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HIV Infections clinical trials

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NCT ID: NCT00458302 Completed - HIV Infections Clinical Trials

Treatment Simplification by Darunavir/Ritonavir 800/100 mg Once a Day Versus a Triple Combination Therapy With Darunavir/Ritonavir

MONET
Start date: June 2007
Phase: Phase 3
Study type: Interventional

The purpose of the study is to compare the efficacy, safety and tolerability of darunavir/ritonavir 800/100 mg once a day (O.D.) as a monotherapy versus a triple combination therapy containing 2 nucleosides and darunavir/ritonavir in 250 HIV-1 infected patients who have been on Highly Active Antiretroviral Therapy (HAART) and have plasma viral load below 50 copies/ml for at least 24 weeks.

NCT ID: NCT00457665 Completed - HIV Infections Clinical Trials

Mechanisms of Lipodystrophy in HIV-Infected Pateints

Start date: February 2002
Phase: Phase 4
Study type: Interventional

The metabolic and molecular basis of lipodystrophy syndrome in HIV-infected patients is not known. Whether besides protease inhibitors, other antiretroviral drugs, HIV infection and reduction in viral load contribute to the development of lipodystrophy syndrome is not clear. The project therefore has the following aims: 1) to characterize metabolic abnormalities and changes in body fat distribution, 2) to develop objective criteria for defining the syndrome and to ascertain prognostic indicators and 3) to elucidate the molecular basis of the lipodystrophy syndrome in HIV-infected patients.

NCT ID: NCT00456664 Completed - HIV Infections Clinical Trials

CMV Disease and IRIS in HIV-1 Infected Persons

Start date: November 2006
Phase: N/A
Study type: Observational

Various diagnostic methods are available for CMV infection. But none of them could be a standard and highly valuable. Our first goal is to setup a series of molecular diagnostic tools for HIV-1 infected person. By using these tools, physicians can easily select cases with CMV disease or immune restoration inflammatory syndrome (IRIS) to enroll this study. Furthermore, we will seek for a predict marker for CMV reactivation, CMV disease and IRIS. Finally, our research will focus on the mechanism of the IE gene alternative splicing between lytic and latent stage.

NCT ID: NCT00455793 Completed - HIV Infections Clinical Trials

Subclinical Atherosclerosis in HIV-infected Patients

Start date: June 2006
Phase: N/A
Study type: Observational

We will obtain data using multi-slice CT technology to detect subclinical coronary disease in the HIV population. Determination of subclinical cardiovascular disease using noninvasive technology and elucidation of the associated risk factors will help to guide targeted therapy to prevent cardiovascular events in this patient population. We will investigate the prevalence of coronary plaque lesions and coronary artery calcifications in men and women with HIV disease as determined by 64-row multidetector computed tomography (MDCT) and MDCT coronary angiography in comparison to age-matched control subjects without HIV infection. We hypothesize that evidence of coronary artery calcification and coronary plaque lesions as seen by MDCT will be present in individuals with HIV more than non-HIV control subjects of the same age. We also hypothesize the degree of atherosclerosis will be increased in HIV patients compared to control subjects. We will evaluate the metabolic and inflammatory factors associated with coronary artery disease in HIV-infected individuals. We hypothesize that traditional cardiac risk factors as well as metabolic and inflammatory changes associated with HIV and its treatment such as dyslipidemia, increased secretion of inflammatory markers, decreased adiponectin, increased insulin resistance and increased visceral fat may be associated with coronary artery disease in HIV-infected individuals.

NCT ID: NCT00455585 Completed - HIV Infections Clinical Trials

Comparison of Plasma Drug Levels of Triomune 40 With Those of the Originator Products

Start date: January 2007
Phase: Phase 4
Study type: Interventional

This study aims to compare the steady state pharmacokinetics of stavudine, lamivudine, and nevirapine in HIV positive Ugandan patients taking Triomune 40 with the pharmacokinetics of the originator products known as Viramune, Epivir and Zerit 40.

NCT ID: NCT00454337 Completed - HIV Infections Clinical Trials

Efficacy and Tolerance of the Switch From Enfuvirtine to Raltegravir in Antiretroviral Therapy Regimen in HIV Patients With Undetectable Viral Load

EASIER
Start date: May 2007
Phase: Phase 3
Study type: Interventional

Switching from enfuvirtide to raltegravir in the treatment of HIV-infected patients who sustain viral suppression with a combination therapy including enfuvirtide (or : with an enfuvirtide-based combination therapy)

NCT ID: NCT00454181 Completed - HIV Infections Clinical Trials

Treatment of Oral Warts in HIV+ Patients

Start date: February 2007
Phase: Phase 2
Study type: Interventional

This is a study to test lozenges of interferon-alpha that are dissolved in the mouth as a treatment of oral warts in HIV-positive adults. The hypothesis of this study is that interferon-alpha will be safe and that a higher percentage of subjects given interferon-alpha will experience a complete or nearly complete remission of their oral warts compared to subjects given placebo.

NCT ID: NCT00453440 Completed - Clinical trials for Infection, Human Immunodeficiency Virus

Prospective Epidemiological Study Of The Prevalence Of HLA-B*5701

Start date: March 20, 2007
Phase: N/A
Study type: Observational

This is a study to determine the prevalence of a genetic marker, HLA-B5701, in the UK population. HLA-B*5701 has been strongly associated with the risk of an allergic reaction to a HIV medicine, Abacavir. The allergic reaction is known as a hypersensitivity reaction. The study is a prospective study inviting HIV-1 positive patients over the age of 18 years to participate. Each participant will complete one study visit. They will be asked for details of their background including their age, sex, ethnicity, country of origin and parental country of origin. They will be asked to give two samples to test for the presence of the genetic marker HLA-B*5701. The two samples are: - A cheek swab - A blood sample In selected centres patients may be asked to provide up to two additional blood samples. These samples will be used to help develop and validate new methods of determining HLA-B*5701 testing.

NCT ID: NCT00451984 Recruiting - HIV Infections Clinical Trials

Hepatitis Vaccination in HIV Infection: Role of Adjuvant Interleukin-2

HEPVACHIV
Start date: March 2007
Phase: Phase 3
Study type: Interventional

The response to vaccination for hepatitis is reduced in patients with HIV infection. The hypothesis of the study is that adjuvant interleukin-2 administered subcutaneously at the time of vaccination improves the response rate.

NCT ID: NCT00450580 Completed - HIV-1 Infection Clinical Trials

HIV-1 Infection Study of Once a Day Versus Twice a Day Protease Inhibitor in Antiretroviral Treatment Naive Adults

Start date: March 2007
Phase: Phase 3
Study type: Interventional

This is a Phase IIIB, 48 Week, multicentre, randomized, open-label, parallel group study comparing the safety and efficacy of fosamprenavir plus ritonavir 1400mg/100mg once-daily to fosamprenavir plus ritonavir 700mg/100mg twice-daily, both administered with abacavir/lamivudine 600mg/300mg once-daily in antiretroviral-naive HIV-1 infected adults. This study utilizes a group-sequential design with two stages: 1) an interim 24 week cohort analysis of approximately 200 subjects and 2) if study continuation criteria are met at this interim analysis, further enrolment of an additional 528 subjects, followed over a minimum of 48 weeks. The objectives of the study are to demonstrate 1) non-inferior antiviral activity of fosamprenavir/ritonavir 1400mg/100mg QD compared to fosamprenavir/ritonavir 700mg/100mg BID and 2) a superior fasting non-HDL lipid profile in subjects receiving fosamprenavir/ritonavir 1400mg/100mg QD.