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NCT ID: NCT02477527 Completed - HIV Clinical Trials

Atripla to Stribild Switch Study to Evaluate Sleep Disturbances

Start date: February 2015
Phase: Phase 4
Study type: Interventional

Switch patients from Atripla to Stribild will be evaluated to see if patients have less sleep disturbances.

NCT ID: NCT02476071 Completed - HIV Clinical Trials

Evaluating Demand Generation for Safe Voluntary Male Circumcision (VMC) for HIV Prevention (Stylish Man), Rakai, Uganda

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

The study, funded by the Bill and Melinda Gates Foundation, will test a novel demand generation strategy, "Stylish Man", to increase uptake of safe voluntary male circumcision (VMC) for HIV in Rakai, Uganda. With President's Emergency Fund for AIDS Relief (PEPFAR) funds, the Rakai Health Sciences Program (RHSP) provides VMC in Rakai District, Uganda. The investigators' ongoing 54 village Rakai Community Cohort Study (RCCS), with community HIV prevalence ranging from 6% to 42%, provides longitudinal data on rates of VMC coverage and on HIV incidence. The investigators have preliminary evidence that VMC is reducing HIV incidence in Rakai, but coverage remains suboptimal (as elsewhere in Africa), reducing program impact. The investigators' data suggest that VMC "supply" is not the limiting factor, but that there is a "deficit in demand". Based on extensive qualitative research, the investigators have developed and piloted an innovative male-focused VMC demand generation strategy, the "Stylish Man Program" (SMP). The VMP strives to "demedicalize" VMC by de-emphasizing health-focused messages and instead stressing "taking charge of your life". The SMP has two distinct but related elements: (1) mass media (MM) via radio and posters; and (2) community-level mobilization via the "Stylish Man Event" (SMEvent) which includes multimedia media (the Stylish Van, videos, music, health promoters) into which the investigators have embedded VMC promotion, and immediate access to services. In this study, the investigators will conduct a one year cluster randomized trial of MM plus SMEvents (intervention arm) compared to MM alone (control), in 20 RCCS communities, half randomzied to the intervention and half to the control arm. The primary outcome will be intent-to-treat community-level rates of VMC coverage by arm, ie., the percentage of non-muslim men in each arm who accept and adopt MMC. (Over 95% of Muslim men in Rakai already receive male circumcision in infancy.) As secondary outcomes, we will also monitor rates of key behaviors and HIV incidence, and compare them between arms and to rates observed in communities in each arm prior to study initiation.

NCT ID: NCT02475629 Completed - HIV Clinical Trials

Ibalizumab Plus Optimized Background Regimen in Patient With Multi-Drug Resistant HIV

Start date: August 2015
Phase: Phase 3
Study type: Interventional

This Phase 3, single arm, multicenter study will evaluate the safety and effectiveness of ibalizumab in treatment-experienced patients infected with multi-drug resistant HIV-1.

NCT ID: NCT02474992 Completed - HIV Clinical Trials

The Kanyakla Study: a Microclinic Social Network Intervention for Promoting Engagement and Retention in HIV Care

Start date: January 2016
Phase: N/A
Study type: Interventional

The purpose of this randomized controlled trial is to compare a social network-based behavioral intervention known as microclinics to standard HIV clinical care alone in helping patients receiving HIV care on Mfangano, Remba and Ringiti Islands, Kenya remain adherent to clinic appointments. The study is designed to evaluate the effectiveness of microclinics on reducing gaps in clinical care, HIV viral load and HIV-related stigma, compared to standard HIV clinical care alone. By doing this research study, the investigators hope to learn whether microclinics are a useful social strategy for improving delivery of HIV treatment in rural Kenya.

NCT ID: NCT02471326 Completed - HIV Clinical Trials

VRC-HIVMAB060-00-AB (VRC01) in People With Chronic HIV Infection Undergoing Analytical Treatment Interruption

Start date: July 13, 2015
Phase: Phase 1
Study type: Interventional

Background: - A combination of daily drugs (called cART) can keep human immunodeficiency virus (HIV) very low for a long time. But cART can lose effectiveness and cause permanent side effects. If treatment stops, HIV levels go up again. Researchers want to see if a new product can control HIV levels when a person is off cART. Objective: - To see if the new product VRC01 is safe and can control the HIV level in the blood when a person is not taking cART. Eligibility: - Adults ages 18-65 with HIV who are willing to interrupt their treatment for at least 24 weeks. Design: - Participants will be screened with: - Physical exam - Medical history - Heart tests - Blood and urine tests. - Their HIV drugs may be switched. They will keep taking them until a few days after Visit 1. - Visit 1: Repeat screening procedures. - Participants will also have genetic testing and leukapheresis. For this, blood will be removed through a needle in one arm and circulated through a machine that removes white blood cells. The rest of the blood is returned through a needle in the other arm. - They will get the first study drug dose through a thin tube in an arm vein for about 1 hour. - For 24 weeks, participants will have 16 visits. They will have blood drawn every visit. At some visits they will repeat the screening procedures and get another VRC01 dose. They may have another leukapheresis. - Four weeks after the last dose, participants will restart their cART. For 20 weeks, they will have monthly visits to repeat the screening procedures and discuss new symptoms.

NCT ID: NCT02460900 Completed - HIV Clinical Trials

Optimizing Smoking Cessation for People With HIV/AIDS Who Smoke

Start date: July 2016
Phase: Phase 3
Study type: Interventional

The single greatest health behavior change that could improve cardiovascular morbidity and associated mortality is to assist people living with HIV/AIDS who smoke to quit. The investigators will use a factorial design to evaluate the most promising behavioral and pharmacologic treatments aimed at achieving maximal efficacy for smoking cessation among people living with HIV/AIDS who smoke. Results of this study will provide crucial, real world evidence of the best way for healthcare providers to help smokers living with HIV/AIDS quit smoking.

NCT ID: NCT02457689 Completed - HIV Clinical Trials

The Safety and Immunogenicity of the DNA-GTU Vaccine Administered to HIV-infected Patients on ART vs Placebo

CUTHIVTHER001
Start date: July 2015
Phase: Phase 1/Phase 2
Study type: Interventional

CUT*HIVTHER 001 is a randomised placebo-controlled Phase I/II study aimed at exploring the safety and immunogenicity of two different modes of delivery of a GTU® DNA plasmid vaccine (GTU®-multiHIV B clade) in HIV infected volunteers on antiretroviral therapy (ART): - Transcutaneous (TC) delivery to enhance intramuscular delivery and - Electroporation (EP) enhanced intramuscular delivery Participants will be randomised 1:1:1 to TC:EP:saline for the purposes of analysis. Half the saline group will receive TC saline and half will receive EP saline. 30 HIV infected male and female volunteers aged 18-45 years, who have been on ART for at least 6 months with 2 or more HIV plasma viral load measurements < 50 copies HIV RNA/ml prior to enrolment. The investigational HIV-1 vaccine GTU®-MultiHIV B clade encodes for a MultiHIV antigen which is a synthetic fusion protein consisting of full-length polypeptides of Rev, Nef, Tat, p17 and p24 and containing more than 20 Th and CTL epitopes of protease, reverse transcriptase (RT) and gp160 regions of the HAN2 HIV-1 B clade. Vaccine is provided in sealed vials at 2mg/ml, and a single 1ml IM injection of 2mg GTU®-MultiHIV DNA IM (into the thigh) is required to deliver a 2mg dose. Individuals in Group 2 will receive a further 0.4mg GTU®-MultiHIV DNA in 0.2ml administered by TC, a novel needle-free method of vaccine delivery.

NCT ID: NCT02457494 Completed - HIV Clinical Trials

Kidney Stone Risk Factors in Patients Infected With HIV

CALVIH
Start date: May 2015
Phase:
Study type: Observational

The purpose of this study is to define the cause of renal stones and the risk pattern for recurrence of renal stones episodes (any kind of stones) in HIV1 patients.

NCT ID: NCT02455583 Completed - HIV Clinical Trials

An Assessment of an HIV Prevention Intervention (Project AIM) Among Junior Secondary School Students in Eastern Botswana

AIM
Start date: August 2014
Phase: N/A
Study type: Interventional

The purpose of this study is to examine the effectiveness of an HIV prevention intervention called Project AIM (Adult Identity Mentoring) to delay onset of sexual activity and reduce sexual risk behaviors among students (approximate ages 12- 17 years) in junior secondary schools (Form 1 - 3) in Eastern Botswana.

NCT ID: NCT02454816 Completed - HIV Clinical Trials

Introduction Study of Dual HIV & Syphilis Rapid Diagnostic Tests in Antenatal Clinics in Colombia

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

Global and regional initiatives have been launched for the dual elimination of mother-to-child transmission (MTCT) of HIV and syphilis. As one of the important components in the initiatives, early detection and timely intervention of pregnant women infected with HIV and/or syphilis is critical. In order to improve the number of women tested and treated, innovative strategies are needed. Serologic tests are the diagnostic tests of choice for HIV and syphilis. There are two types of serological tests (treponemal and non-treponemal tests) for diagnosis of syphilis. These generally require venous blood for screening of symptomatic and asymptomatic patients. In addition, these tests are technically demanding, and require laboratory equipment which is not widely available in most resource-limited settings. Recently, Rapid diagnostic tests (RDTs) that can be used at point-of-care for simultaneously detecting antibodies to HIV and syphilis (dual HIV & syphilis treponemalRDTs) using serum/plasma, venous whole blood, or finger-stick whole blood have been developed and are now commercially available. In low-resource settings, a combination of two or three rapid diagnostic tests (RDTs), in which one screening test with a second test to confirm initial positive results or two RDTs in parallel with a third test as a tiebreaker for discordant samples, can be used to diagnose HIV on finger-stick blood. To date, there are few data on the implications of using these RDTs in the antenatal clinic settings, although they have been evaluated in laboratory-based studies and shown encouraging sensitivities and specificities as compared with reference laboratory tests. The objective of this research is to assess the uptake of syphilis testing after the introduction of dual HIV/syphilis rapid testing as compared to single rapid syphilis testing in antenatal clinics in Colombia. The secondary objectives of the study are: To determine the uptake of treatment of syphilis after the intervention, To determine the uptake of HIV testing in ANC attendees after the intervention, To explore the acceptability of dual HIV/syphilis RDTs by ANC attendees and health workers, To assess the organizational and socio-cultural advantages and barriers to introduction with a aim of sustainable adoption of dual HIV/syphilis RDTs in antenatal services, To determine the workload and cost implications of introduction of dual HIV/syphilis RDTs in antenatal services