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HIV Infections clinical trials

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NCT ID: NCT02501486 Recruiting - Clinical trials for Adrenal Insufficiency

Inhalation/Nasal Corticosteroids and Prevalence of Hypothalamic-pituitary-adrenal (HPA) Axis Suppression in Human Immunodeficiency Virus (HIV)-Patients

Incorporate
Start date: July 2015
Phase: N/A
Study type: Interventional

Rationale: Case reports describe suppression of the hypothalamic-pituitary-adrenal (HPA) axis caused by local corticosteroids, most often with inhalation corticosteroids. The exact prevalence is not known. Early recognition is important, because suppression of the HPA-axis can lead to significant morbidity and mortality. Suppression of the HPA axis might occur more often when a Cytochrome P450 3A4 (CYP3A4) inhibitor, e.g. ritonavir, is used next to the local corticosteroid, a combination often used by human immunodeficiency virus (HIV)-patients. Cortisol can be determined in hair. This non-invasive analysis could help in diagnosis of suppressed HPA-axis. Research questions: Primary objective: 1. How often do inhalation or nasal corticosteroids lead to suppression of the HPA- axis in HIV-treated patients? Secondary objectives: 2. Are other variables associated with the HPA-axis suppression? 3. Are cortisol measurements in hair as reliable as serum cortisol or an Adrenocorticotropic hormone (ACTH) stimulation test to diagnose suppression of the HPA axis? Study design: cross-sectional explorative study Study population: adults treated for HIV and using an inhalation or nasal corticosteroid. Intervention: an ACTH stimulation test, cortisol measurements in blood and hair. Main study parameters/endpoints: Proportions of persons with a low morning plasma cortisol or low cortisol after an ACTH stimulation test. Correlation between cortisol in plasma and hair cortisol. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Each person will be screened with a history and a short physical examination. A venous cannula will be inserted for obtaining blood for the plasma cortisol and for the ACTH stimulation test. An ACTH stimulation test has no major complications. A piece of hair is cut for cortisol hair analysis. The risks and burden are minimal, while the future benefits could be great since suppression of the endogenous HPA- axis can be associated with morbidities like hypertension or osteoporosis and can even lead to an adrenal crisis when the local corticosteroid is stopped.

NCT ID: NCT02481622 Recruiting - Clinical trials for HIV Infection of the Uterine Vaginal Tissues

First Event of Infection by HIV-1 of Uterine Vaginal Tissue

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

This non-interventional study aims to characterize the cells infected with HIV over time in different types of vagino-uterine tissue.

NCT ID: NCT02479698 Recruiting - Clinical trials for Human Immunodeficiency Virus

Cytotoxic T Lymphocytes in Treating Patients With Malignancies With BK and/or JC Virus

Start date: July 23, 2015
Phase: Phase 2
Study type: Interventional

This phase II trial studies how well donor cytotoxic T lymphocytes work in treating patients with malignancies with BK and/or JC virus. Cytotoxic T lymphocytes are made from donated blood cells that are grown in the laboratory and are designed to kill viruses that can cause infections in transplant patients and may be an effective treatment in patients with malignancies with BK and/or JC virus.

NCT ID: NCT02392884 Recruiting - Clinical trials for Human Immunodeficiency Virus

HIV Medication Adherence in Underserved Populations

Start date: September 2014
Phase: N/A
Study type: Interventional

The purpose of this study is to determine whether cognitive rehabilitation or psychoeducation impacts medication adherence in HIV-1 seropositive individuals.

NCT ID: NCT02266992 Recruiting - Clinical trials for Acquired Immune Deficiency Syndrome Virus

Exploring Novel Mechanisms of Vaccine Failure LAIV Pilot Study

LAIV
Start date: September 2014
Phase: Phase 2
Study type: Interventional

Influenza ('flu) can cause severe infections, especially in people with weakened immune systems such as those with HIV. For this reason, yearly vaccination is recommended with the standard 'inactivated' influenza vaccine to try and prevent infections in these populations. It is also recommended in all health care workers, to help prevent the spread of influenza within healthcare settings. However, having HIV infection may mean vaccines work less well in some people and the investigators do not completely understand why. An alternative to the standard 'inactivated' annual influenza vaccine is the 'live attenuated influenza vaccine' (LAIV), which means it consists of weakened versions of the influenza virus. Unlike the standard vaccine, which is given by injection, LAIV is a spray that is given into each nostril. It is now given to children in the UK in preference to the standard vaccine as it results in greater protection from influenza. In some other countries, like the USA, adults are also given LAIV, where it seems to work just as well as the standard vaccine. A few studies in the past have shown that LAIV is safe and effective in HIVinfected children and adults. The investigators want to give LAIV to HIVinfected and HIV negative individuals, to try to find out new information about how HIV infection may change the way in which people respond to vaccines. The investigators will do this by comparing both the early genetic response to the vaccines and later responses from cells specifically targeted to fight influenza ('Tcells'), in these groups. In the long term, the investigators hope that this will lead to designing new ways of improving the response to vaccines in HIVinfected people. As LAIV is given into each nostril, rather than an injection, the investigators also want to see if LAIV results in Tcells in the lung that are specifically targeted to fight influenza

NCT ID: NCT02140255 Recruiting - HIV Infection Clinical Trials

Very Early Intensive Treatment of Infants Living With HIV to Achieve HIV Remission

Start date: January 23, 2015
Phase: Phase 1/Phase 2
Study type: Interventional

The study will explore the effects of early intensive antiretroviral therapy (ART) with or without a broadly neutralizing antibody (bNAb) on achieving HIV remission (HIV RNA below the limit of detection of the assay) among infants living with HIV.

NCT ID: NCT02119702 Recruiting - HIV/AIDS Clinical Trials

Adolescent Master Protocol for Participants 18 Years of Age and Older (AMP Up)

AMP Up
Start date: April 2014
Phase:
Study type: Observational

This is a prospective cohort study designed to define the impact of HIV infection and antiretroviral therapy (ART) on young adults with perinatal HIV infection (YAPHIV) as they transition into adulthood. A group of of perinatally exposed but uninfected young adults from a similar sociodemographic background and age distribution will be enrolled for comparison.

NCT ID: NCT02057003 Recruiting - Clinical trials for Hepatitis C, Chronic

Real-life Security and Efficacy of DAA-based Therapy in HCV/HIV-Coinfected Patients

Start date: January 2012
Phase: N/A
Study type: Observational

The purpose of this study is to evaluate the efficacy and tolerability of DAA-based regimens in the clinical practice in HIV/HCV-coinfected patients. Hypothesis: The efficacy and tolerability of DAA-based regimens in the clinical practice is different to what is observed in clinical trials in HIV/HCV-coinfected patients.

NCT ID: NCT02035969 Recruiting - Clinical trials for Human Immunodeficiency Virus (HIV)

Assessment of Group Peer Support to Children With HIV in Vietnam

Start date: December 2013
Phase: N/A
Study type: Interventional

This project aims to assess the effect of group peer support to children with HIV in relation to adherence, virological treatment failure as well as physical development. A randomised controlled trial (RCT) will be used where HIV+ children on antiretroviral treatment (ARV) and their caretakers are randomized into either enhanced treatment support (ETS) through peer supporters or the conventional treatment (CT) according to the guidelines of The National AIDS Control Program. The treatment strategies will be assessed and compared in relation to virological treatment failure as primary endpoint, immunological and clinical (AIDS events and mortality) as secondary endpoints as well as treatment adherence and physical development. The results from this project will lead to an increased knowledge in relation to the impact of enhanced treatment support on adherence, virological suppression and resistance development for children with HIV and have an impact on HIV treatment policies and guidelines for Pediatric HIV in low-income settings globally.

NCT ID: NCT02016924 Recruiting - HIV Infections Clinical Trials

Study of Cobicistat-Boosted Atazanavir (ATV/co), Cobicistat-Boosted Darunavir (DRV/co) and Emtricitabine/Tenofovir Alafenamide (F/TAF) in Children With HIV

Start date: January 16, 2014
Phase: Phase 2/Phase 3
Study type: Interventional

The goal of this clinical study is to learn more about the safety and dosing of study drugs, cobicistat-boosted Atazanavir (ATV/co), cobicistat-boosted darunavir (DRV/co) and emtricitabine/tenofovir alafenamide (F/TAF), in children (age ≥ 4 weeks to < 18 years) with HIV.