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HIV clinical trials

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NCT ID: NCT02071082 Completed - HIV Clinical Trials

Efficacy and Safety of E/C/F/TAF (Genvoya®) in HIV-1/Hepatitis B Co-infected Adults

Start date: February 25, 2014
Phase: Phase 3
Study type: Interventional

This study will assess the efficacy, safety, and tolerability of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) fixed-dose combination (FDC) in human immunodeficiency virus (HIV)/hepatitis B virus (HBV) coinfected adults. Participants will be enrolled into two cohorts: - Cohort 1: HIV/HBV coinfected adults who are HIV treatment-naive and HBV treatment-naive - Cohort 2: HIV/HBV coinfected adults who are HIV-suppressed

NCT ID: NCT02068846 Completed - HIV Clinical Trials

BK Virus in Salivary Gland Disease: Treating the Potential Etiologic Agent

Start date: April 2014
Phase: Phase 3
Study type: Interventional

The purpose of this study is to analyze BK viral infection in salivary gland diseases; specifically, to determine a definitive relationship between BK Virus and HIV associated salivary gland disease (HIVSGD). Participants are adults HIV+SGD+ who will be randomized 1:1 to receive BK Virus antiviral (ciprofloxacin) or placebo for 28 days. Salivary function/protein secretion will be correlated with BK polyomavirus titers. It is expected that patients with HIV+SGD+ will have elevated oral BK polyomavirus viral loads and will benefit from Ciprofloxacin.

NCT ID: NCT02065986 Completed - HIV Clinical Trials

Pre-exposure Option for Reducing HIV in the UK.(PROUD)

PROUD
Start date: October 2012
Phase: Phase 4
Study type: Interventional

This study is looking at a new way to reduce the risk of catching HIV - Truvada-PrEP. To find out whether a daily tablet, Truvada, can safely reduce the risk of gay men catching HIV, we need to do a large trial in which half the men do not receive Truvada for one year. We do not know if gay men at risk of HIV are interested in taking Truvada, and if they are, whether they would be willing to wait a year before they can take it. The reason it may not be safe, is that taking Truvada-PrEP may lead to an increase in risk behaviour. This could mean there was more chance of catching HIV and other infections. As well as finding out if a large trial would be possible, this study will looks at other factors including: - Whether people using PrEP change the number of partners they have sex with - Whether people using PrEP change how often they use condoms - Whether PrEP leads to higher rates of other sexually transmitted infections (STIs). This information on changes in sexual activity over time is one of the most important aspects of the study, because we have never collected this before in the UK. This means we don't know what happens to people's sexual activity without PrEP! In October 2014 an interim analysis of the PROUD study data showed that pre-exposure prophylaxis (PrEP) was highly protective against HIV for gay men and other men who have sex with men (MSM) at high risk of infection. The PROUD Trial Steering Committee announced that participants on the deferred arm of the study, who had not yet started PrEP, should be offered the opportunity to begin PrEP ahead of schedule. As a result, we changed the study design and offered all enrolled participants the opportunity to access PrEP. All study participants will be followed up until study closure in October 2016

NCT ID: NCT02060162 Completed - HIV Clinical Trials

Antiretroviral Treatment Outcomes in HIV-HBV Co-infected Patients in Southern Africa

Start date: October 2013
Phase:
Study type: Observational

This is a prospective HIV cohort that aims to establish causes of liver disease among HIV-infected individuals in Zambia, including viral hepatitis and alcohol.

NCT ID: NCT02058719 Completed - HIV Clinical Trials

Immunosuppressive Effects of Smoking and HIV-1 on the Development of Lung Disease

Start date: March 2014
Phase:
Study type: Observational

This study plans to learn more about pulmonary complications of human immunodeficiency virus/acquired immunodeficiency syndrome (HIV/AIDS). Even though antiretroviral therapy (ART) has dramatically decreased the number of opportunistic infections and deaths in HIV infected patients, pulmonary complications (including chronic obstructive pulmonary disease (COPD) development and pneumonias resulting in decreased lung function) of HIV/AIDS continue to be a major cause of morbidity and mortality in this population. The mechanisms underlying the increased risk of COPD and decreased lung function in HIV infected individuals is not well understand and needs to be studied. The investigators hypothesize that the immunoregulatory consequences and immunosuppressive lung milieu secondary to HIV and cigarette smoke combine to increase the risk of lung infection and injury in HIV infected smokers, hastening the development of COPD. The mechanisms will be directly tested using blood and bronchial alveolar lavage (BAL) cells from smokers and nonsmokers with and without HIV infection.

NCT ID: NCT02056158 Completed - HIV Clinical Trials

HIV+ Alveolar Macrophage Oxidant-mediated Apoptosis of Pulmonary Endothelium

Start date: January 13, 2014
Phase:
Study type: Observational

In HIV+ cigarette smokers, with no prior history of pulmonary infections, emphysema is often developed at an earlier age and is a significant cause of morbidity despite treatment with antiretroviral drugs. Preliminary data gathered from HIV+ individuals that smoke cigarettes strongly support the hypothesis that the combination of HIV infection and smoking creates increased stress in the lower respiratory tract. To examine the underlying factors that contribute to the accelerated development of emphysema in this cohort, samples from the lower respiratory tract will be provided by HIV+ and HIV- subjects. The samples collected will serve as biomarkers for assessing the onset of emphysema.

NCT ID: NCT02055417 Completed - HIV Clinical Trials

Increasing Motivation for Antiretroviral Therapy Initiation: A Pilot Intervention

Start date: December 2010
Phase: N/A
Study type: Interventional

In this 3-year study, the investigators will develop and pilot test an intervention called Personal Approaches to Treatment Choices for HIV (PATCH). PATCH is a brief intervention designed to support participants' decision-making processes and enhance intrinsic motivation to initiate ART, using motivational interviewing (MI) techniques. The intervention will be targeted at HIV-positive African-American adults in inner-city Baltimore, Maryland who are suboptimally engaged in care and who endorse conspiracy beliefs about HIV or low readiness to begin ART. The specific aims are: (1) Develop and refine a manual for a brief MI intervention to support ART decision-making and reduce the likelihood of ART refusal: (2) Evaluate the feasibility and acceptability of implementing the PATCH intervention in a small sample of individuals who are African-American, recommended for ART but who are not current taking it, and who experience multiple barriers to ART adherence; and (3) Conduct a small randomized controlled pilot to test the potential efficacy of the PATCH intervention in producing positive attitudinal changes, including a reduction in conspiracy beliefs and perceived barriers to ART and stated readiness to begin ART.

NCT ID: NCT02050763 Completed - HIV Clinical Trials

Assessing the Impact of an Intervention to Prevent Intimate Partner Violence and HIV in Uganda

SHARE
Start date: February 2005
Phase: N/A
Study type: Interventional

Intimate partner violence (IPV) is a precursor to and consequence of HIV infection. Few interventions combining HIV and IPV prevention have been evaluated and none has significantly decreased both outcomes. A cluster-randomized trial was conducted in Rakai, Uganda. Four intervention arm clusters (N=5,339) received an IPV prevention intervention (the Safe Homes and Respect for Everyone (SHARE) Project), enhanced HIV testing and treatment and routine HIV services provided by Rakai Health Sciences Program (RHSP). Seven control arm clusters (N=6,112) received standard of care HIV services alone. Baseline and two follow-up visits were conducted via the Rakai Community Cohort Study between 2005 and 2009. Primary outcomes were past year emotional, physical and sexual IPV and HIV incidence. Secondary outcomes included past year intimate partner rape/forced sex, number of total and extra-marital sex partners, alcohol use surrounding sex, condom use, discussion about condom use, partner's disclosure of HIV status and respondent's disclosure of HIV status. Analysis was by intention-to-treat. Modified Poisson regression was used to estimate prevalence risk ratios (PRR) to detect the impact of the intervention on IPV and secondary outcomes. Poisson regression was used to estimate incidence rate ratios (IRR) of HIV acquisition per 100 person years (py). Our study had three research aims and related hypotheses. Aim 1 was to assess the impact of SHARE + RHSP community services on report of victimization from and perpetration of physical and/or sexual IPV in the past 12 months, compared to the impact of RHSP community services alone. Hypothesis 1(a): SHARE intervention will reduce women's reports of IPV victimization in intervention vs. control arms. Hypothesis 1(b): SHARE intervention will reduce men's reports of IPV perpetration in intervention vs. control arms. Aim 2 was to assess the impact of SHARE + RHSP services on report of sexual risk behaviors among men and women compared to the impact of RHSP community services alone. Hypothesis 2(a): SHARE intervention will reduce selected sexual risk behaviors in the intervention vs. control arms. Aim 3 was to assess the impact of SHARE + RHSP services on HIV incidence compared to the impact of RHSP community services alone. Hypothesis 3(a): Incidence of HIV will be lower in the intervention vs. control arms.

NCT ID: NCT02043080 Completed - HIV Clinical Trials

Optimizing Clinical Outcomes in HIV-Infected Adults & Children

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

This is a study to evaluate Xpert MTB/RIF as the first-line TB diagnostic test in HIV-infected adults and pediatric patients as a means to obtain faster, more accurate TB diagnosis.

NCT ID: NCT02043041 Completed - HIV Clinical Trials

Evaluation of the Quality of Self-collected Blood Spot Specimens for Laboratory HIV Testing - An InvolveMENt Sub Study

Start date: January 2014
Phase: N/A
Study type: Observational

We will invite a convenience sample of up to 45 enrolled subjects to participate in an optional, self-administered blood specimen collection procedure to determine optimal procedures for collection.