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HIV Infections clinical trials

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NCT ID: NCT00958815 Completed - HIV Infections Clinical Trials

Human Atherosclerotic Plaque Inflammation Imaged Using PDG-PET/CT

Start date: March 2009
Phase: N/A
Study type: Observational

People with diabetes are at increased risk for atherosclerosis and have high CVD morbidity and mortality rates. Tools for detecting and quantifying atherosclerotic pro/regression in people with diabetes and other CVD risk factors lack sensitivity and specificity for molecular level events that occur during the early stages of atherogenesis. Inflammatory macrophage infiltration in the vessel endothelium is an early, molecular level proatherogenic event. Activated macrophages consume glucose at a high rate. Novel in vivo radiotracer PET/CT techniques have been developed to detect, image and quantify molecular level events like macrophage inflammation and glucose utilization (18FDG) in human vessels. We propose to develop and test this novel technique in the Center for Clinical Imaging Research (CCIR) at WUMS. We propose that HIV-infected people with significant CVD risk profiles are a suitable, unique human model for testing these novel imaging techniques. HIV-infected people taking anti-HIV medications develop insulin resistance, T2DM, dyslipidemia, central adiposity, and hypertension. HIV replicates in macrophages and represents a chronic proinflammatory condition. Recent data indicate that HIV+ CVD risk have greater risk for atherosclerosis and MI than HIV-negative people. To test feasibility, we hypothesize that: a.18FDG-PET/CT imaging will detect more macrophage glucose uptake and inflammation in the carotid and aorta arteries of HIV-infected people with CVD risk than in HIV-negative controls; b. radiotracer PET/CT measures of proatherogenic processes will correlate with carotid intima media thickness; a standard measure of carotid atherosclerotic burden. We propose to obtain pilot data that shows feasibility for a novel analytical approach that will expand capabilities for researchers interested in studying the links between diabetes, inflammation, and CVD in humans.

NCT ID: NCT00958100 Completed - HIV Infections Clinical Trials

Raltegravir Switch for Toxicity or Adverse Events

RaSTA
Start date: August 2009
Phase: Phase 2
Study type: Interventional

This study aims to verify the persistent control of the virus replication at 48 weeks after the simplification to tenofovir + emtricitabine + raltegravir or to lamivudine+abacavir+raltegravir in patients with optimal virological suppression without any virological failure to previous combined antiretroviral therapies needing a therapeutic switch for toxicity related issues or adverse events.

NCT ID: NCT00955968 Completed - HIV Infection Clinical Trials

IMPAACT 1077HS: Examining Benefits of HAART Continuation in Postpartum Women

Start date: January 1, 2010
Phase: Phase 4
Study type: Interventional

This study was a randomized strategy trial conducted among women who received highly active antiretroviral therapy (HAART) during pregnancy for purposes of prevention of mother-to-child transmission (PMTCT) of HIV but did not otherwise meet criteria to initiate HAART for their own health. The study was designed to determine whether continuation of HAART after delivery or other pregnancy outcome reduced morbidity and mortality compared to discontinuation and re-initiation of HAART when protocol specified criteria were met.

NCT ID: NCT00955006 Completed - HIV Infections Clinical Trials

Immune Response to an HIV DNA Plasmid Vaccine Prime Followed by Adenovirus Boost in HIV-uninfected Individuals

Start date: May 2011
Phase: Phase 1
Study type: Interventional

The purpose of the study is to determine the safety of mucosal immune responses to a DNA HIV vaccine followed by an adenoviral vector HIV vaccine in HIV uninfected adults.

NCT ID: NCT00954863 Recruiting - HIV Infections Clinical Trials

Genotypic Resistant HIV Strains in Taiwan

Start date: August 2009
Phase: N/A
Study type: Observational

Based on the investigators previous study, seventy-four of 786 HIV-1 isolates (9.4%), collected between 1999 to 2006, harbored one or more primary mutations associated with antiretroviral resistance to reverse-transcriptase inhibitors (RTIs) or protease inhibitors (PIs) in naïve patients. However, the drug resistance profiles for the HIV-1 integrase gene is unclear. Three objectives are proposed: 1. To investigate and compare the drug resistance profiles for the HIV-1 integrase gene between experienced and naive patients, who has not being exposed to Raltegravir. 2. To investigate and compare the drug resistance profiles for the HIV-1 integrase gene between different subtypes (subtype B, CRF01_AE and CRF07_BC). 3. To identify potential amino acid mutations in the integrase gene, which might affect the efficacy of Raltegravir.

NCT ID: NCT00952874 Completed - HIV Infections Clinical Trials

Molecular Biology of Anal Cancer in HIV-Positive Patients

Start date: July 2009
Phase: N/A
Study type: Observational

The molecular mechanisms involved in squamous cell carcinoma of the anus (SCCA) are poorly elucidated. HIV-positive and renal transplant patients are at high risk for developing SCCA, indicating that immune suppression plays a facilitating role. The investigators previously demonstrated that chromosomal instability (CIN) was more prevalent in SCCA of HIV-negative than HIV-positive patients. Hence, the investigators postulate that microsatellite instability (MSI), another molecular pathway, might be a feature of SCCA progression in the HIV-positive population. Study Aims: 1. to determine the prevalence of MSI in paraffin-embedded tumor specimen of 15 patients from the Swiss HIV cohort who underwent surgical excision for SCCA; and 2. eventually, to test our hypothesis by assessing the MSI status of SCCA in 15 recently operated HIV-negative patients. Study Design: The study is designed in two steps: 1. Firstly, the investigators will retrieve tumor specimen from 15 HIV-positive patients, with a biopsy-confirmed diagnosis of SCCA, in three institutions. DNA from tumor and normal tissues will be extracted, and then amplified by PCR. Presence of MSI in tumors will be determined by assessing the microsatellite markers BAT25, BAT26, and CAT25. 2. Secondly, the results of molecular analysis will be compared with a population of HIV-negative patients, with the same tumors, using the same detection technique for MSI.

NCT ID: NCT00951795 Withdrawn - HIV Infections Clinical Trials

Accuracy of the Pima™ CD4 Test for Enumeration of CD4+ T-Cell Counts

Start date: September 2009
Phase: N/A
Study type: Observational

This is a multi-center study designed to assess the accuracy of Pima™ CD4 Test to enumerate CD4+ T-cells in whole blood over the measurement range expected for the intended population. The Pima CD4 Test consists of the Pima™ CD4 cartridge and Pima™ Analyzer to identify and determine the absolute counts of mature helper (CD3+/CD4+) T-lymphocytes in whole blood.

NCT ID: NCT00951743 Recruiting - HIV Infections Clinical Trials

Safety and Efficacy of ADAPTAVIR's Ability to Eliminate Treatment-Resistant Infectious Virus in Peripheral Blood Mononuclear Cells (PBMCs)

Start date: July 2009
Phase: Phase 2
Study type: Interventional

This is a 24 week placebo controlled, double-blind, 2-arm study of ADAPTAVIR, Monomeric Dala1-peptide T-amide (mDAPTA) compared to placebo, in HIV infected individuals with suppressed plasma viral loads < 200 copies/ml by highly active antiretroviral therapy (HAART) treatment for at least 3 months prior to entry with at least 6 continuous months of HAART treatment preceding entry. 20 treatment and 20 placebo individuals will be enrolled in each arm. The study duration is 24 weeks on placebo or mDAPTA administered intranasally at 0.01 mg two times a day. The main (intent to treat) analysis is planned for the 24 week endpoint. The virological outcomes of interest in the present study are infectious virus recoverable from cellular (PBMC) sources and cellular viral mRNA and DNA copy numbers. Immune outcomes (plasma cytokines) associated with HIV disease, HIV replication, or immune function will be studied.

NCT ID: NCT00951249 Completed - HIV Infections Clinical Trials

Feasibility Study of a Multi-Component Intervention for Black Men Who Have Sex With Men

Start date: July 2009
Phase: N/A
Study type: Interventional

It has been estimated that black men who have sex with men (MSM) account for one quarter of all new HIV infections in the US annually, yet little prevention work has been directed towards this population. The purpose of this study is to research and potentially design a new and better way to try and slow the spread of HIV among black MSM.

NCT ID: NCT00951028 Completed - Depression Clinical Trials

Therapy Targeting Depression and HIV Treatment Adherence (The TRIAD Study)

Start date: September 2008
Phase: N/A
Study type: Interventional

This study will test a therapy for both helping people adhere to their HIV medication regimens and treating them for depression.