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HIV Infections clinical trials

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NCT ID: NCT04927585 Completed - HIV Infections Clinical Trials

Evaluating the Safety and Immunogenicity of Polyvalent DNA/gp120 HIV Vaccine in Healthy, HIV-uninfected Adults

Start date: July 8, 2021
Phase: Phase 1
Study type: Interventional

The purpose of the study is to evaluate the safety, tolerability, and immunogenicity of polyvalent env (A,B,C,A/E)/gag (C) DNA and gp120 (A,B,C,A/E) protein vaccines (PDPHV201401) co-administered together with or without adjuvant in repeated doses in healthy, HIV-uninfected adults

NCT ID: NCT04916223 Completed - Stroke Clinical Trials

Study to Determine Therapeutic Massage Dosing to Improve Quality of Life in Hospitalized Patients Receiving Palliative Care

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

Therapeutic massage is the most common non-traditional treatment option offered to improve quality of life, provide comfort and decrease pain in hospice and palliative care settings outside the hospital. Three systematic reviews of data in general pain, surgical and cancer populations found massage to be effective for treating pain versus active comparators. Given the remarkable negative impact on QOL experienced by patients hospitalized with a serious progressive illness, a nationwide opioid crisis in the setting of public concern for untreated pain, and patient demand for integrative therapies, we wish to investigate non-traditional methods of supporting patients in pain and providing clinicians with viable alternatives. Unfortunately, very little is known about optimal delivery of massage interventions in the hospital setting, including dosing parameters such as time and frequency We conducted a single center comparative effectiveness study to evaluate therapeutic massage "dosing" to improve self-reported quality-of-life in hospitalized patients receiving palliative care consultation.

NCT ID: NCT04915469 Completed - HIV Infection Clinical Trials

Enhanced Adherence Counselling, Pre-Post Study

Start date: March 4, 2019
Phase: N/A
Study type: Interventional

Viral suppression among children and adolescents in Kenya is currently sub-optimal at 60% and 63% respectively. Under the current Kenya Ministry of Health Guidelines, clients with viral load of >1000 copies/ml, should receive a minimum of three enhanced adherence counselling (EAC) sessions offered every two weeks and have a repeat viral load conducted 3 months after EAC completion. However, delivery of the EAC is not standardized and there is limited data available to evaluate the effectiveness of the three counselling sessions. Observational data from Elizabeth Glaser Pediatric AIDS Foundation (EGPAF)-supported sites in Homa Bay and Turkana counties indicate that among children and adolescents with a viral load > 1000 copies/ml, approximately 40% received the recommended three minimum EAC sessions and, after receiving EAC sessions, viral suppression was 33% in children aged below 9 years, 27% in adolescents aged between 10-14 years, 38% in adolescents aged 15 to 19 years and 53% in adults. The investigators propose to evaluate the implementation, effectiveness and acceptability of a standardized EAC package implemented at EGPAF-supported sites. Methods: The investigators will use mixed methods to evaluate specific clinical outcomes (viral suppression) adherence, retention) among children and adolescents who receive the EAC package after suspected treatment failure, and if applicable, after switch to second and third line. The investigators will use a pre/post intervention assessment to evaluate the effectiveness of the EAC package, and qualitative methods (in-depth individual interviews (IDI) and focus group discussions (FGD)) to identify facilitators and barriers to accessing EAC. A process evaluation will be conducted to determine whether the standardized EAC package has been implemented as intended across sites. The study population is defined as children aged 0-19 years receiving Antiretroviral therapy (ART) in selected EGPAF supported sites. Policy Significance: Dissemination of findings will be done through: internal evaluation report shared with stakeholders, donors, and the Ministry of Health (MOH) and abstracts presented at local and international conferences; and, manuscripts for publication in peer-reviewed journals. Findings are expected to inform the continuous review and improvement of HIV Program delivery in Kenya, as the ministry of health and partners strive to meet international standards.

NCT ID: NCT04904406 Completed - HIV Infections Clinical Trials

Changes in Weight, Body Composition and Cardiac Risk After Discontinuing Abacavir Treatment in HIV-infected Individuals

AVERTAS
Start date: October 22, 2020
Phase: Phase 4
Study type: Interventional

Randomized controlled parallel open-label study in people living with HIV and at least 6 month of treatment with dolutegravir/abacavir/lamivudine prior to inclusion. Participants (n=95) are randomized to continue 3 drug-regimen dolutegravir/abacavir/lamivudine (control) or switch to two-drug regimen with dolutegravir/lamivudine (intervention). Follow-up is 48 weeks. Data is collected at baseline and week 48. Primary outcome is changes in weight from baseline of more than 2 kg. Secondary outcomes are changes in cardiac risk, composition and calcification of the heart tissue, and changes in body composition and metabolism, inflammation and coagulation. A MRI substudy is applied to focus on the cardiac adverse effects of abacavir.

NCT ID: NCT04896216 Completed - HIV Infections Clinical Trials

Standardized Patients to Measure and Address Intersectional Stigma

Start date: November 24, 2020
Phase: N/A
Study type: Interventional

This study aims to develop and evaluate an intervention to reduce enacted stigma in healthcare settings aimed at people living with HIV (PLWH) and men who have sex with men (MSM) in China. Enacted stigma will be measured using a quality of care score collected through unannounced standardized patient (SP) visits to consenting providers in sexual health clinics.

NCT ID: NCT04880785 Completed - HIV Infections Clinical Trials

Lamivudine/Dolutegravir in Virologically Suppressed Subjects With Expected or Confirmed Resistance to Lamivudine

VOLVER
Start date: July 28, 2021
Phase: Phase 2
Study type: Interventional

Dolutegravir (DTG) plus lamivudine (3TC) is a dual regimen combination recommended for both naïve and suppressed persons with HIV-1 infection1. However, data regarding the efficacy of this regimen in suppressed persons with history of past resistance or virologic failures is currently insufficient. This is a phase IIa, open-label, single arm, multicentric study. The hypothesis is that therapy with DTG/3TC would be able to maintain viral control in HIV infected participants with prior history of 3TC resistance but without evidence of M184V/I resistance mutation in proviral DNA population sequencing at baseline. The investigators also hypothesize that archived minority 3TC resistance associated mutations detected by next-generation (NGS) sequencing prior to the switch would not have a significant impact on the efficacy of DTG/3TC.

NCT ID: NCT04871113 Completed - HIV Infections Clinical Trials

A Study to Evaluate the Antiviral Effect, Safety and Tolerability of GSK3810109A in Viremic Human Immunodeficiency Virus (HIV)-1 Infected Adults

Start date: June 22, 2021
Phase: Phase 2
Study type: Interventional

This study is to evaluate antiviral activity, efficacy, safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of GSK3810109A in HIV-1 infected treatment naive adults. Participants will receive a single dose of GSK3810109A administered either intravenously (IV) or subcutaneously (SC). The study includes a screening phase, a randomized monotherapy phase and a standard of care follow-up phase.

NCT ID: NCT04870671 Completed - HIV/AIDS Clinical Trials

Project ADHERE: Clinical Proof-of-Concept of a Tenofovir (TFV) Aptamer-Based Biosensor

Start date: March 25, 2021
Phase: Early Phase 1
Study type: Interventional

Truvada®, an oral pill comprised of two anti-retroviral compounds, emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF), is currently the only drug combination approved for pre-exposure prophylaxis (PrEP) in women exposed to high HIV risk through vaginal acquisition. Adherence to the one pill per day regimen is crucial for its effectiveness in reducing the risk of acquiring HIV. Currently, there is no available point of care diagnostic test to quickly measure blood levels of tenofovir in the clinic. This study will determine whether a tenofovir (TFV) aptamer-based biosensor (aptasensor) can detect TFV in biological fluids from women randomized to different dosing regimens representing high and low adherence.

NCT ID: NCT04863261 Completed - HIV Infections Clinical Trials

Cabenuva Injection Tracking in CHORUS

Start date: October 1, 2021
Phase: N/A
Study type: Interventional

This is a cluster randomized trial in which clinics will be randomized to the intervention or the control arm. The purpose of this study is to assess if receiving alerts can help providers manage the scheduling of monthly cabotegravir + rilpivirine long-acting injections for the treatment of HIV.

NCT ID: NCT04857892 Completed - HIV Infections Clinical Trials

A Relative Bioavailability and Food-Effect Study of the Fixed Dose Combination of GSK3640254 and Dolutegravir (DTG) in Healthy Participants

Start date: April 21, 2021
Phase: Phase 1
Study type: Interventional

This is a two part study to compare the relative bioavailability (BA) of 2 fixed dose combinations (FDCs) of GSK3640254/DTG with GSK3640254 and DTG administered together as single agents (Part 1) and to assess the effect of food on the pharmacokinetic (PK) of the selected FDC of GSK3640254/DTG (Part 2).