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HIV clinical trials

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NCT ID: NCT02272946 Completed - HIV Clinical Trials

Effect of IL--1β Inhibition on Inflammation and Cardiovascular Risk

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

The purpose of this study is to evaluate the effects of IL-1β inhibition on safety, measures of systemic and vascular inflammation and endothelial function (all indicators of cardiovascular risk) in treated and suppressed HIV infected individuals This study will assess the safety and effects of canakinumab on endothelial function (assessed by flow-mediated vasodilation [FMD] of the brachial artery), vascular inflammation (assessed by FDG-PET/CT scanning), key inflammatory markers of cardiovascular disease (CVD) risk (high-sensitivity C-reactive protein [hsCRP]), interleukin-6 (IL-6), soluble CD163 (sCD163), D-dimer, T-cell and monocyte activation in the blood, and size of the HIV reservoir. 10 individuals will receive a single dose of 150mg canakinumab with follow-up for 12 weeks. In the second part of the study, 100 participants will be randomized (2:1 - canakinumab to placebo) and will be followed by for 36 weeks.

NCT ID: NCT02272829 Completed - HIV Clinical Trials

Behavioral Consultation for HIV+ Older Adults Prescribed Opioids for Chronic Pain

CHOACOT
Start date: May 2015
Phase: N/A
Study type: Interventional

This project will develop a novel collaborative treatment, based on the primary care behavioral consultation model and behavior therapy techniques including motivational interviewing and functional assessment, in which a patient, a Behavioral Health Consultant (BHC) and a HIV primary care provider share a unified plan targeting misuse of prescribed opioid analgesics in older HIV+ adults. The intervention will involve meetings between the BHC and the PCP, the BHC and the participant, and the BHC, PCP and the participant. Opioid misuse will be the primary outcome variable. Quality of the patient-provider relationship, pain, problematic use of other substances, antiretroviral adherence, and psychosocial functioning will be secondary outcomes.

NCT ID: NCT02271074 Completed - HIV Clinical Trials

Thol'Impilo: Bringing People Into Care

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

The main objective of this study is to compare the effectiveness of combinations of three patient-oriented strategies, compared to the standard of care, to increase the proportion of patients who enter-into-care for HIV within 90 days of testing HIV positive.

NCT ID: NCT02269462 Completed - HIV Clinical Trials

A Study to Evaluate the Effects of Genetic Factors on the Pharmacokinetics of Antiretroviral Drugs During Pregnancy and Lactation

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

Mother-to-child transmission of HIV (MTCT) during pregnancy and breastfeeding is prevented with maternal antiretroviral drugs (ARV) and infant nevirapine post-exposure prophylaxis (PEP). However, the pharmacokinetics of certain ARVs is associated with marked inter-individual variability. This variability has been associated with single nucleotide polymorphisms (SNPs) in genes encoding metabolising enzymes, transporters and transcriptional regulators. Pregnancy is also associated with additional changes in pharmacokinetics. The resulting sub-therapeutic or supra-therapeutic drug exposures may have serious consequences for virological control, MTCT, emergence of drug resistance, and toxicity. Foetal and infant exposure to maternal ARV during pregnancy and breastfeeding is believed to play a role in the prevention of mother-to-child transmission of HIV (PMTCT). However, such exposures may also result in toxicity. For example, efavirenz is contraindicated in children less than 3 years old or 10kg but transferred to breastfed babies through breast milk. On the other hand, double exposure to nevirapine from breast milk and PEP may also predispose breastfed infants to nevirapine-associated toxicity. In the proposed study, the influence of selected SNPs in certain drug disposition genes on the pharmacokinetics of efavirenz and nevirapine during pregnancy and lactation, as well as the level of infant exposure to both drugs through breast milk, will be studied. Mathematical models will be developed to predict potential dose optimisation strategies during pregnancy, and to predict infant exposure to maternal drugs through breast milk.

NCT ID: NCT02264509 Completed - HIV Clinical Trials

Peripheral Arterial Insufficiency Associated With HIV/AIDS

AIHIV
Start date: September 2014
Phase: N/A
Study type: Observational [Patient Registry]

The purpose of this study is to determine the risk factors associated with the occurrence of arterial insufficiency in patients with HIV / AIDS, and to identify the prevalence of this disease. The estimated prevalence is 10%, similar to that reported in the general population.

NCT ID: NCT02263391 Completed - HIV Clinical Trials

HIV Risk and Prevention in Women

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

This study gathers information about HIV testing utilization and influences on HIV testing decisions among young, general population Russian women at-risk of HIV exposure. The study compares HIV testing acceptance across two types of low-barrier testing strategies (opt-in vs. opt-out) and conducts one of the first randomized experimental comparisons of these strategies. The overarching goal is to gain knowledge that can be used to increase utilization of HIV testing among at-risk young women and offer gender-specific strategies for improving prevention.

NCT ID: NCT02259101 Completed - HIV Clinical Trials

RCT of CBT for Insomnia With PLWHA

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

The proposed study will consist of a randomized controlled trial (RCT) comparing a known efficacious treatment for insomnia (CBT-I) to a sleep hygiene (SH) comparison condition.

NCT ID: NCT02258685 Completed - HIV Clinical Trials

Factors Mediating Gut Microbiota Dysbiosis and Metabolic Disease in HIV Patients.

Start date: November 2014
Phase:
Study type: Observational

This study plans to learn more about immune responses in intestinal (gut) tissue in people with human immunodeficiency virus (HIV) infection. This study will determine whether change in the composition of gut bacteria in HIV infected individuals is related to a high prevalence of chronic gut inflammation and metabolic disease. The investigators will also investigate immune-modulatory properties of specific bacteria that correlate with disease both by characterizing which functional genes are selected for in their genomes and by stimulating immune cells isolated from blood and gut tissue with bacterial isolates. This work will establish whether gain/loss of bacterial drivers/suppressors of information in the gut contributes to metabolic disease in HIV-infected individuals.

NCT ID: NCT02256592 Completed - HIV Clinical Trials

Fecal Microbiota Transplantation in HIV

FMT-HIV
Start date: October 2014
Phase: Phase 1
Study type: Interventional

Even in individuals treated for HIV, chronic immune activation persists and is associated with increased cardiovascular disease, liver disease, and mortality. HIV-infected individuals have imbalances in the community of intestinal microbes which is thought to contribute to increased and persistent inflammation. The purpose of this study is to examine the safety and durability of fecal microbiota transplant (FMT), the transfer of the bacterial community in stool from a healthy donor, in HIV+ individuals on anti-retroviral therapy. The study will also measure the effects of FMT on immune activation and inflammatory biomarkers in anti-retroviral treated HIV+ individuals.

NCT ID: NCT02252471 Completed - HIV Clinical Trials

Choices-Teen: A Bundled Risk Reduction Intervention for Juvenile Justice Females

Start date: July 2012
Phase: N/A
Study type: Interventional

This pilot study will: 1) demonstrate the feasibility of delivering CHOICES-TEEN with master's level mental health professionals within a juvenile justice setting; 2) determine acceptance of CHOICES-TEEN as measured by client adherence, retention, and treatment satisfaction; and 3) assess client improvement at 3-month follow-up (e.g., reduction of risk of HIV, nicotine-exposed pregnancy, and alcohol-exposed pregnancy).