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HIV Infections clinical trials

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NCT ID: NCT01737359 Terminated - Clinical trials for Human Immunodeficiency Virus Infection

A Safety and Efficacy Study of Amdoxovir in HIV-1 Treatment-experienced Subjects.

Start date: December 2012
Phase: Phase 2
Study type: Interventional

This is a double-blind Phase 2a study to test the safety and efficacy of an investigational HIV drug, amdoxovir (300 mg or 500 mg twice daily) compared with tenofovir DF 300 mg once daily in HIV-1 infected antiretroviral therapy-experienced subjects who are currently failing antiretroviral therapy. There are three treatment groups (N=45). Subjects will be randomized to receive either amdoxovir 300 mg twice daily (n=15) or amdoxovir 500 mg twice daily (n=15) or tenofovir DF 300 mg once daily (n=15); each in combination with zidovudine 300 mg twice daily. The study will assess initially amdoxovir (300 mg or 500 mg twice daily) or tenofovir DF 300 mg once daily, both in combination zidovudine 300 mg twice daily plus failing third drug, but then with lopinavir/ritonavir (400 mg/100 mg twice daily) after Week 2. Subjects who received amdoxovir (300 mg or 500 mg twice daily) and benefited from the drug may choose to enroll in the 36-week open-label study.

NCT ID: NCT01731691 Terminated - HIV Disease Clinical Trials

Safety and Efficacy of (α1Proteinase Inhibitor, α1PI) in HIV Disease

Start date: April 2012
Phase: Phase 2/Phase 3
Study type: Interventional

Our primary objective is to further characterize the mechanism by which alpha-1PI regulates CD4 counts. HIV-1 infected patients will be initiated on PROLASTIN®-C (Alpha-1 Proteinase Inhibitor [Human], Grifols Biotherapeutics Inc.) or placebo. Uninfected volunteers will be untreated and will be monitored for comparison.

NCT ID: NCT01692236 Terminated - Clinical trials for Human Immunodeficiency Virus

Brain Imaging for HIV-Associated Thinking and Mood Disorders

Start date: September 13, 2012
Phase:
Study type: Observational

Background: - Human immunodeficiency virus (HIV) infection appears to cause problems with blood vessel function. These problems may add to some thinking and mood disorders found in people with HIV infection. Researchers want to evaluate HIV infected patients to see if blood vessel function contributes to thinking and mood disorders, such as early dementia and depression. To do so, they will compare study results between people with and people without HIV infection. Objectives: - To compare the thickness of blood vessel walls between people with and without HIV infection. - To study the relationship between blood vessel thickness and thinking and mood disorders. Eligibility: - Individuals between 25 and 55 years of age who have HIV infection. - Healthy individuals between 25 and 55 years of age. Design: - Participants will be screened with a physical exam and medical history. Blood and urine samples will be collected. - Participants will have imaging studies of the brain and major blood vessels in the head and neck. - Participants will also have neuropsychological testing. These tests will look at memory, learning and thinking ability, attention, and mood. - Participants will have the option of coming back for repeat blood tests every six months and repeat imaging studies and neuropsychological tests every year, over 1- 4 years period.

NCT ID: NCT01676363 Terminated - HIV Infection Clinical Trials

Pilot Study of Diflunisal in HIV-infected Adults

Start date: March 2013
Phase: Phase 4
Study type: Interventional

Diflunisal is an anti-inflammatory drug (like ASA or ibuprofen) that has been used as a painkiller for 20 years. Recent research shows that it may have an anti-HIV effect in the laboratory. Approximately 20 HIV-infected adults who are not receiving antiretroviral therapy will be given diflunisal by mouth twice daily for 4 weeks, at a dose that has been shown to be safe when used to treat pain. Subjects will be monitored closely for safety and will have frequent blood tests during the study to see if the drug has any effect on the level of HIV in their blood.

NCT ID: NCT01601626 Terminated - Tuberculosis Clinical Trials

Rifampin-Based Tuberculosis Treatment Versus Rifabutin-Based Tuberculosis Treatment in Persons With HIV

Start date: July 13, 2013
Phase: Phase 2
Study type: Interventional

There is a rapidly-growing need to identify evidence-based, safe, and effective co-treatment regimens for HIV-related tuberculosis (TB) among patients who require protease inhibitor (PI)-based antiretroviral therapy (ART). This study compared three alternative co-treatment options among participants in high TB endemic resource-constrained settings, in which one co-treatment option explores if an additional anti-HIV drug needs to be used when patients are being treated with a PI together with rifabutin-based anti-TB treatment.

NCT ID: NCT01583439 Terminated - HIV Infections Clinical Trials

The Mochudi Prevention Project ART Protocol

Start date: September 2012
Phase: N/A
Study type: Interventional

The goal of the "Mochudi Prevention Project" is to reduce the number of new HIV infections in the village of Mochudi, Botswana by promoting a comprehensive package of interventions that have proven to be effective in preventing the spread of HIV. This antiretroviral treatment (ART) clinical study is nested within the Mochudi Prevention Project, and is being conducted in the north-east segment (NES) of the village of Mochudi. The ART intervention component of the Mochudi Project is designed to determine the uptake of, adherence to, and feasibility of 3-drug combination ART as a component of a package of transmission prevention strategies. The hypotheses are 1) that ART (with 3 antiretrovirals from two classes of drugs) among participants with CD4 ≥ 250 cells/mm3 and VL ≥ 50,000 cp/mL will be acceptable and safe and 2) Eighty percent of eligible participants will agree to start 3-drug ART.

NCT ID: NCT01547754 Terminated - Clinical trials for HIV-Associated Cognitive Motor Complex

Mild Neurocognitive Disorder in HIV Infection of the Brain

Start date: January 9, 2012
Phase:
Study type: Observational

Background: - Some people with human immunodeficiency virus (HIV) develop problems with thinking and concentration when the virus affects the brain. This is known as mild neurocognitive disorder (MND). Research has shown that some HIV medications do not get through the blood brain barrier very well. P-glycoprotein (P-gp) is a brain protein that is part of the blood brain barrier. Differences in the activity of P-gp may help explain why some people with HIV develop MND. It is also possible that MND is partly due to inflammation in the brain. Researchers want to study P-gp and its effect on MND and HIV infection. Objectives: - To study P-gp and brain inflammation related to HIV infection. Eligibility: - Individuals between 18 and 60 years of age who have HIV and either do or do not have MND. - Healthy volunteers between 18 and 60 years of age. Design: - Participants will be screened with a medical history and physical exam. Blood and urine samples will be collected. - Participants will have one outpatient visit and one 3-day inpatient stay. - At the outpatient visit, participants will provide blood samples and have a lumbar puncture (spinal tap). The spinal tap will collect cerebrospinal fluid for study. - At the inpatient visit, participants will have two positron emission tomography (PET) scans of the brain. These scans will study brain activity and possible inflammation. One scan will involve a study drug called tariquidar, which blocks the activity of P-gp. A second lumbar puncture will be done before the first PET scan. Blood and urine samples will be collected daily.

NCT ID: NCT01489046 Terminated - HIV-1 Infection Clinical Trials

Safety, Efficacy and Dose-response Study of BMS-986001 in Subjects With HIV-1 Infection Who Are Treatment-naive

Start date: February 2011
Phase: Phase 2
Study type: Interventional

The purpose of this study is to identify at least one dose of BMS-986001 which is safe, well tolerated, and efficacious when combined with Efavirenz (EFV) + Lamivudine (3TC) for treatment-naive Human Immunodeficiency Virus 1 (HIV-1) infected subjects

NCT ID: NCT01448486 Terminated - Clinical trials for Human Immunodeficiency Virus (HIV)

A Study of the Neurological Effects of Adding Raltegravir to HAART Regimen in Patients With HIV

HANDral
Start date: October 2011
Phase: Phase 4
Study type: Interventional

HIV related cognitive impairment still occurs despite highly active antiretroviral therapy (HAART). HIV disease affects the brain in 20-40% of patients with advancing HIV disease leading to varying degrees of cognitive impairment, recently termed HIV associated neurocognitive disorders (HAND). HAND may occur in patients who are virally suppressed in both blood and CSF. Patients with HIV Associated Neurological Disorders (HAND) who are virally suppressed in both their blood and cerebrospinal fluid (CSF), whilst on a highly active antiretroviral therapy (HAART) regimen may have significant cognitive improvement with HAART intensification with the medication Raltegravir; compared to those who remain on their existing regimen. This study will be a prospective, interventional, randomised and unblinded controlled clinical trial. The aim of this study will be to determine whether HAART intensification with the medication Raltegravir, leads to significant improvement in HIV associated neurological disorders (HAND). Patients with the recent progression (within 6 months) of HAND (validated by neuropsychological assessment) on HAART who are virally suppressed (<50 copies per ml) in blood and CSF will be randomised to have their existing HAART regimen intensified with raltegravir 400mg twice daily, or not. The control arm will remain on their medication regimen as prescribed. The target is to enrol 110 patients into the control group, and 110 patients into the Raltegravir intensification group. Patients will undergo baseline neuropsychological testing, MRI, blood tests, and cerebral spinal fluid (CSF) tests (via a lumbar puncture). The methods used to determine the effectiveness of adding Raltegravir, will include further neuropsychological testing at 6 months; and neuropsychological testing, MRI and CSF assessment at 12 months. Neuropsychological testing completed at 6 and 12 months will be completed by a "blind assessor", in that they will have no knowledge of which arm (treatment or control) the participant is enrolled in. An evaluation (neuropsychological testing) will be performed should the patient deteriorate during the course of the study, as recognised by the patient's managing physician. The decision of the Antiretroviral medication regimen to be used in such a case will be determined by the managing physician. At the end of the study protocol (12 months) the patient's HAART therapy will be managed by their primary physician.

NCT ID: NCT01420523 Terminated - Clinical trials for Human Immunodeficiency Virus

Evaluation of Raltegravir Plus Maraviroc Therapy in Controlled HIV Patients Presenting With Lipohypertrophy

ROCnRAL
Start date: December 2011
Phase: Phase 2
Study type: Interventional

Evaluation of antiretroviral therapy combining Raltegravir and Maraviroc in patients with virological success, presenting with clinical lipohypertrophy.