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Coinfection clinical trials

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NCT ID: NCT02964767 Completed - HIV Clinical Trials

HIV-Tb Confections Among HIV Patients

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

A cross sectional study would be done for prevalence of HIV-Tb. co infection among patients of HIV enrolled at ART centre, Khagaria, India, during June' 2015 to May' 2016. A comparative study of CD4 (cluster of differentiation 4) T cell count among HIV-Tb. co infected patient and HIV patients would be taken in account.

NCT ID: NCT02938013 Completed - HIV Clinical Trials

deLIVER: Direct Acting Antiviral Effects on the Liver

deLIVER
Start date: January 2017
Phase: Phase 4
Study type: Interventional

Open-label, partially-randomized plasma and liver sampling study to assess hepatitis C virus (HCV) kinetics during treatment with two (Sofosbuvir/Velpatasvir) or three (Sofosbuvir/Velpatasvir/Voxilaprevir) direct acting antivirals (DAAs)

NCT ID: NCT02810275 Completed - HIV Infection Clinical Trials

Folinic Acid: Supplementation and Therapy

FAST
Start date: October 2012
Phase: Phase 3
Study type: Interventional

Patients infected by HIV or HIV-HCV coinfected have higher survival due to the use of HAART, but survival is accompanied by increased morbidity and associated cardiovascular disease (CVD). Endothelial dysfunction is an early marker of atherogenesis, acting as an intermediate in the causal pathway of CVD. Folinic acid (FA) has been shown to reduce CVD outcomes, especially among individuals with hyperhomocisteinemia. To date, few studies provided consistent information about efficacy of pharmacological interventions that minimize damage to the vascular endothelium in patients infected by HIV or HIV-HCV coinfected. The main hypothesis of this study is that FA supplementation protects the vascular endothelium, and consequently might prevent subclinical atherosclerosis. Thus, the first step is to determine the efficacy of supplementation with FA, and to compare the effect between HIV and HIV-HCV coinfected.

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: 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: NCT02660905 Completed - Clinical trials for Hepatitis C, Chronic

HIV Drug Switch Followed by HCV Therapy in HIV-HCV Co-Infection

CTN289
Start date: April 2016
Phase: Phase 3
Study type: Interventional

This is an prospective open label pilot study conducted over 32 weeks. A total of 25 eligible participants who are infected with HCV and HIV will be recruited from 2 Canadian HIV Trials Network (CTN) sites (Ottawa Hospital Research Institute and McGill University Health Centre) This study is investigating the effectiveness of a combination of Elvitegravir/Cobicistat/Emtricitabine/ Tenofovir Alafenamide Single Tablet Regimen (E/C/F/TAF STR) for HIV treatment and Harvoni for HCV treatment. This study will assess the effect that the study drug has on the metabolism of sugar, the changes in fat in the bloodstream, and other metabolic changes. Metabolism is the process your body uses to get or make energy from the food you eat. This study may provide information on the impact of liver fibrosis (scarring of liver tissues) on metabolic changes before, during and after HCV antiviral therapy. Drug-drug interactions (DDI) between E/C/F/TAF and LPV-SOF have been well evaluated and no clinically significant interactions have been identified. A switch to E/C/F/TAF in the context of LPV-SOF HCV antiviral treatment preparation may be particularly beneficial because of its: 1. favorable side effect profile 2. once daily STR formulation 3. known DDI profile with LPV-SOF 4. neutral effect on liver fibrosis 5. improved kidney and bone safety profile with the use of TAF Conduct of this study is justified as it: 1. Assesses a minimal pill count and dosing frequency strategy of co-treatment of HIV and HCV using well tolerated medications with an excellent safety profile and known DDI profile. 2. Provides additional safety data for TAF in the HIV-HCV co-infected population. 3. Quantifies adherence and identifies obstacles to full adherence in this population. There is a paucity of data related to DAA adherence in licensing studies. 4. Provides real-world safety and efficacy data to support the public funding for LPV-SOF DAA therapy in HIV-HCV co-infected populations. 5. Provides preliminary data on the immunologic and metabolic consequences of HCV clearance in HIV-HCV co-infection 6. As a pilot study, the information gathered will inform the feasibility of future clinical trials evaluating novel treatment strategies for HIV-HCV co-infected patients.

NCT ID: NCT02625909 Completed - Hepatitis C Clinical Trials

Randomised Study of Interferon-free Treatment for Recently Acquired Hepatitis C in PWID and People With HIV Coinfection.

REACT
Start date: March 9, 2017
Phase: Phase 3
Study type: Interventional

The aim of the study is to determine if treatment for recently acquired hepatitis C infection (with or without HIV coinfection) can be shortened when treating with the interferon-free therapy sofosbuvir/velpatasvir (SOF/VEL). SOF/VEL is a new treatment for hepatitis C called direct acting antiviral which targets the hepatitis C virus replication cycle and has been shown in phase II studies in chronic HCV to be highly effective (SVR12 >95%) when given for 12 weeks. Data has shown that treatment can be shortened when treating recently acquired HCV with interferon containing treatments. It is not known whether treatment with SOF/VEL can be shortened. This study aims to find out if treatment for 6 weeks with open-label SOF/VEL is equivalent to treatment for 12 weeks with SOF/VEL in participants with recently acquired hepatitis C infection. The project is a randomised study where both participants and investigators would not find out the treatment duration of the participants until week 6 of treatment.

NCT ID: NCT02613871 Completed - Clinical trials for Hepatitis C Virus Infection

Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed-Dose Combination in Adults With Chronic HCV and HBV Coinfection

Start date: December 22, 2015
Phase: Phase 3
Study type: Interventional

The primary objectives of this study are to determine the antiviral efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) in adults with chronic genotype 1 or 2 HCV infection who are coinfected with HBV in Taiwan.

NCT ID: NCT02588287 Completed - Clinical trials for Hepatitis C and HIV Coinfection

Effects of Sofosbuvir/Ledipasvir Treatment on the Pharmacokinetics and Renal Safety of Tenofovir

Start date: November 2015
Phase: N/A
Study type: Interventional

This study evaluates the effect of sofosbuvir/ledipasvir (SOF/LDV) treatment on the pharmacokinetics (PK) and renal safety of tenofovir. Subjects receiving tenofovir-based antiretroviral therapy with human immunodeficiency virus (HIV) protease inhibitors (HIV PI/r) and initiating SOF/LDV treatment for Hepatitis C virus (HCV) will be invited to participate. The study consists of three visits: a screening visit and two abbreviated 4-hour pharmacokinetic visits (one before initiating SOF/LDV and a second approximately 4 weeks after initiating SOF/LDV).

NCT ID: NCT02555943 Completed - Clinical trials for Chronic Hepatitis C Infection

DAAs Treatment for Chronic HCV/HBV Co-infection Patients(DASCO)

DASCO
Start date: February 2015
Phase: Phase 2/Phase 3
Study type: Interventional

This is a prospective study to determine the incidence, morbidity, mortality and predisposing factors for the reactivation of hepatitis B virus replication during direct anti-HCV treatment of HCV/HBV co-infection patients.