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Human Immunodeficiency Virus clinical trials

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NCT ID: NCT01855867 Completed - Clinical trials for Human Immunodeficiency Virus

HIV Non-Occupational Post-Exposure Prophylaxis

QUAD
Start date: May 2013
Phase: Phase 4
Study type: Interventional

The purpose of this study is to see if an anti-HIV medication known as Stribild (elvitegravir/cobicistat/emtricitabine/tenofovir DF) is safe, tolerable and acceptable when taken for 28 days, once a day after a possible, sexual, exposure to the Human Immune Deficiency Virus (HIV).

NCT ID: NCT01825031 Completed - Clinical trials for Human Immunodeficiency Virus

Reduction of EArly mortaLITY in HIV-infected Adults and Children Starting Antiretroviral Therapy

REALITY
Start date: June 2013
Phase: Phase 3
Study type: Interventional

A randomised controlled trial to investigate three methods to reduce early mortality in adults, adolescents and children aged 5 years or older starting antiretroviral therapy (ART) with severe immuno-deficiency. The three methods are: (i) increasing the potency of ART with a 12 week induction period using 4 antiretroviral drugs from 3 classes (ii) augmented prophylaxis against opportunistic/bacterial infections and helminths for 12 weeks (iii) macronutrient intervention using ready-to-use supplementary food for 12 weeks.

NCT ID: NCT01812980 Completed - Influenza Clinical Trials

Immunogenicity and Safety of Trivalent Influenza Vaccine in Non-pregnant HIV-infected Women

Start date: May 2013
Phase: Phase 4
Study type: Interventional

The overall aim of this project is to evaluate the immunogenicity of TIV vaccination in HIV-infected non-pregnant women in 2013. Safety data including solicited local and systemic reactions to the vaccine will also be assessed.

NCT ID: NCT01792570 Completed - Clinical trials for Human Immunodeficiency Virus

DRV/r + RPV QD: Efficacy and Toxicity Reduction

Start date: September 30, 2014
Phase: Phase 3
Study type: Interventional

Clinical approach to HIV infection treatment is based on the use of highly active antiretroviral therapies (HAART) and recent national and international guidelines for guiding HIV therapy recommend the use of triple-combination therapy using antiretrovirals with 2 nucleos(t)ide inhibitors [N(n)RTI] as backbone plus a third drug to be chosen among a boosted protease inhibitor (PI/r), a nonnucleoside inhibitor (NNRTI) or an integrase inhibitor (II). In spite of evident efficacy of HAART, as demonstrated by survival increasing, long term side effects, as for example the impact on renal function, remain principal problem. In patient with risk factor for renal disease, a reduction of eGRF (estimated Glomerular Filtration Rate) between 90 and 60 mL/min/1,73 m2 could be already considered as a risk condition [1,2]. Efficacy of HAART, with increase of media survival and the parallel decrease of mortality, has underlined the necessity to reflect on long term HAART effects [3]. There are many evidences of HAART-related toxicity that, in spite of the necessity of a life-saving therapy, focus on the additional costs of this situation, in terms of health as well as in terms of economic costs. Particular attention has been focused on the impact of some drugs on renal function, as tenofovir, especially on tubule, without forgetting the modification of lipid and bone metabolisms. According to further studies which have evidenced the potential of some recently introduced molecules [4,5], the investigators had the need to realize a study to deepen the feasibility of a dual-therapy that permit to exclude NRTIs from the backbone, with the aim to prevent NRTIs-related long-term toxicity. The investigators have designed a prospective randomized controlled trial, open-label, with a duration of 96 weeks, to compare the efficacy of a dual-therapy based on rilpivirine 25mg plus darunavir 800mg/ritonavir 100mg QD, in HIV-positive subjects with suppressed viremia from at least 3 months. In fact, there are a few data about association of these drugs, which it has been shown to be safe, well tolerated, and with a strong pharmacological synergy, without nucleos(t)idic backbone, while the necessity to minimize the costs toxicity-related is becoming increasingly compelling. According to clinical experience and literature data, the investigators hope this study shows positive results in term of immune-virological efficacy, as well as in term of decrease of VACS index - a complex parameter which has the purpose to quantify general organic decay - and markers of lipid and bone metabolism, in group which receives dual-therapy versus the group with standard therapy.

NCT ID: NCT01786148 Completed - Clinical trials for Human Immunodeficiency Virus

Music for Health Project

MFH
Start date: June 2014
Phase: N/A
Study type: Interventional

The overall goal of this project is to use technology to improve adherence to antiretroviral therapy (ART)and increase access to ART adherence care for those HIV+ persons living in rural areas. The LIVE Network audio music program mobile application (app) is innovative, practical, portable, and could be rapidly scaled up to address the adherence self-management needs of rural groups nationwide. If successful, the impact on HIV care will be immense and could transform the delivery of HIV self-management and adherence education by overcoming barriers of geographic isolation, transportation, stigma and confidentiality in this vulnerable group.

NCT ID: NCT01783678 Completed - Chronic Hepatitis C Clinical Trials

A Phase 3, Open-label Study to Investigate the Efficacy and Safety of Sofosbuvir Plus Ribavirin in Chronic Genotype 1, 2, 3 and 4 Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV) Co-infected Adults

Start date: January 2013
Phase: Phase 3
Study type: Interventional

This is an Open-label Phase 3 study in adults with chronic genotypes 1, 2, 3, and 4 HCV infection who are co-infected with HIV-1.

NCT ID: NCT01755754 Completed - Clinical trials for Human Immunodeficiency Virus

A Trial to Assess the Functionality of Female Condom With a Silicone Elastomer Vaginal Ring

Start date: August 2013
Phase: Phase 1
Study type: Interventional

A multi-center, open-label, randomized, two-period, crossover non-inferiority trial to assess the functionality of female condoms with a silicone elastomer vaginal ring.

NCT ID: NCT01755741 Completed - Clinical trials for Human Immunodeficiency Virus

Functionality of Male Condoms With a Silicone Elastomer Vaginal RIng

Start date: February 2013
Phase: Phase 1
Study type: Interventional

This trial will assess the potential impact of a vaginal ring on condom use by comparing the performance (total clinical failure, clinical slippage, and clinical breakage) of a standard male lubricated latex condom when the female partner is wearing the vaginal ring and when the female partner is not wearing the vaginal ring.

NCT ID: NCT01734850 Completed - Clinical trials for Human Immunodeficiency Virus

Safety Study of a Dual Anti-HIV Gene Transfer Construct to Treat HIV-1 Infection

Start date: April 2013
Phase: Phase 1/Phase 2
Study type: Interventional

This is an early phase research study looking at whether an experimental gene transfer, LVsh5/C46 (also known as Cal-1), is safe and if it can protect the immune system from the effects of HIV without the use of antiretroviral drugs. Cal-1 is an experimental gene transfer agent designed to inhibit HIV infection through 2 active parts: 1. Removing a protein named CCR5 from bone marrow and white blood cells 2. Producing a protein named C46 on bone marrow and white blood cells

NCT ID: NCT01721226 Completed - Clinical trials for Human Immunodeficiency Virus

CARE Corrections: Technology for Jail HIV/HCV Testing, Linkage, and Care (TLC)

CARE+
Start date: August 2013
Phase: N/A
Study type: Interventional

The purpose of this study is to determine whether an intervention (CARE+ Corrections) delivered to HIV-infected detainees within the DC Department of Corrections (DOC) and recently -released ex-detainees in the community can improve linkage to community HIV care and adherence to HIV medications after release, and ultimately achieve or maintain HIV viral suppression following community re-entry.