Active clinical trials for "Acquired Immunodeficiency Syndrome"

The purpose of this study is to determine whether patients who have asymptomatic HIV infection can discontinue antiretroviral therapy (ART) without adverse clinical, virologic, or immunologic consequences. This study will also assess the virologic, immunologic, and clinical outcomes in any patients who restart ART.

This study will evaluate a new program designed to increase condom use in both women and men.

The SASA! Study is a cluster randomized trial of a community mobilization intervention for the prevention of HIV and gender based violence. The study is being conducted in Kampala, Uganda.

In many areas of the world most severely affected by the HIV/AIDS pandemic, insect and water-borne diseases such as malaria and diarrheal disease are common causes of illness and death. In addition, diarrhea and malaria are more common and more severe among adults and children infected with HIV. These infections may modulate the immune system, affect the replication of the HIV virus and could result in more rapid HIV disease progression in co-infected individuals. Access to practical, inexpensive and easy to use interventions to prevent these diseases may be effective in delaying HIV progression. Current Kenya government and World Health Organization guidelines recommend the use of cotrimoxazole (trimethoprim-sulfamethoxazole [TMP/SMX]) to prevent co-infections, including malaria. Despite the provision of TMP/SMX to HIV-infected adults, infections with malaria and pathogens causing diarrhea remain common causes of morbidity and mortality in many resource-limited settings. In addition, TMP/SMX may not prevent all infections with malaria or other pathogens due to alternative mechanisms of action, antimicrobial resistance and non-compliance due to adverse events or other reasons. We propose a study to evaluate the impact of providing insecticide treated bednets and a simple water filtration device on markers of HIV disease progression among a cohort of ART naïve, HIV infected adults prescribed TMP/SMX in Kenya. In addition, we propose to evaluate the effect of these interventions on malaria and diarrheal disease incidence and on compliance with TMP/SMX.

This survey is conducted for preparing application materials for re-examination under the Pharmaceutical Affairs Laws and its Enforcement Regulation, its aim is to reconfirm the clinical usefulness of Isentress through collecting the safety and efficacy information in usual practice according to the Re-examination Regulation for New Drugs. Post-marketing surveys are not considered applicable clinical trials and thus the results of this survey will not be posted at its conclusion. The results will be submitted to public health officials as required by applicable national and international laws.

This open-label study will enable HIV-infected adults with limited treatment options to receive fosamprenavir until commercial supplies are available in Switzerland.

Study Hypothesis: Do certain risk behaviours impact/predict levels of HIV antiretroviral adherence? Objectives: To assess risk behavior in HIV-positive individuals receiving highly active antiretroviral therapy.(HAART) To assess levels of adherence in the same subjects at the same time point To determine if there is a correlation between HAART adherence and risk behaviour

The proposed study has two specific aims 1) to gather data about treatment adherence levels among adolescents (11-21 years) with HIV and 2) to obtain information about the adolescents and mothers' health beliefs and examine their relationship to the adolescents' adherence levels. This pilot study is designed to gather preliminary data about the feasibility of using several new measures with this population. To achieve these aims, a convenience sample of approximately 45 adolescents with HIV will re recruited. The adolescents and their mothers will complete a brief questionnaire about their health beliefs. A 24-hour recall interview format will be used to assess the adolescents' treatment adherence to prescribed oral medication. The adolescent will complete recall interviews on three random days over a two week period. Data analysis will be primarily descriptive, but will be used to generate more specific hypotheses for future research studies. The long-term goal of this research is to better identify adolescents with HIV at risk for non-adherence and design empirically derived interventions to improve their adherence levels. The health beliefs measure may also be useful in identifying irrational beliefs about the illness or treatment that can then be targeted for cognitive restructing in psychological interventions.

This study will evaluate the safety of giving lymphocytes (white blood cells) containing a new gene to HIV-infected individuals and will determine how long the cells survive in the bloodstream. Although the genetically altered cells will not directly benefit participants, knowledge about the safety, side effects and survival of these gene-marked cells in HIV-infected patients may lead to new treatment strategies. Identical twin pairs 18 years of age and older-one infected with HIV, the other non-infected-may be eligible for this study. Candidates will be screened with a medical history, physical examination and blood tests. All participants will have a tetanus booster shot. Non-infected twins will undergo a procedure called apheresis to collect white blood cells. For this procedure, whole blood is collected through a needle in an arm vein, similar to donating blood. The blood is separated it into its components by centrifugation (spinning), the white cells are removed, and the rest of the blood is returned to the body, either through the same needle or through another needle in the other arm. The harvested white cells will be grown in culture for approximately 10 days to 2 weeks to increase their numbers up to 1000-fold. A gene called NeoR, which is derived from bacteria, will be inserted into the cells, and these gene-marked cells will be infused into the HIV-infected twin. HIV-infected twins will be admitted to the NIH Clinical Center for the first cell infusion. The gene-marked cells will be infused over a 60-minute period through a plastic tube (catheter) placed in an arm vein, or, if a suitable arm vein cannot be found, through a special catheter placed into a large vein in the neck or chest. Vital signs (temperature, pulse, blood pressure and breathing rate), blood oxygen concentration, and urine output will be monitored regularly for 24 hours. Blood samples will be collected before and after the infusion to monitor for gene-marked cells. Patients will be discharged the next day. They will return to NIH daily the first week (from Monday through Thursday) to monitor for CD4 cell counts, plasma viral burden, p24 antigen levels, HIV levels and the presence of the NeoR gene, and then weekly for the next 5 weeks for these tests and others to monitor blood and urine chemistry, blood counts and immune function markers. If the NeoR gene cannot be detected after the first cell infusion, the entire procedure (donor apheresis, gene marking and infusion of cells) will be repeated twice-about once every 6 weeks. If the first infusion was uncomplicated, the second and third infusions may be done on an outpatient basis, with monitoring for 6 hours rather than 24. Six weeks after the third infusion, tests will be scheduled monthly for 6 months and then yearly for long-term follow-up. In addition to the above procedures, patients with a baseline CD4 lymphocyte count less than 100 cells per cubic millimeter of blood will be asked to undergo apheresis periodically to obtain the most accurate results for determining how long the NeoR gene persists in the blood. The procedure will be done weekly for the first 6 weeks after each infusion of cells, then at week 8, and then every 4 weeks until the gene can no longer be detected in the lymphocytes. The schedule may change, but will not require more frequent apheresis.

To correlate HIV-1 viral load in vaginocervical secretions (VCS), as measured by culture and nucleic acid detection, with that found in peripheral blood and HIV clinical status. To determine whether systemic and local HIV specific antibody influences the quality and type of virus isolated from VCS. To ascertain whether the presence of specific infectious agents (e.g., HPV, HSV, CMV, etc.) influences the amount and type of virus isolated from VCS. Predictors for the development of the acquired immunodeficiency syndrome (AIDS) in HIV infected individuals have been studied primarily among adult males and in selected small populations. Although many of these predictors may be relevant to women, HIV infection does manifest itself differently between the sexes. Therefore, it is important to study the spectrum of HIV disease in women and to identify unique and common markers, cofactors, and predictors of disease progression.