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HIV Infections clinical trials

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NCT ID: NCT01348516 Completed - Clinical trials for Human Immunodeficiency Virus

Single Ascending Dose (SAD)/Multiple Ascending Dose(MAD) Safety/Pharmacokinetic (PK) Study of KM-023

Start date: May 2011
Phase: Phase 1
Study type: Interventional

The purpose of this study is to investigate the safety and pharmacokinetics of KM-023 after single/multiple dosing.

NCT ID: NCT01348282 Completed - HIV Infection Clinical Trials

Efficacy and Safety of Two Pharmacologic Strategies on Neurocognitive Impairment in HIV Infection. The TRIANT-TE Study

Start date: May 2011
Phase: Phase 4
Study type: Interventional

The current project proposes the comparison of two pharmacologic strategies as adjunctive treatments for the improvement of HIV-associated neurocognitive disruption, additionally to use of HAART. The investigators propose the use of the compound that has shown greatest benefits in this context to date, the lithium, versus the use of a well-tolerated and promising drug in other pathologies with neurocognitive affectation, such as Alzheimer or Parkinson diseases, which is the rivastigmine. In those other diseases, this second compound has recently offered a good tolerability, but also benefits on attention, memory and other neurocognitive areas. Both study groups, patients on therapy with lithium and patients on therapy with rivastigmine, will be compared to a control group, which will not initiate any other treatment (therefore only continuing antiretroviral therapy). The investigators are aware that this proposal will offer new relevant data for the study of neurocognitive improvement in HIV infection, as well will allow a better knowledge of clinical management of HIV-infected patients with CNS disease, an aspect that is a common clinical concern today.

NCT ID: NCT01347437 Completed - HIV Infection Clinical Trials

Improving Antiretroviral Medication Adherence Among HIV-infected Youth

Start date: July 2011
Phase: N/A
Study type: Interventional

HIV is increasing among adolescents and young adults in the US. Antiretroviral medications, when taken correctly (≥ 90% of prescribed doses taken), can vastly improve life expectancy. However, adherence among HIV-infected young people is suboptimal, and few interventions are available to help adolescents adhere to treatment. The study is a randomized controlled trial (RCT) pilot trial of Positive STEPS (the adapted form of the Life-Steps behavioral intervention) to improve medication adherence among HIV-infected youth. The study will allow us to demonstrate participant acceptance, ability to recruit, feasibility of intervention delivery with study counselors and all study procedures, and initial clinically significant improvement in medication adherence via MEMS caps. This research will lay the groundwork for a federal grant application for a multi-site randomized controlled intervention trial.

NCT ID: NCT01344642 Completed - HIV Infections Clinical Trials

Qualitative and Quantitative HIV RNA Detection in Saliva Using the Oragene RNA Kit

Start date: October 2007
Phase: N/A
Study type: Observational

The purpose of this study is to determine if the Oragene.RNA kit is able to detect HIV RNA in saliva.

NCT ID: NCT01344148 Recruiting - AIDS Clinical Trials

Acquired Immunodeficiency Syndrome(AIDS) and Tuberculosis(Tb) Co-infection Treatment Strategies Study of China.

Start date: February 2009
Phase: N/A
Study type: Interventional

To determine the best time to begin anti-HIV(Acquired Immunodeficiency Syndrome) treatment in individuals who co-infected with HIV and tuberculosis (Tb). This prospective, randomized study is being conducted on HIV/Tb co-infected patients in China to evaluate and compare the efficacy of antiretroviral therapy after 2 weeks TB treatment versus deferred ART initiated 8 weeks after initiation of TB treatment.

NCT ID: NCT01343654 Completed - HIV Infections Clinical Trials

Text Messaging Intervention to Improve HIV Adherence in Rural Drug Users

TEXTR34
Start date: May 2011
Phase: N/A
Study type: Interventional

The investigators will develop and test the feasibility and promise of a combined HIV adherence assessment and intervention application for rural drug users using an available, familiar technology whose reach will grow exponentially: text messaging via mobile phones. By 2007, 84% of U.S. residents had mobile phones, with near 100% mobile phone penetration projected by 2013. While technology adoption is often slower in under-served communities, the trend is different with mobile phone technology. African-Americans are using more mobile phone minutes per capita and increasing their use at a higher rate compared with other ethnic groups. This technology has great potential to reduce health disparities. In this project, the investigators will develop and test the feasibility and promise of a text messaging application and system using Ecological Momentary Assessment methods to detect nonadherence and drug use and immediately intervene to improve HIV treatment adherence in drug users living with HIV/AIDS who reside outside major metropolitan areas. This R34 is a Stage 1b/2a project in the Stage Model of Behavioral Therapy Development that will develop novel interventions and methods, and generate preliminary estimates of effect sizes that will determine whether a larger clinical trial with extended follow-up and cost-effectiveness evaluation is warranted. The specific aims of this project are: 1. To identify assessment and intervention features relevant to the adherence barriers and drug use patterns of rural and non-urban HIV+ drug users using formative methods including: - structured interviews and focus groups to identify specific barriers to adherence and engagement in care and needs related to drug craving and drug use that should be addressed by the intervention - iterative usability testing of components and drafts of the intervention 2. To create a text messaging mobile phone application and system (Treatment Extension by Texting, Text) to assess and improve HIV treatment adherence and drug use in real time --Text will be built upon a piloted unidirectional personalized text phone application and system, STeM, and will include pre- and post-programming usability testing 3. To test the feasibility and promise of the assessment and intervention tool in a randomized pilot trial of rural HIV+ drug users with detectable viral load (VL) comparing Text to usual care - Feasibility: Identify recruitment rates, consent rates, participant flow, completion rates, and variance of key covariates and outcome variables - Promise: determine point estimates and the precision of effects for primary and secondary adherence outcomes including pharmacy refills and unannounced pill counts (medication adherence), missed visit percentage (treatment engagement), VL, and drug craving and drug use.

NCT ID: NCT01343225 Not yet recruiting - HIV Clinical Trials

Effect of a Non-tenofovir, Non-efavirenz-based HIV Regimen on Bone Density and Vitamin D Levels in African-American Patients With HIV Infection

Start date: May 2011
Phase: Phase 4
Study type: Interventional

2. Objectives 1. To determine the vitamin D status of African-American HIV patients who are HIV-treatment naïve. 2. To compare the effects of an efavirenz-containing regimen to a protease inhibitor regimen on 25-hydroxyvitamin D and 1,25 dihydroxyvitamin D3 levels. 3. To compare the effect on bone density of a tenofovir- and efavirenz-containing regimen to a regimen that does not contain these drugs. 4. To compare the efficacy of an alternative regimen (raltegravir, darunavir, ritonavir) to a standard once-daily regimen (tenofovir-emtricitabine-efavirenz). Hypothesis The investigators hypothesize that patients receiving efavirenz will be more likely to have lower 25-hydroxyvitamin D and 1,25 dihydroxyvitamin D3levels based on the fact that efavirenz is an inducer of CYP3A4 and CYP24 enzymes that degrade 25-hydroxyvitamin D and 1,25 dihydroxyvitamin D3, respectively, to inactive metabolites. The investigators speculate that patients on a tenofovir-containing regimen will be more likely to have progression of bone density loss compared to those in the non-tenofovir-containing regimen.

NCT ID: NCT01340950 Completed - HIV Infections Clinical Trials

Clinical Trial of Brain-Penetrating HIV Drugs to Prevent Cognitive Impairment in China

Start date: July 2010
Phase: Phase 4
Study type: Interventional

This primary aim of the project is to determine the association between antiretroviral therapy that better distributes into the central nervous system and prevention of HIV-associated neurocognitive impairment.

NCT ID: NCT01340196 Completed - HIV Infections Clinical Trials

Drug Drug Interaction of BI 201335 and Tenofovir

Start date: April 2011
Phase: Phase 1
Study type: Interventional

The objective of this study is to evaluate the drug-drug interaction potential between BI 201335 and concomitantly administered tenofovir which is used in treatment regimens for HIV infection and/or Hepatitis B infection. Results of this study will serve as a basis for guidance of dose adjustments or other precautionary measures when BI201335 and tenofovir are coadministered.

NCT ID: NCT01337583 Withdrawn - HIV Infections Clinical Trials

A Safety and Efficacy Trial of Dapivirine Vaginal Ring in Africa

Start date: July 2011
Phase: Phase 3
Study type: Interventional

This is a double-blind, randomized, placebo-controlled Phase III study to asses the safety and efficacy of a silicone elastomer vaginal ring containing 25mg of dapivirine.