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NCT ID: NCT02442700 Completed - HIV Clinical Trials

Effects of Pitavastatin on Lipid Profiles in HIV-infected Patients With Dyslipidemia and Receiving Atazanavir/Ritonavir

Start date: May 2014
Phase: Phase 4
Study type: Interventional

Dyslipidemia as a risk factor for cardiovascular disease (CVD) is an increasing problem in HIV-infected patients who are on antiretroviral therapy especially protease inhibitors including atazanavir. Pitavastatin is a new HMG-CoA reductase inhibitor with lesser drug-drug interactions and demonstrable efficacy in decreasing lipid levels in non HIV-infected individuals. The study was conducted as a randomized, double-blind, crossover study comparing the safety and efficacy of pitavastatin versus placebo in HIV-infected patients with dyslipidemia and receiving atazanavir/ritonavir. Patients were randomized to receive either placebo or pitavastatin for 12 weeks, underwent a 2-week washout period, and then were given the other treatment for an additional 12 weeks. Patients were observed for lipid profiles including total cholesterol (TC), triglyceride (TG), low density lipoprotein (LDL) and high density lipoprotein (HDL); and the side effects including clinical and laboratory (serum aspartate aminotransferase (AST), alanine aminotransferase (ALT) and creatinine phosphokinase (CPK)). The follow-up visits were every 4 weeks until the end of the study.

NCT ID: NCT02440256 Completed - HIV Clinical Trials

Expanded HIV Care in Opioid Substitution Treatment (EHOST) Trial

EHOST
Start date: September 2015
Phase: N/A
Study type: Interventional

Opioid Substitution Treatment (OST) provides a critical opportunity for HIV testing and linkage to antiretroviral treatment. The EHOST study will evaluate a prescriber-focused intervention to increase HIV testing rates, and optimize antiretroviral treatment, re-engagement and retention outcomes among individuals engaged in OST. 46 OST sites in British Columbia will be randomly allocated into three clusters. Clusters will initiative the intervention at different time points, or steps, with every cluster receiving the intervention.

NCT ID: NCT02439918 Completed - HIV Clinical Trials

Epidemic History and Iatrogenic Transmission of Blood-borne Viruses in Mid-20th Century Kinshasa

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

Kinshasa, Democratic Republic of Congo (DRC), is where human immunodeficiency virus type 1 (HIV-1) appears to have most diversified. The factors that lead to jumpstarting the HIV-1 epidemic remain unclear; mounting evidence suggests medical interventions may have contributed. Hepatitis C virus (HCV) and human T-cell lymphotropic virus type 1 (HTLV-1) are viruses compatible with long-term survival but with broadly similar modes of transmission as HIV. The main objective was to assess the association of past intravenous treatment with HCV and HTLV-1 seropositivity. The investigators hypothesized that medical interventions in the mid-20th century may have facilitated the emergence of HIV-1 in central Africa. To assess the association of injectable treatments with HCV and HTLV-1 infection and to reconstruct past virus dynamics, the investigators conducted a cross-sectional study of 839 elderly long-term inhabitants of Kinshasa, with serological assays followed by amplification and sequencing. Risk factors were assessed through logistic regression. Phylogenetic methods were used to reconstruct the epidemic history of HCV.

NCT ID: NCT02438930 Completed - HIV Clinical Trials

Client-Centered Counseling During Routine/Opt-Out HIV-Testing in Uganda

Start date: May 2008
Phase: N/A
Study type: Interventional

This study pilot tests and intervention to help individuals reduce their risk for acquiring or transmitting HIV. The intervention is implemented when people are tested for HIV in an outpatient clinic in rural Uganda. Approximately half of participants will receive the intervention and the other half will receive the usual counseling provided during HIV counseling and testing.

NCT ID: NCT02438592 Completed - HIV Clinical Trials

PHASES: Provision of HIV Treatment at ATN Sites: An Evaluation for Stakeholders

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

This is an observational study involving retrospective and prospective medical record review covering a total maximum of 104 weeks (24 months) per subject. An Audio Computer- Assisted Self-Interview (ACASI) at study entry will assess demographic and psychosocial variables of study subjects. Data will also be collected to assess clinic level variables. Definitions of engagement, prescription of antiretroviral therapy (ART), and viral suppression in the Continuum of Care (CoC) will utilize common definitions including those by U.S. Department of Health and Human Services (DHHS) and Health Resources and Services Administration (HRSA) HIV/AIDS Bureau (HAB). Data will be collected in a large, simple trial design manner to provide all elements for both the primary and secondary outcomes.

NCT ID: NCT02437123 Completed - HIV Clinical Trials

The Cedar Project: Impact of mHealth for HIV Prevention Among Young Indigenous People Who Use Illicit Drugs

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

This study will examine the effect of a culturally-safe two-way supportive text message intervention to reduce HIV vulnerability among young Indigenous people who use illicit drugs in a community-based setting. The study is nested within The Cedar Project, an ongoing cohort study addressing HIV and Hepatitis C vulnerability among young Indigenous people who use drugs in Vancouver and Prince George, British Columbia, Canada. Indigenous collaborators and investigators, collectively known as the Cedar Project Partnership, govern the entire research process. A stratified Zelen pre-randomized design will be used to identify a random selection of cohort members to be offered the Cedar Project mHealth intervention with consent. Participants in the intervention arm will receive a package of supports, including a mobile phone and long-distance plan, weekly two-way supportive text messaging via the WelTel platform, and support from Cedar Advocates. Those drawn from the cohort study population as the comparison group will continue on in the usual Cedar Project study under its existing informed consent with no change whatsoever to their participation in the overall study. The main outcome is an HIV propensity score, assessed at six months and one year. Secondary outcomes include HIV risk, resilience, access to drug-related services, psychological distress, and connection to culture measured at six months and one year. Primary analysis is by intention to treat.

NCT ID: NCT02434848 Completed - HIV Clinical Trials

A Pilot Study Comparing the Immunogenicity of Fendrix vs. Double-dose Engerix B in HIV-infected Non-responders to Standard Hepatitis B Vaccination Courses

Start date: July 23, 2015
Phase: Phase 2/Phase 3
Study type: Interventional

Hepatitis B virus (HBV) infection can result in a greater risk of adverse outcomes in HIV-infected individuals, including more rapid progression to cirrhosis and associated complications such as hepatocellular carcinoma. For this reason, as well as the shared routes of transmission between the two viruses, UK and International guidance recommends that all HBV-negative HIV-infected individuals be offered vaccination against HBV. Unfortunately, response rates in this population can be as low as 17.5 - 40% to standard vaccination courses. To improve this response, strategies such as the use of double dose of standard vaccines (e.g. Engerix B) is recommended in several guidelines for previous non-responders, although there is currently limited evidence for this approach. An alternative strategy is to use vaccines with novel adjuvants such as Fendrix and observational clinical data in the Investigators HIV cohort suggests that response rates can be as high as 81% of individuals achieving HBV surface antibody (HBsAb) levels >100 in a group that did not respond to previous standard HBV vaccine courses. However, the cost of Fendrix is considerably higher than Engerix B and controlled trials are required to confirm whether this approach is warranted. Furthermore, insights into the potential mechanisms by which Fendrix may elicit better responses would be valuable in optimising future vaccine strategies in this population. The Investigators propose to conduct a randomised, open label, active-controlled pilot study comparing double dose Engerix B and Fendrix in HIV-infected non-responders to standard HBV vaccine courses, which will provide the necessary data to design and power a larger multicentre randomised controlled trial. Outcome measures will include the proportion of individuals seroconverting with HBsAb levels >100 following each vaccination course, the magnitude and quality of the HBV-specific CD4+ T-cell responses elicited by each vaccine and the durability of the HBsAb response at 1 year following the end of vaccination.

NCT ID: NCT02431975 Completed - HIV Clinical Trials

Latency and Early Neonatal Provision of Antiretroviral Drugs Clinical Trial

LEOPARD
Start date: August 2015
Phase: Phase 4
Study type: Interventional

The investigators propose a non-randomized clinical trial of 60 HIV-infected infants identified within 48 hours of birth and their mothers to investigate the consequences of very early ART on the establishment and maintenance of the viral reservoir. The first phase (early ART initiation within 48 hours of birth) will examine the trajectory i.e. changes over time of the viral reservoir and detection of HIV-specific antibody responses in infants testing HIV-positive within 48 hours of birth and initiating early ART. Secondary pathogenesis aims will test whether markers of neonatal immune quiescence are associated with the extent of seeding and rate of decline of the viral reservoir when ART is started at a young age and investigate whether markers in infant stool samples can be used as a non-invasive method of defining relevant immune and HIV-specific parameters associated with viral reservoir size. The investigators hypothesize that developmental characteristics of newborn immunity may make this period the optimal time to begin ART and influence the seeding of the viral reservoir.

NCT ID: NCT02431325 Completed - HIV Clinical Trials

A Study of the Gut Barrier and Blood Vessel Inflammation in Individuals With and Without HIV

Start date: December 2015
Phase: Phase 2
Study type: Interventional

The purpose of this research study is to determine whether teduglutide can repair a "leaky" gut, decrease inflammation, and prevent or treat plaque, a build-up of fat and other materials in the blood vessels of the heart, in people with HIV. HIV disease is linked to inflammatory changes and leakiness of the gut. These changes or conditions may increase the risk of developing heart and blood vessel disease. The investigators believe teduglutide can help repair the gut barrier in people with HIV, leading to a decrease in inflammation and plaque in the blood vessels of the heart.

NCT ID: NCT02429869 Completed - HIV Clinical Trials

Impact of Everolimus on HIV Persistence Post Kidney or Liver Transplant

HIVTR-EVE
Start date: February 24, 2016
Phase: Phase 4
Study type: Interventional

Zortress (everolimus), the 40-O-(2-hydroxyethyl)-derivative of rapamycin, is an mTOR inhibitor approved for rejection prophylaxis in kidney transplant recipients. mTOR inhibition may favorably impact the HIV viral reservoir, and we hypothesize that adding everolimus to the transplant immunosuppressive regimen of HIV positive transplant recipients will decrease HIV persistence in CD4+ lymphocytes.