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HIV Infection clinical trials

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NCT ID: NCT01262846 Completed - HIV Infection Clinical Trials

Improving Immunogenicity of Influenza Vaccine in HIV Infected Individuals

Start date: November 2010
Phase: Phase 4
Study type: Interventional

The overall goal of this study is to compare the safety and immunogenicity of trivalent Fluzone® High-Dose vaccine vs the regular standard-dose (SD) in HIV infected individuals. Our hypothesis is that Fluzone® HD will be safe and more immunogenic than the currently used vaccine

NCT ID: NCT01261221 Completed - HIV Infection Clinical Trials

Pilot Study of Metabolic Syndromes and HIV Infections in Indian Tibetans

Start date: July 2010
Phase: N/A
Study type: Observational

Kaohsiung Medical University Chung-Ho Memorial Hospital will provide a long-term free medical service in Indian Tibetans since July 2010. The investigators plan to investigate metabolic syndromes and HIV infection in Indian Tibetan community. The investigators will survey the prevalence and risk factors by means of HIV quick test and questionnaires. Since there is lacking of prevalence survey for metabolic syndrome and HIV infection in Tibetan colony of India, the investigiators will carry out this survey under the support and assistance of Department of Health of Central Tibetan Government.

NCT ID: NCT01253850 Completed - HIV Infection Clinical Trials

Improving Antiretroviral Medication Adherence Among HIV-infected Youth: Phase I

Start date: August 2010
Phase: N/A
Study type: Observational

HIV is increasing among adolescents and young adults in the US. Antiretroviral medications, when taken correctly (≥90% of prescribed doses taken), can vastly improve life expectancy. However, adherence among HIV-infected young people is suboptimal, and few interventions are available to help adolescents adhere to treatment. The first phase of the study is an intervention development phase, which includes conducting interviews with 40 HIV-infected youth for input on the adaptation of the approach. The information obtained from the qualitative interviews is used to adapt the Life-Steps intervention (designed by our group for HIV-infected adults) to be responsive to the needs of HIV-infected adolescents, with acceptability of topics and content, and feasibility of intervention delivery to be tested in an open pilot trial.

NCT ID: NCT01252641 Completed - HIV Clinical Trials

Study of Autologous T-cells Genetically Modified at the CCR5 Gene by Zinc Finger Nucleases in HIV-Infected Subjects

Start date: November 2010
Phase: Phase 1/Phase 2
Study type: Interventional

This research study is being carried out to study a new way to possibly treat human immunodeficiency virus (HIV). The agent is called SB-728-T which are CD4+ T-cells obtained from an individual that are genetically modified at the CCR5 gene by Zinc Finger Nucleases. The CCR5 gene is required for certain types of HIV to enter into and infect T-cells. T cells are one of the white blood cells used by the body to fight HIV. The most important of these are called "CD4+ T-cells" Some people are born without the CCR5 gene on their T-Cells. These people remain healthy and are resistant to infection with HIV. Other people have a low number of CCR5 genes on their T-cells and their HIV disease is less severe and is slower to cause disease (AIDS). The purpose of this research study is to find out whether SB-728-T is safe to give to humans and find out how this affects HIV.

NCT ID: NCT01252537 Completed - Tuberculosis Clinical Trials

Immunosuppression in HIV-infected Patients With Tuberculosis in Ethiopia

Start date: September 2010
Phase: N/A
Study type: Observational

Background: Tuberculosis (TB) and HIV are leading causes of disease and death in Subsaharan Africa. Antiretroviral therapy (ART) dramatically improves prognosis in HIV infection, but TB is still a common complication in HIV-infected subjects. Management of TB-HIV co-infection is complex, both with regard to diagnosis and treatment. Since scaling-up of ART requires management of most patients in primary health care, it is critical to achieve better strategies for TB-HIV co-infection at peripheral levels of the health care system in endemic regions. This includes development of new methods to assess the severity of HIV disease and the need to start ART during TB treatment in this population. Aims: To compare a scoring system for clinical signs of immunosuppression with CD4 cell counts to assess HIV disease severity and indications for ART initiation, and to correlate immunosuppression status with treatment outcome. Workplan: CD4 cell levels and results of clinical scoring has been compared in 1100 patients with TB, using HIV-negative subjects with TB treatment for control. Inclusion was closed in February 2012, and follow-up of participants completed in August 2012. Plasma levels of immune activation and inflammatory markers will be correlated with the degree of immunosuppression. Significance: TB is the most significant clinical challenge to the successful scaling-up of ART in Africa. In order to improve management in primary health care it is necessary to find robust and reliable techniques for determining disease severity and identification of patients who need to start ART during TB treatment. This study may contribute to increased knowledge in this field and help to modify guidelines for management of TB-HIV co-infection in Ethiopia as well as in other resource-limited settings.

NCT ID: NCT01237444 Completed - HIV Infection Clinical Trials

Study of Lopinavir/ Ritonavir and Lamivudine Versus Standard Therapy in Naïve HIV-1 Infected Subjects.

GARDEL
Start date: December 2010
Phase: Phase 3
Study type: Interventional

The purpose of this study is designed to compare the safety, tolerability, antiviral activity and immunological effect of lopinavir/ritonavir plus lamivudine (3TC) versus standard therapy with 2 nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs) plus lopinavir/ritonavir in the treatment of naïve HIV-1 infected subjects.

NCT ID: NCT01228318 Completed - Osteoporosis Clinical Trials

Bone Loss and Immune Reconstitution in HIV/AIDS (BLIR-HIV)

BLIR-HIV
Start date: January 2011
Phase: Phase 2
Study type: Interventional

With the increasing age of people living with HIV/AIDS, age-induced osteoporosis is likely to be compounded by HIV/AIDS and HAART-associated bone loss. Mechanistically, osteoclasts the cells responsible for bone resorption form under the influence of the key osteoclastogenic cytokine receptor activator of nuclear factor kappa-Β ligand (RANKL). The osteoclastogenic and proresorptive activities of RANKL are moderated by its physiological decoy receptor osteoprotegerin (OPG). Imbalance in the ratio of RANKL to OPG alters osteoclastic bone resorption and lead to osteoporosis. Activated T- and B-cells are a major source of RANKL, while normal physiological B-cells are a major source of OPG. T-cells regulate the production of OPG by B-cells. Thus changes in the immune system induced by HIV/AIDS and/or by HAART could affect B-cell and T-cells RANKL and OPG production. Indeed, data from our group shows that in an animal model of HIV/AIDS, the HIV-1 Transgenic rat, the development of osteoporosis is recapitulated as observed in HIV-infected patients, and B-cell OPG and RANKL production are concurrently down regulated and upregulated respectively. Furthermore, preliminary data in HIV-infected subjects suggests dramatic acute upswing in bone resorption following HAART initiation that peaks at 12 weeks and then declines. Based on these findings, the investigators hypothesize HAART associated bone loss is driven by immune reconstitution. Because this effect of HAART is dramatic in magnitude but short in duration, the investigators propose to apply antiresorptive agent (zoledronic acid, reclast®) to specifically spare patients from this dramatic but acute bone damage.

NCT ID: NCT01227395 Completed - HIV Infection Clinical Trials

Drug Use Investigation On Zithromac (Azithromycin) In HIV Patients

Start date: July 2002
Phase: N/A
Study type: Observational

The investigation will be conducted for the purpose of determining the condition of occurrence of Adverse Events under the actual post-marketing use of Zithromac 600mg Tablet, verifying the therapeutic effects, detecting unknown Adverse Drug Reactions and drug interactions and determining the factors affecting safety and efficacy.

NCT ID: NCT01214876 Completed - Malaria Clinical Trials

Correlating Protection Against Malaria With Serum Profiles Against Plasmodium Falciparum Antigen Repertoires

Start date: August 2010
Phase: N/A
Study type: Observational

A longitudinal study on immune responses in relation to protection against clinical malaria episodes will be conducted in Apac District, Uganda. Three cohorts will be recruited: children 1 to 5 years of age (n=250), children 6 to 10 years of age (n=125) and adults 25 and above (n=125). After finger prick sampling (~300µL) and examination at enrolment, participants will be followed up for one year. Follow-up will include fortnightly active case detection and three-monthly cross-sectional surveys. Clinical malaria attacks and the associated clinical and parasitological parameters will be related to immunological profiles determined utilizing a protein microarray as a capture substratum to profile the humoral immune response against a vast number of parasite antigens. For individuals who experience a clinical malaria attack or who are diagnosed with high density parasitaemia (≥15,000 parasites/µL) during cross-sectional surveys, a 5mL blood sample is obtained to determine the diversity of parasite antigens in the population in relation to antigen recognition in the cohort.

NCT ID: NCT01208792 Completed - HIV Infection Clinical Trials

Auto-immunity and Pulmonary Arterial Hypertension

Auto-HTAP
Start date: June 15, 2010
Phase: N/A
Study type: Interventional

The investigators have recently evidenced the presence of antibodies to endothelial cells and fibroblasts in patients with idiopathic or SSc-associated PAH. The investigators also have identified several target antigens of anti-fibroblasts antibodies. The objective of this study is to further investigate for the presence of antibodies to endothelial cells and fibroblasts in patients and characterize the antigen specificity of autoantibodies in patients with different types of non idiopathic and non SSc-associated PAH, such as PAH associated with HIV infection, porto-pulmonary hypertension, congenital heart diseases, systemic lupus erythematosus, mixed connective tissue disease and Sjögren's syndrome