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Human Immunodeficiency Virus clinical trials

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NCT ID: NCT03922269 Not yet recruiting - HIV Infections Clinical Trials

Trans People Living With HIV Throughout Europe

Start date: July 1, 2019
Study type: Observational

The project will study a European cohort of individuals identifying themselves as transgender or non-binary and living with HIV. The study will collect both qualitative data on this cohort and clinical data over an 18 month period. The study will investigate the success of HIV treatment for this cohort through the primary outcome measure of HIV viral load recorded in routine blood tests. The results from this study will assist in informing future HIV treatment guidelines on the monitoring of HIV infection in transgender and non-binary individuals and assisting in the design of future interventional studies within this population.

NCT ID: NCT03912753 Recruiting - Clinical trials for Human Immunodeficiency Virus

Building Mobile HIV Prevention and Mental Health Support in Low-resource Settings

Start date: May 2019
Phase: N/A
Study type: Interventional

This project is designed to remedy unaddressed and interlocking HIV-prevention and mental health needs among gay and bisexual men (GBM) in the Central Eastern European country of Romania, and their underpinning stigma-related mechanisms. Rampant stigma contributes to the increasing prevalence of HIV among Romanian GBM (from under 10% in 2009 to close to 20% in 2014, by best available estimates) and keeps GBM out-of-reach of HIV-prevention services. An mHealth pilot intervention (titled "Despre Mine. Despre Noi." [DMDN] translated as "About Me. About Us."), which reduced Romanian GBM's risk for HIV infection while also reducing depression and alcohol abuse in an initial pre-post trial, is now ready for testing in a randomized controlled trial with a large national sample in the current study, entitled Comunică (translation: Communicate). The Comunică intervention entails eight 60-minute live chat sessions delivered by trained counselors on a mobile study platform using motivational interviewing (MI) and cognitive-behavioral skills training (CBST). First, during pre-trial (mos 1-5), in collaboration with a community advisory board consisting of GBM community members, GBM-affirmative physical and mental health providers, and a technical developer, the investigators will fine-tune the Comunică intervention based on the investigators' pilot findings and evaluation interviews, and expand the original DMDN education materials for an education attention condition (EAC) that will serve as control. Second, during the intervention phase (mos 6-45), the investigators will recruit, screen, assess, and randomize GBM at risk for HIV infection and alcohol abuse to either the Comunică intervention (n=163) or EAC (n=163). The conditions are content matched, and both are hosted on the study platform. While Comunică will consist of eight weekly mHealth live chat sessions, EAC will consist of eight self-administered educational modules. Third, during the follow-up phase (mos 8-55), the investigators will assess at 4, 8, and 12 months post-baseline, in a mobile fashion identical to the baseline, the primary outcome of condomless anal sex with male partners and secondary outcomes of alcohol abuse, depression, biologic HIV/STI infection, HIV/STI testing, and psychosocial mechanisms rooted in the Information-Motivation-Behavioral Skills (IMB) model (e.g., HIV/STI knowledge, condom use self-efficacy) and minority stress theory (e.g., identity concealment, internalized homophobia).

NCT ID: NCT03904186 Not yet recruiting - Depression Clinical Trials

Effectiveness of an Integrated Treatment to Address Smoking Cessation and Anxiety/ Depression in People Living With HIV

Start date: August 1, 2019
Phase: Phase 3
Study type: Interventional

Smokers living with HIV represent a major health disparity population in the United States and the world more generally. Major contributing factors to the maintenance and relapse of smoking among smokers living with HIV include increased exposure to multiple stressors associated with HIV, which often exacerbates anxiety/depression. In a previous project, the feasibility, acceptability, and initial efficacy of a 9-session, cognitive-behavioral-based intervention to address smoking cessation by reducing anxiety and depression via specific emotional vulnerabilities (anxiety sensitivity, distress tolerance, and anhedonia) was tested against an enhanced standard of care in a pilot randomized controlled trial (NCT01393301). It was found that when compared to a brief enhanced treatment as usual control, patients in the intervention achieved higher short-term and long-term smoking abstinence rates. In this project we seek to test this same intervention in a fully powered, 3-arm efficacy/effectiveness trial. Our goal is to randomize 180 smokers across three sites to test the efficacy/effectiveness of the intervention at increasing point prevalence abstinence by reducing anxiety and depression at a 1-month follow-up (the end of treatment timepoint/ approximately 1-month post quit day) and a 6-month follow-up (approximately 6-months post quit day).

NCT ID: NCT03898557 Not yet recruiting - Clinical trials for Human Immunodeficiency Virus

Plan and Pledge, HIV Self-testing in South Africa

Start date: June 1, 2019
Phase: N/A
Study type: Interventional

The Plan and Pledge pilot will incorporate behavioral economics approaches (nudges) into the pre-existing STAR self-test fixed-site distribution program, implemented by Wits Reproductive Health and HIV Institute (Wits RHI) at the University of Witwatersrand, Johannesburg, South Africa. The objective of this pilot is to examine the use of commitment strategies to increase uptake of HIV self-testing in South Africa.

NCT ID: NCT03894124 Not yet recruiting - Clinical trials for Human Immunodeficiency Virus

Pharmacokinetics of Plasma Doravirine Once Daily Over 72 Hours Following Drug Intake Cessation in Healthy Volunteers

Start date: June 2019
Phase: Phase 1
Study type: Interventional

Study to assess the pharmacokinetics of plasma doravirine once daily over 72 hours following drug intake cessation at steady-state in healthy volunteers

NCT ID: NCT03886701 Recruiting - Clinical trials for Human Immunodeficiency Virus

Doravirine, Rifapentine and Isoniazid Interaction

Start date: April 2019
Phase: Phase 1
Study type: Interventional

Drug therapy for persons living with human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS) co-infected with latent tuberculosis infection (LTBI) is complex. Anti-tuberculosis drugs used to treat LTBI often induce drug metabolizing enzymes that share the same metabolic pathway as antiretroviral drugs used for those living with HIV/AIDS. This study evaluates the drug-drug interaction (DDI) potential of an antiretroviral drug when co-administered with a common anti-tuberculosis regimen of drugs.

NCT ID: NCT03855176 Recruiting - Clinical trials for Human Immunodeficiency Virus

Effectiveness of Booster With 1 or 2 Doses of HAV Vaccine Among HIV-infected Patients

Start date: September 12, 2017
Phase: Phase 4
Study type: Interventional

Though HAV is mainly transmitted through the fecal-oral route, infection by sexual intercourse and blood transfusion is also possible. Injection drug users (IDUs) and men who have sex with men (MSM) have a higher risk of acquiring HAV due to their behaviors. Reemerging threat of hepatitis A among MSM in Taiwan has been reported recently. Based on the guidelines for the diagnosis and treatment of HIV/AIDS and the Advisory Committee on Immunization Practices (ACIP), Taiwan, vaccination of individuals against HAV with any of the following indications is recommended: HIV patients, adults with chronic hepatic disease, hemophilia, liver transplantation, occupational exposure, MSM, persons who use injection or noninjection illicit drugs, or persons traveling to or working in countries that have endemicity of HAV. In HIV-infected patients, the immunogenicity to HAV vaccination is sub-optimal in HIV-infected patients and the seroconversion rate is estimated 68-90% after administration of 2 or 3 doses of HAV vaccine. Furthermore, the antibody titers of HIV-infected patients following HAV vaccination are significantly lower compared to those of HIV-uninfected persons. The sub-optimal response among HIV-infected subjects remains an unresolved problem. In this study, the investigators aim to determine the to conduct a randomized clinical trial to compare the immunogenicity of 2 different doses of HAV vaccination (1 dose versus 2 doses) in HIV-infected patients who failed to achieve serologic response in the primary vaccination. This proposal will provide the solid evidence to elucidate the role of booster HAV vaccination in HIV-infected patients without response to primary HAV vaccination.

NCT ID: NCT03839212 Not yet recruiting - Clinical trials for Human Immunodeficiency Virus

The Happy Older Latinos Are Active (HOLA) Health Promotion Study in HIV-Infected Latino Men

Start date: December 1, 2019
Phase: N/A
Study type: Interventional

The purpose of this study is to examine the feasibility of an intervention to prevent chronic diseases like diabetes, high blood pressure, and obesity in midlife and older Latino adults living with HIV. The investigators expect that the participant will be in this study for seven months. Participants will be interviewed and asked to take part in walking groups.

NCT ID: NCT03826160 Recruiting - Clinical trials for Human Immunodeficiency Virus

Growth Hormone Dynamics and Cardiac Steatosis in HIV

Start date: January 30, 2019
Study type: Observational

Cardiac steatosis is increased among individuals with HIV, and may predispose to cardiac mechanical dysfunction and subsequent heart failure. The pathogenesis and treatment of cardiac steatosis is not well understood. The investigators have previously shown that perturbed growth hormone (GH) secretion in HIV contributes to ectopic fat accumulation in the viscera and the liver. Moreover, the investigators have found that augmentation of endogenous GH secretion with the FDA-approved medication tesamorelin reduces visceral and hepatic fat. In this longitudinal observational study, the investigators will examine patients with HIV and abdominal fat accumulation who either plan or do not plan to initiate tesamorelin prescribed clinically. The investigators hypothesize that blunted GH secretion in HIV is associated with cardiac steatosis. The investigators also hypothesize that use of tesamorelin for 6 months is associated with a reduction in intramyocardial fat and preserved cardiac function.

NCT ID: NCT03823209 Enrolling by invitation - Clinical trials for Human Immunodeficiency Virus

Increasing PrEP Use in High-Risk Social Networks of African-American MSM in Underserved Low-Risk Cities

Start date: January 24, 2019
Phase: N/A
Study type: Interventional

This study evaluates the use of a social-network approach to encourage African-American men who have sex with men (AAMSM) to adopt pre-exposure prophylaxis (PrEP) to prevent HIV infection. Thirty-six networks of AAMSM will be recruited in Milwaukee, WI, and Cleveland, OH. Half of these networks will have their leaders trained to endorse PrEP to their social network members, and the other half will be given brief HIV prevention counseling.