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NCT ID: NCT03242954 Completed - HIV Clinical Trials

Innovative Approaches for Minor Consent: Consent 2.0

Start date: November 7, 2017
Phase: N/A
Study type: Interventional

The purpose of this study is to examine how the consent process affects the acceptability of participation in biomedical HIV prevention trials, from the perspective of behaviorally high-risk minors and the parents of minor adolescents.

NCT ID: NCT03237689 Completed - Hiv Clinical Trials

Effects of Glucocorticoids on Cognition in HIV-infected Women

MsSCORE
Start date: November 20, 2017
Phase: Early Phase 1
Study type: Interventional

Despite treatment with antiretroviral therapy, women living with HIV continue to experience cognitive impairment. Psychological risk factors, including stress, impair cognition more in HIV-infected women than HIV-uninfected women. This study plans to examine a novel intervention for cognitive dysfunction that targets the mechanisms by which stress negatively affects cognitive functioning.

NCT ID: NCT03225118 Completed - HIV Clinical Trials

Impact of a Short-Term Analytical Treatment Interruption and Re-Initiation of Antiretroviral Therapy on Immunologic and Virologic Parameters in HIV-Infected Individuals

Start date: July 17, 2017
Phase:
Study type: Observational

Background: The immune system helps the body fight off disease. Most people infected with HIV cannot control the infection and need daily medicine. Combination antiretroviral therapy (cART) are drugs taken to prevent HIV infection from damaging the immune system. Researchers want to study why some people develop resistance to the drugs or have permanent side effects. Objective: To study the impact of a short-term treatment stop on HIV that persists even while taking cART. Eligibility: Adults 18-65 years old with HIV who are being treated with cART Design: - Participants will first be screened with a physical exam and medical history. They may have a chest x-ray. They will have heart, blood, and urine tests. - At the baseline visit, participants will repeat the screening tests except the x-ray. They will get counseling about HIV and risk behavior. - Participants will have leukapheresis. Blood will be removed through a needle in one arm. A machine will separate white blood cells from the rest of the blood. The remainder of the blood will be returned to the body by a different needle. - Participants will stop their current treatment on day 0. They will visit the clinic each week until they meet the criteria to restart cART. These visits will have the same procedures as the baseline visit. - Before restarting cART, most participants will have leukapheresis. - After restart, participants will be seen weekly for 4 weeks and then monthly for about 11 months. Participants will have blood drawn, physical exam, and medical history. They will have leukapheresis 2 more times over 1 year.

NCT ID: NCT03217058 Completed - Depression Clinical Trials

Computerized Substance Use and Depression Screening and Behavioral Treatment in HIV Primary Care

PACE
Start date: August 1, 2017
Phase: N/A
Study type: Interventional

Substance use disorders (SUDs), depression and anxiety in HIV-infected patients result in poor HIV outcomes, yet are often unrecognized and untreated. To address these problems, this study examines the implementation and effectiveness of a clinical intervention consisting of self-administered tablet-based SUD and depression screening at routine HIV primary care clinic visits, followed by evidence-based treatments for SUD, anxiety and depression delivered by a behavioral health specialist. If successful, this study has potential to reduce SUD-, anxiety- and depression-related problems and reduce HIV treatment disparities for patients with these comorbidities.

NCT ID: NCT03205566 Completed - Hiv Clinical Trials

Time to Protection and Adherence Requirements of Raltegravir With or Without Lamivudine in Protection From HIV Infection

R-PrEP
Start date: September 19, 2017
Phase: Phase 4
Study type: Interventional

This study evaluates whether a 7-day course of Raltegravir 400mg bd or Raltegravir 400mg/lamivudine 150mg bd can prevent HIV from infecting genital tissue and will relate the level of drug in the blood to the level of drug in genital tissue and to the ability to of HIV to infect genital tissue. As well as determining whether these regimes can provide ex vivo protection against HIV, this study will also determine speed to provision of protection and a 48 hour PK/PD decay profile of Raltegravir following drug cessation after attaining steady state concentrations. The results will also inform all future HIV pre-exposure prophylaxis studies of Raltegravir and form the basis for large scale clinical trials without the need for tissue sampling. To date, efficacy studies assessing PrEP regimens have utilized HIV-acquisition endpoints with the consequence being such studies are required to be large in subject number in order to power observations. In addition the study will provide for the first time data on HIV protection rather than just Raltegravir drug levels in tissue, and allow assessment of the possibility of Raltegravir being used as an intermittent dosing regimen in PrEP.

NCT ID: NCT03204617 Completed - HIV Clinical Trials

Safety and Immunogenicity Study of DNA.HTI, MVA.HTI and ChAdOx1.HTI in HIV-1-positive Patients (AELIX-002)

Start date: July 7, 2017
Phase: Phase 1
Study type: Interventional

The AELIX-002 study aims to evaluate the safety and the immunogenicity of an heterologous prime-boost regimen with DNA.HTI, MVA.HTI and ChAdOx1.HTI in early diagnosed and treated HIV-1 positive individuals, males and females,18-60 years of age.

NCT ID: NCT03201510 Completed - HIV Clinical Trials

Feasibility of HIV Prevention Cohort Studies Among Men Who Have Sex With Men in Sub-Saharan Africa

Start date: June 12, 2015
Phase:
Study type: Observational

This study aims to determine the feasibility of recruiting and retaining men who have sex with men (MSM) in a multi-country prospective cohort study in preparation for human immunodeficiency virus (HIV) prevention studies in sub-Saharan Africa (SSA).

NCT ID: NCT03200054 Completed - Hiv Clinical Trials

Postpartum Adherence Clubs for Antiretroviral Therapy

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

South Africa is implementing the policy of universal initiation of lifelong antiretroviral therapy (ART) in all HIV-infected pregnant women regardless of CD4 cell count or disease stage ("Option B+"). There is a recognised need for innovative models of service delivery to support adherence and retention in care in this group, particularly during the postpartum period. The investigators are conducting a pragmatic randomised control trial to compare virological outcomes 24 months postpartum in two models of service delivery for provision of HIV care and treatment services postpartum in women who initiated ART during pregnancy: local adult ART clinics and community-based adherence clubs.

NCT ID: NCT03199027 Completed - Hiv Clinical Trials

Timing of Referral to Adherence Clubs for Antiretroviral Therapy

TRAC
Start date: January 18, 2017
Phase: N/A
Study type: Interventional

Following the announcement of the global "90-90-90" strategy, there is a huge need in South Africa for effective well-developed scaled-up models of ART (anti-retroviral therapy) delivery that aim to improve patient adherence and viral suppression. The ART adherence club is one such model of service delivery. The investigators are conducting a pragmatic randomised control trial to compare virological outcomes 12 months post-ART initiation between arms: individuals referred to the Adherence club at 4 months post-ART initiation (early referral) and individuals referred to the Adherence club at 12 months post-ART initiation (delayed referral). Individuals with delayed Adherence club referral will continue to attend the ART clinic as per the Standard-of-Care.

NCT ID: NCT03194880 Completed - HIV Clinical Trials

Alere COMBO and Alere q Detect in an HIV PrEP Program in Thailand

Start date: December 8, 2016
Phase:
Study type: Observational

Two new rapid HIV tests by Alere™ have the potential to substantially decrease the window period for rapid tests. First, the Alere™ HIV Combo is a rapid fourth generation test. The performance in a laboratory based setting was recently assessed at the Thai Red Cross Anonymous Clinic Laboratory in Bangkok, Thailand (personal communication). Of 50 confirmed acute HIV samples, Alere™ HIV Combo could detect 37 (74%), while none of these 50 cases could be identified by the currently used third generation tests. These data have not yet been published, but the preliminary results indicate a very favorable performance of the Alere™ HIV Combo in a facility-based laboratory setting. Second, the Alere™ q HIV-1/2 Detect is a qualitative, cartridge based, nucleic acid amplification test designed for Point of Care use. Data from several early infant diagnosis studies in Sub-Saharan African countries have assessed the performance of the Alere™ q HIV-1/2 Detect. The test was performed in the field, by a range of health professionals, from nurses and laboratory technicians to medical doctors. The pooled analysis showed a sensitivity of 99.07% (95%CI 95.48 - 99.95%) and a specificity of 99.94% (99.72-100%).