All those who participate in this extension phase will receive active adefovir, regardless of whether they had previously taken adefovir or placebo. All patients will have the option to enroll in a separate study to examine the levels of HBV (and levels of HIV in HIV-infected patients) in the blood immediately after starting treatment and to determine if these initial levels can predict later outcome. This involves seven additional visits, for which participants will be compensated. At these visits, blood will be drawn on study days 0 (before starting drug treatment), 1, 3, 5, 7, 10 and 21 for HIV and HBV viral loads and specialized immunology tests.