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NCT ID: NCT02707991 Completed - HIV Clinical Trials

Nurse Case Management to Improve Hepatitis C Care in HIV Co-infection

Care2Cure
Start date: July 2016
Phase: N/A
Study type: Interventional

Effective all-oral medications are finally available to cure hepatitis C virus, which affects more than 4 million Americans and one-in-four people living with HIV. However, many barriers exist that prevent people with HIV/HCV co-infection from getting this curative treatment, including low knowledge, competing demands, and drug interactions with HIV medications. This study evaluates if a hepatitis C nurse case management intervention in an HIV primary care clinic will improve patient attendance to hepatitis C care and help people start hepatitis C treatment earlier. Half of the participants will receive brief case management with a nurse, while the other half will receive usual clinic care.

NCT ID: NCT02707861 Completed - HIV Clinical Trials

Ibalizumab Plus Optimized Background Regimen in Treatment-Experienced Patients With Multi-Drug Resistant HIV-1

Start date: March 2016
Phase: Phase 3
Study type: Interventional

Ibalizumab is a monoclonal antibody that works by blocking HIV entry into the immune system cells (CD4+ or T-cells) the virus typically infects. Ibalizumab is intended for use in combination with other anti-HIV drugs in people with multi-drug resistant HIV and limited treatment options. This study will collect further information on the safety and tolerability of intravenously administered (IV) ibalizumab combined with an optimized background regimen for treating multi-drug resistant HIV-1 infection, and will provide continuing access to ibalizumab for patients completing a prior ibalizumab clinical trial.

NCT ID: NCT02707692 Completed - HIV Clinical Trials

Perturbing of HIV Reservoir With Immune Stimulation

Start date: August 2016
Phase: N/A
Study type: Interventional

The purpose of this study is to determine the impact of Pneumococcus and Influenza vaccines on the HIV transcriptional activity in individuals who are virologically suppressed for at least 48 weeks on similar ART. The proposed study is a randomized double-blinded control trial conducted over 28 weeks. Randomized interventions will be injections of Influenza vaccine, Pneumococcal vaccine, and Placebo. Each participant will receive each injection but in a randomized order.

NCT ID: NCT02704208 Completed - HIV Clinical Trials

A Technology-Delivered Peer-to-Peer Support ART Adherence Intervention for Substance-using HIV+ Adults

TWM
Start date: October 1, 2016
Phase: N/A
Study type: Interventional

The "Thrive With Me" (TWM) trial is testing the efficacy of a mobile enhanced website aimed at improving Antiretroviral Therapy (ART) adherence for HIV-positive men who have sex with men (MSM). TWM is a technology-delivered peer-to-peer social support intervention with social networking and gaming components. In addition to real-time peer-to-peer support capabilities, the TWM intervention provides participants with Antiretroviral Therapy (ART) adherence self-monitoring tools, medication dose reminders, and HIV-related informational content.

NCT ID: NCT02703116 Completed - HIV Clinical Trials

Employing eSBI in HIV Testing for At-risk Youth

Start date: August 2016
Phase: N/A
Study type: Interventional

The purpose of this study is to assess the feasibility, acceptability and test the initial efficacy of eSBI, (electronic screening and brief intervention for alcohol use) coupled with STTR (Seek, Test, Treat, and Retain) in comparison to STTR only among YMSM (young men who have sex with men) and YTW (young transgender women) on frequency of substance use and engagement within the HIV (human immunodeficiency virus) and PrEP (pre-exposure prophylaxis) care continuum.

NCT ID: NCT02699736 Enrolling by invitation - Clinical trials for Cardiovascular Diseases

EuroSIDA - Clinical and Virological Outcome of European Patients Infected With HIV

EuroSIDA
Start date: January 1994
Phase:
Study type: Observational [Patient Registry]

The EuroSIDA study is a prospective observational cohort study of 23,000+ patients followed in 100+ clinics in 35 European countries, Israel and Argentina. The study is the largest pan-European cohort study and few studies of a comparable design are available on a global scale. The EuroSIDA study is an ongoing collaboration and patients have been enrolled into the study through 11 cohorts since 1994. The main objective of the study remains the same as in 1994: to prospectively study, clinical, therapeutic, demographic, virological and laboratory data from HIV-1 positive persons across Europe in order to determine their long-term virological, immunological and clinical outcomes. Historically, EuroSIDA has been crucial in reporting key changes in the HIV epidemic, such as the dramatic changes in morbidity and mortality when combination anti-retroviral therapy (cART) was first introduced. As new anti-HCV treatment is introduced to HIV/HCV co-infected patients, it is important for EuroSIDA to remain in the forefront of investigating the treatment benefits and adverse effects. All study documents, study status, newsletters, scientific publications and presentations are available online and are updated continuously at project website. In general terms, the objective of the EuroSIDA study is to continue a long-term, prospective collection of clinical, laboratory and therapeutic data as well as plasma on a large cohort of consecutive HIV infected patients from across Europe in order to (1) assess the factors associated with the clinical, immunological and virological course of HIV infection and HIV-related co-infections and co-morbidities, and (2) continue to provide and develop a surveillance system to describe temporal changes and regional differences in the clinical course of HIV and HIV-related co-infections and co-morbidities in Europe.

NCT ID: NCT02697851 Terminated - HIV Clinical Trials

Pharmacokinetic Effect of Evotaz/Microgynon Co-administration

Start date: July 2016
Phase: Phase 1
Study type: Interventional

This study will investigate the pharmacokinetic of evotaz (atazanavir/cobicistat) and microgynon (ethinylestradiol/levonorgestrel ) when administered alone and together. There will be two study arms, who will take the medications in different orders: GROUP 1: Microgynon 30® for 21 days, Followed by Microgynon 30® for 21 days plus Evotaz® for 14 days, Followed by Evotaz® for 14 days GROUP 2: Evotaz® for 14 days followed by 7 days wash-out, Followed by Microgynon 30® for 21 days plus Evotaz® for 14 days, Followed by Microgynon 30® for 14 days (participants may chose to complete a 21 day pack). The total duration of the study is 57 days (+screening and follow up visits) and patients will have 3 intensive pharmacokinetic days on days 14, 35 and 56.

NCT ID: NCT02693847 Completed - HIV Clinical Trials

Natural History of Liver Cirrhosis Diagnosed by Transient Elastography in HIV/HCV-coinfected Patients

Start date: February 2006
Phase:
Study type: Observational [Patient Registry]

Prospective multicenter cohort recruiting consecutive patients from 7 hospitals in Andalusia, southern Spain, according to following criteria: 1) HIV infection, 2) Chronic active HCV infection, 3) Older than 18 years, 4) New diagnosis of liver cirrhosis on the basis of a liver stiffness above 14 kiloPascals, 5) No previous or concomitant decompensation of liver disease. Patients are prospectively followed-up according to a uniform protocol of care. Epidemiological, clinical and laboratory variables are periodically recorded. The primary outcomes are the emergence of a liver decompensation (including hepatocellular carcinoma), liver transplant or death. The predictors of these outcomes are analyzed.

NCT ID: NCT02692274 Completed - HIV Clinical Trials

Operational Assessment of Point-of-Care Diagnostics in Primary Healthcare Clinics

Start date: April 2015
Phase: N/A
Study type: Observational

Diagnostic point-of-care (POC) tests are being rapidly developed and implemented in resource-limited settings. There has been a rapid rise of HIV and TB POC tests in South Africa during the last 10-15 years. The investigators sought to determine the existing availability, current usage and future need of POC tests among rural primary healthcare (PHC) clinics in South Africa's KwaZulu-Natal Province.

NCT ID: NCT02691065 Completed - HIV Clinical Trials

Protease Inhibitor vs. Raltegravir-based ART and Inflammation in HIV Infection

Start date: January 20, 2017
Phase: Phase 4
Study type: Interventional

Human immunodeficiency virus (HIV) infection damages body defence mainly by affecting two important white blood cells called cluster of differentiation (CD4) T cells and monocytes. This immune dysfunction leads to persistent inflammation, which is partially resolved with long-term anti-HIV therapy. Importantly, such inflammation increases risk for cardiovascular, diabetes, and kidney diseases. The causes of this inflammation are largely unknown and include HIV itself, presence of other infections, lifestyle characteristics like increased cholesterol levels, obesity, smoking and alcohol abuse. In addition, inflammation can be driven by certain type of anti-HIV therapy called protease inhibitor (PI). PI has been associated with an increase of cholesterol and may contribute to inflammation. A new class of medication that is now available in Canada called integrase inhibitor (II) may have a lesser or no effect on cholesterol levels. Therefore, it is important to study the effect of II on cholesterol levels and inflammation. The purpose of this study is to assess the inflammatory changes, in the blood of persons treated with PI that will switch to the II or may remain on their PI-containing regimen. By comparing persons continuing their current PI-based regimen with those who switch to II-based regimen, we will know if the change from PI to raltegravir (Isentress), a type of II, decreases lipids and inflammatory markers. The adult persons living with HIV, who are on PI-based therapy for more than a year, with any CD4 T cell count and plasma viral load below level of detection, will be invited to participate in the study. 40 study participants will be selected by randomization (like a toss of a coin) to either continue PI-based regimen (20 participants) or switch to raltegravir-based regimen (20 participants) for a period of 12 months. Blood samples of the study participants will be drawn before, during and at the end of study to evaluate changes in markers of inflammation, cholesterol level and CD4 T cell and monocyte function. No experimental anti-HIV medication will be used; change of therapy will include raltegravir which is one of currently recommended medications to treat HIV in Canada. This study will be able to answer this important question whether inflammation can be decreased by switching therapy from PI-based therapy to raltegravir-based therapy. Ultimately, information provided by this study will contribute to the health of persons living with HIV.