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HIV Infections clinical trials

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NCT ID: NCT03635788 Not yet recruiting - HIV Infections Clinical Trials

Evaluating Long-Acting Antiretroviral Therapy in Non-Adherent HIV-Infected Individuals

Start date: October 3, 2018
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare the efficacy, safety, and durability of two different strategies to treat participants with a history of sub-optimal adherence and control of their HIV infection: long-acting (LA) antiretroviral therapy (ART) and all-oral standard of care (SOC).

NCT ID: NCT03626467 Not yet recruiting - HIV Infections Clinical Trials

A Clinical Trial to Evaluate the Immunogenicity of the Nonavaventh Vaccination Against the Virus of Human Papiloma in Men Infected by Hiv Who Have Sex With Men. GESIDA 10017

Start date: August 15, 2018
Phase: Phase 4
Study type: Interventional

Phase IV, open, multicenter and single-arm clinical trial designed to evaluate the immunogenicity of the HPV9v vaccine in men with HIV infection (HIV +) who have sex with men (MSM)

NCT ID: NCT03622177 Not yet recruiting - HIV I Infection Clinical Trials

Role of the IL33/Amphiregulin Pathway as a Potential Therapeutic Target in HIV Infection

Start date: September 2018
Study type: Observational

Interleukin33 organize local immune reactions, especially at epithelial barriers. ST2 is the IL33 receptor. The sST2 rate is higher for patient living with HIV and is an independent predictable factor of mortality. Interleukin33 induce tissue Treg ST2+ lymphocytes proliferation and amphireguline production. Amphireguline is member of epithelial growth factors family, which contributes to tissue repair, and fibrose. Amphireguline also helps immunosuppressives functions. Targetting amphiregulin for people living with HIV who has poor restauration of LTCD4+ could be a future therapy.

NCT ID: NCT03619278 Not yet recruiting - HIV Infections Clinical Trials

Evaluating a Combination of Immune-based Therapies to Achieve a Remission of HIV Infection

Start date: November 1, 2018
Phase: Phase 1/Phase 2
Study type: Interventional

A phase I/IIa, multinational, multicentric (IDIBAPS, IRSICAIXA, AARHUS, VUB, APHP), randomised, balanced by centre (to include participants from the 4 arms), open-label, controlled clinical trial. Each participant will be followed up a different time according to study arm: a minimum of 38 weeks in arm I, 31 weeks in arm II, 54 weeks in arm III and 26 weeks in the arm 4. The study duration will be 104 weeks from inclusion of the first participant. Participants will be randomised to one of the following 4 arms: - Arm 1 (study): 14 participants will receive 3 vaccines of HIVARNA01.3 prime, 2 MVA-vectored vaccine boosts, 1 dose of 10-1074 antibodies and 3 doses of romidepsin - Arm 2 (study): 14 participants will receive 5 vaccines of HIVARNA01.3, 1 dose of 10-1074 antibodies and 3 doses of romidepsin - Arm 3 (study): 14 participants will receive 5 vaccines of personalized RNA vaccine (HIVACAR01), 1 dose of 10-1074 antibodies and 3 doses of romidepsin - Arm 4 (control): 14 participants 1 dose of 10-1074 antibodies and 3 doses of romidepsin

NCT ID: NCT03618511 Not yet recruiting - Clinical trials for Human Immunodeficiency Virus (HIV) Infection

Interventions to Improve HIV Antiretroviral Therapy Adherence

Start date: August 2018
Phase: N/A
Study type: Interventional

This study will explore whether financial incentives and reminders help improve anti-retroviral therapy (ART) adherence among HIV infected individuals in a resource-limited environment. The interventions will be randomized in the study population in a cross-cutting design, with a control group, a financial incentive treatment group, a reminder phone call treatment group, and a treatment group that receives both reminder calls and a financial incentive. This design allows estimation of complementarities between the two interventions. The primary outcomes of interest for this study will be the adherence to ART, measured by attendance rates at clinic appointments and refill collection rates.

NCT ID: NCT03618056 Not yet recruiting - HIV Infections Clinical Trials

Evaluating HIV-1 Neutralization Antibody Breadth in Response to HIV gp120 Protein Vaccine in HIV-uninfected Adults With Quiescent Systemic Lupus Erythematosus

Start date: October 15, 2018
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the breadth and potency of HIV-1 neutralizing antibody (nAb) responses and examine the safety and tolerability of an HIV gp120 protein vaccine (AIDSVAX® B/E) in HIV-uninfected adults diagnosed with Systemic Lupus Erythematosus (SLE) who have stable disease.

NCT ID: NCT03617874 Not yet recruiting - Clinical trials for Human Immunodeficiency Virus Transmission

PC4PrEP: Integrating PrEP Into Primary Care

Start date: September 1, 2018
Phase: N/A
Study type: Interventional

Oral pre-exposure prophylaxis (PrEP) has been proven effective in reducing HIV infection in high-risk men who have sex with men, heterosexually active women and men, and injecting drug users. Despite its 2012 approval by the FDA and the development of Centers for Disease Control and Prevention (CDC) clinical guidelines, PrEP uptake has been limited. Significant impediments to PrEP implementation include: system barriers (lack of a medical "home" and of models for implementing PrEP); provider barriers (difficulty identifying those likely to benefit from PrEP, inexperience with PrEP, and concerns about adherence and risk compensation); and user barriers (lack of awareness of PrEP, inability to access providers comfortable with prescribing PrEP, and concerns about stigma and side effects). Cost is not a barrier in New York State, where PrEP is covered by many insurance plans, including Medicaid. Primary Care for PrEP (PC4PrEP) is a structural, multilevel intervention that will integrate PrEP into primary care practices that care for underserved communities in the Bronx, NY, an epicenter of continuing HIV infection in the US. PC4PrEP will develop an organizational protocol for prescribing PrEP in primary care; identify high-risk individuals in primary care clinics and community HIV testing sites using a new PrEP Eligibility Tool; link them to primary care providers (PCPs) who can provide PrEP; and counsel potential users about PrEP both before they receive a prescription (to enhance receptivity), and after they initiate PrEP (to enhance adherence). In the course of this study, investigator(s) will (1) develop and pilot PC4PrEP; (2) implement and evaluate it in "real-world" settings (Federally Qualified Health Centers; FQHCs) on objective outcomes as well as provider and patient reports; and (3) present a new model, the PrEP Cascade that - as with the HIV Care Cascade for HIV+ populations - may be used to evaluate the impact of PrEP programs in the US and other countries. PC4PrEP is consistent with CDC and New York State Department of Health (NYSDOH) Guidelines and the Affordable Care Act in integrating PrEP into primary care practices and is responsive to recent 2014 NYSDOH recommendations which now position PrEP as a first-line intervention for MSM and transgender women who engage in ongoing anal sex without condoms, HIV- partners in sero-discordant relationships, and high-risk heterosexual women in high seroprevalence areas.There are two Specific Aims: (1) Finalize the PC4PrEP intervention and, in a clinic-randomized Phase 2 futility trial, assess whether it shows promise for increasing PrEP prescription rates in the Bronx, NY; and (2) Identify strengths and limitations of PC4PrEP in two ways: (a) through a mixed-methods process evaluation PrEP-eligible patients and PCPs, counselors and navigators; and (b) by identifying "fall-off" at each step of the PrEP Cascade.

NCT ID: NCT03617705 Not yet recruiting - Clinical trials for Human Immunodeficiency Virus (HIV)

Alcohol Monitor Validation

Start date: August 2018
Phase: N/A
Study type: Interventional

This study will validate a wrist-worn alcohol monitor (BACtrack Skyn) in both laboratory and real-life settings.

NCT ID: NCT03615183 Not yet recruiting - Clinical trials for Human Immunodeficiency Virus

A Study of MK-8527 in Human Immunodeficiency Type 1 Virus (HIV-1) Infected Participants (MK-8527-002)

Start date: October 1, 2018
Phase: Phase 1
Study type: Interventional

This study will evaluate the antiretroviral activity of MK-8527 inHIV-1 infected, ART-naive participants. The primary hypothesis is at that MK-8527 has superior antiretroviral activity compared to placebo, as measured by change from baseline in plasma HIV-1 ribonucleic acid ([RNA] at 168 hours postdose.

NCT ID: NCT03601806 Not yet recruiting - Skin Kaposi Sarcoma Clinical Trials

Pomalidomide in Treating Patients With Kaposi Sarcoma and Human Immunodeficiency Virus Infection

Start date: October 31, 2018
Phase: Phase 2
Study type: Interventional

This phase II clinical trial studies the side effects of pomalidomide and how well it works in treating patients with Kaposi sarcoma and human immunodeficiency virus (HIV) infection. Biological therapies, such as pomalidomide, may stimulate the immune system in different ways and stop tumor cells from growing and it may also block the growth of new blood vessels necessary for tumor growth.