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Coinfection clinical trials

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NCT ID: NCT03115736 Completed - Clinical trials for HIV and Hepatitis B Coinfection

TAF for HIV-HBV With Renal Dysfunction

Start date: May 23, 2017
Phase: Phase 2
Study type: Interventional

The investigators aim at describing changes in renal glomerular and tubular function with after the switch from TDF to TAF in HIV/HBV-coinfected patients with mild to moderate renal dysfunction and to assess the virological efficacy of TAF on HBV infection. The study will include HIV/HBV-coinfected participants of the Swiss HIV Cohort Study (SHCS) who are under active care and have been on a stable, TDF-containing ART regimen for at least 6 months. Only patients with an estimated glomerular filtration rate (GFR) between 30 ml/min and 90 ml/min will be included. All individuals who agree to participate will be switched from a TDF-containing ART regimen to a TAF-containing triple ART regimen at week 0 and will be followed for 48 weeks after the treatment change.

NCT ID: NCT03098121 Completed - Chronic Hepatitis C Clinical Trials

Efficacy and Tolerability of Grazoprevir and Elbasvir in Patients With Chronic Genotype 1 HCV and HIV Co-infection

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

This clinical study will evaluate whether grazoprevir and elbasvir is efficacious, safe, and well-tolerated in peginterferon alfa plus ribavirin experienced patients who inject drugs (PWID) and men who sex with men (MSM) with genotype 1 HCV and HIV co-infection.

NCT ID: NCT03050905 Completed - HCV Coinfection Clinical Trials

Proof of Concept Study To Evaluate the Efficacy and Justification Of OBV/PTV/r and DSV In Adults With Chronic Hepatitis C Virus Genotype 2K/1B

Start date: June 22, 2017
Phase: Phase 4
Study type: Interventional

HCV infection is one of the most prevalent etiologies for liver cirrhosis and hepatocellular carcinoma. HCV is highly heterogeneous, with seven confirmed major genotypes. Each genotype displays a different geographic distribution. Since different HCV genotypes react differently on available antiviral therapies, the correct identification of HCV genotype serves as a marker of responsiveness and an indicator for duration of treatment. The recombinant HCV genotype 2k/1b was first described in Saint Petersburg in 2002. A sequencing strategy led to the detection of HCV genotype 2k/1b. However, clinical laboratories often use the VERSANT HCV Genotype 2.0 Assay for routine HCV genotyping. This assay may potentially misclassify these HCV strains as genotype 2a/2c. Based on these findings, the number of patients with 2k/1b may be underestimated. AbbVie's IFN-free regimen for the treatment of chronic HCV genotype 1b infection includes 3 DAAs with distinct mechanisms of action and non-overlapping resistance pattern to target HCV proteins essential for viral replication. The high efficacy of the 3D regimen was proven in registration clinical trials and RW for 1b population. 3D regimen has not been evaluated for patients with HCV genotype 2K/1B. Primary Objective • Evaluate the efficacy of ombitasvir/paritaprevir/ritonavir and dasabuvir (3D) in an interferon-free treatment regimen as assessed by SVR in adult patients with HCV 2k/1b. Study Design: .The study will include 1 group. Patients with HCV GT 2k1b will be treated according to label recommendation as for GT1b (with and without cirrhosis) for 12 weeks. All subjects will receive Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir. Subjects will be assessed for antiviral response, clinical outcomes, patient reported adverse events and presence and emergence of resistance associated variants. Subjects will be followed for up to 12 weeks of treatment and extra 24 weeks of follow up. Scheduled visits will include: physician assessment and blood tests including HCV resistance mutations.

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: NCT02830230 Not yet recruiting - Clinical trials for Cervical Inflammation and Human Papilloma Virus Performance

"Performance of HPV DNA Test in Presence of Co-infection With Common RTIs"

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

There is a strong causal association between persisting genital tract infection with Human Papilloma Virus (HPV) and gradual progression of infection to cervical (mouth of uterus) cancer.The robust study from India have shown that single round of HPV DNA screening test to significantly reduce the cervical cancer mortality. The above findings are very encouraging since it demonstrates that a simple and reliable HPV DNA test which is now available in low income countries has a potential to be accepted as primary screening test in future. The cross-sectional studies from developed countries from year 1999-2004 which focused to determine the test characteristics of HPV Hybrid Capture 2 test (HC2) to determine CIN2 and higher grade lesions, reported test sensitivity of 90% to 100% with a mean of 95%. Similarly the cross-sectional studies from developing countries from 1993 to 2003 which have focused on test characteristics of HPV DNA Hybrid capture 2 (HC2) test to determine CIN2 and higher grade lesions has shown a sensitivity in the range of 50% to 91% with an average sensitivity of 79%.Among the developing countries cross-sectional study from India which evaluated test reported sensitivity of only 68.2%. There is a statistical significant difference ( p value = 0.003) of sensitivity of HPV DNA HC2 test between the developed and developing countries to determine CIN2+ Lesions while there is no difference in the specificity. A study that was conducted in Chinese women to detected the prevalence of HPV genotype among women with mucopurulent cervicitis, healthy women and women with Invasive cancer, the author reported a 10% higher failure rates to extract HPV DNA in cases of mucopurulent cervicitis as compared to other two groups. So the study will explore if if the presence of untreated co-infections with STIs/RTIs (Sexually transmitted infections/Reproductive tract infections) resulting in cervical inflammation is somewhere interfering with low sensitivity of HC2 test due to presence of blood and excess mucus associated with the conditions leading to low sensitivity of the test in context to Indian Scenario.

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: NCT02762383 Terminated - HIV/HCV Coinfection Clinical Trials

Pegasys Long-Term Anti-Fibrotic Effect Co-Infection Trial (PERFECT)

Start date: March 2005
Phase: Phase 3
Study type: Interventional

This is an uncontrolled, open-label, Phase III trial of peginterferon alfa-2a (Pegasys) in participants coinfected with human immunodeficiency virus (HIV) and hepatitis C virus (HCV). Participants with HIV/HCV who do not show negative or reduced HCV ribonucleic acid (RNA) after at least 12 weeks of treatment with peginterferon alfa-2a plus ribavirin will receive a low dose of peginterferon alfa-2a for 18 months. The primary objective is to evaluate safety and tolerability. Secondary objectives are to evaluate histological, virological, and biochemical effects.

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: 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.