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HIV Infections clinical trials

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NCT ID: NCT04650269 Completed - HIV Infections Clinical Trials

Implementation of Onsite, Rapid ART Initiation Among People Who Inject Drugs Living With HIV at Syringe Services Program

Start date: March 4, 2021
Phase: Phase 4
Study type: Interventional

The purpose of this study is to see if providing HIV medicine right away at the IDEA Syringe Services Program will help the participant start and remain in HIV care, including having no detectable HIV in the participant's blood.

NCT ID: NCT04648280 Recruiting - Clinical trials for HIV Infections With Multi Drug Resistant Virus

Safety and Pharmacokinetics Evaluation of Fostemsavir + (OBT) in HIV-1 Infected Children and Adolescents Who Are Failing Their cART and Have Dual- or Triple-class Antiretroviral Resistance

Start date: June 30, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

In the SHIELD study, the study sponsor seeks to assess safety, PK and antiviral activity for children and adolescents with dual or triple class resistance. It will also assess the acceptability and swallowability of formulation among the pediatric population. The dose selection of FTR for children and adolescents ≥20kg utilized a population pharmacokinetic (POP PK) model-based approach to achieve similar adult TMR exposures following FTR 600mg BID administration with combination therapy that was demonstrated to be safe and effective in the FTR Phase 3 BRIGHTE study in HTE patients.

NCT ID: NCT04648046 Recruiting - HIV Infections Clinical Trials

CAR-T Cells for HIV Infection

Start date: March 1, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

This is a limited-center, open-label dose escalating phase I/IIa study of autologous T cells expressing LVgp120duoCAR molecules in people with HIV infection. It will follow a 3+3 design. Dose escalation decisions will be made when a minimum of three participants have completed the safety-evaluation period (45 days) at a given dose level. Cohort 1 will undergo infusion of a single low-dose regimen of LVgp120duoCAR-T cells. Cohort 2 will undergo non-ablative conditioning with cyclophosphamide, followed by infusion of a single low-dose regimen of LVgp120duoCAR-T cells. Cohort 3 will undergo non-ablative conditioning with cyclophosphamide, followed infusion of a single high-dose regimen of LVgp120duoCAR-T cells. Following administration of the experimental therapy, HIV medications will be paused for participants in each group during an analytic treatment interruption.

NCT ID: NCT04644029 Active, not recruiting - Prophylaxis Clinical Trials

Oral ISL QM as PrEP in Cisgender Women at High Risk for HIV-1 Infection (MK-8591-022)

Impower-022
Start date: February 24, 2021
Phase: Phase 3
Study type: Interventional

This study will evaluate whether oral islatravir (ISL) is effective in preventing Human Immunodeficiency Virus Type 1 (HIV-1) infection in women at high-risk for HIV-1 infection. The study will compare oral ISL taken once a month with standard-of-care medication for prevention of HIV-1 infection, emtricitabine/tenofovir disoproxil (FTC/TDF), taken once per day. The primary hypothesis is that oral ISL is more effective than FTC/TDF at reducing the incidence rate per year of confirmed HIV-1 infections.

NCT ID: NCT04641013 Active, not recruiting - HIV Infections Clinical Trials

Age-related Clonal Haematopoiesis in an HIV Evaluation Cohort (ARCHIVE)

ARCHIVE
Start date: December 5, 2017
Phase:
Study type: Observational [Patient Registry]

The ARCHIVE study is an observational longitudinal cohort study of people with and without HIV who are over the age of 55. The duration of the study is planned for 10 years, with study visits every 1-2 years. The objectives of the study are to evaluate genomic and other factors associated with aging, stratified by HIV status.

NCT ID: NCT04636736 Not yet recruiting - HIV Infections Clinical Trials

HIV Drug Resistance Pattern Due to Migration in Poland

Start date: January 1, 2021
Phase:
Study type: Observational

According to the Polish governmental statistics migration of people from Ukraine to Poland is growing and only in year 2020 have come to Poland about a quarter of a million of Ukrainian migrants. As well, more than 40% of those diagnosed with HIV infection in the European Union (EU)/European Economic Area (EEA) in 2018 were also migrants, originating from countries with generalized HIV epidemics, such as Ukraine. Antiretroviral treatment should be started, based, among others, on epidemiological data and evidence of presence of drug resistance mutations in a the population.

NCT ID: NCT04636437 Recruiting - HIV Infections Clinical Trials

Doravirine for Persons With Excessive Weight Gain on Integrase Inhibitors and Tenofovir Alafenamide

Start date: May 20, 2021
Phase: Phase 4
Study type: Interventional

The primary purpose of this study is to see if people with HIV who had a significant weight gain after starting INSTI (integrase strand transfer inhibitor)+TAF/FTC (tenofovir alafenamide/emtricitabine) (TAF/3TC (lamivudine)) regimen could either slow their rate of weight gain or lose weight within about 1 year if they switch to a regimen containing doravirine (DOR; a newer, non-nucleoside reverse transcriptase inhibitor medication). The study will also try to see if participants changing from TAF/FTC (or TAF/3TC) to TDF/FTC (or TDF/3TC) will experience less additional weight gain or a reduction in overall body weight at 48 weeks compared to persons continued on an INSTI + TAF/FTC (or TAF/3TC) combination. INSTINs assessed in A5391 include bictegravir (BIC), dolutegravir (DTG), or raltegravir (RAL). Additionally, the study will see whether a change in ART can affect things like waist circumference, metabolic and cardiovascular health, fat and lean mass body composition, bone health, and maintenance of virologic suppression. Finally, the study will look at the safety and tolerability of DOR plus either TAF/FTC (or TAF/3TC) versus TDF/FTC (or TDF/3TC).

NCT ID: NCT04630002 Completed - HIV Infections Clinical Trials

Drug-drug Interaction (DDI) Study of GSK3640254 With Darunavir/Ritonavir (DRV/RTV) and Etravirine (ETR)

Start date: October 28, 2020
Phase: Phase 1
Study type: Interventional

This is an open-label, single-sequence, multiple-dose, 3 cohort study to investigate the effects of DRV/RTV and/or ETR on the pharmacokinetics (PK) of GSK3640254 and the effects of GSK3640254 on the PK of DRV/RTV and/or ETR. This study will aid in understanding these interactions and resulting changes in exposure (if any) when given in combination with GSK3640254.

NCT ID: NCT04621760 Completed - Clinical trials for Sexually Transmitted Diseases

The OPENS Trial: Offering Women PrEP (Aim 1)

Start date: May 3, 2021
Phase: N/A
Study type: Interventional

To address the significant barriers to PrEP implementation for those who were assigned female at birth and self-identify as a woman and address racial inequities in HIV prevention in the United States (US), a novel approach that accounts for multilevel influences is necessary. This study is one part of a multi-component project and involves a patient-level intervention in one public health family planning clinic in Duval County Florida, where the majority of patients are women of color. The area has one of the highest HIV incidence rates among women in the US. The investigators developed a tablet-based decision support tool that helps users learn about HIV vulnerabilities and HIV prevention strategies to inform how they consider options for reducing their likelihood of acquiring HIV. Participants will be randomized to use the HIV decision support tool before their visit or standard counseling (without the use of the tool) and will be surveyed about the use of the tool, experiences with HIV prevention counseling, and intentions about the use of HIV prevention. A subset of participants, all individuals who self-identify as a woman and as Black or Latina, will also complete a post-clinic visit interview. The investigators will follow-up with participants at three months following their initial visit to see if they have initiated the HIV prevention method(s) they chose at their visit. The main outcomes will include a quantitative and qualitative assessment of PrEP or other HIV prevention use, decisional certainty, and satisfaction with information about HIV prevention options. Hypotheses: 1. Women who use the HIV prevention decision support tool will be more likely to have initiated PrEP within 3 months compared to women who received standard counseling at the time of their initial appointment. 2. The HIV prevention decision support tool will increase women's knowledge of PrEP and other HIV prevention methods compared to women who received standard counseling at the time of their initial appointment. 3. The HIV prevention decision support tool will increase participants' decisional certainty in their choice of an HIV prevention method compared to women who received standard counseling at the time of their initial appointment.

NCT ID: NCT04607408 Active, not recruiting - HIV Infections Clinical Trials

Evaluating Safety and Immune Response to the HIV-1 CH505 Transmitted/Founder gp120 Adjuvanted With GLA-SE in Healthy, HIV-exposed Uninfected Infants

HVTN 135
Start date: November 10, 2020
Phase: Phase 1
Study type: Interventional

This study will evaluate the safety and immune response in healthy HIV-exposed and uninfected infants to the protein vaccine, CH505TF gp120, adjuvanted with GLA-SE.