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HIV-1 Infection clinical trials

View clinical trials related to HIV-1 Infection.

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NCT ID: NCT05136703 Recruiting - Depression Clinical Trials

Treatment Research Investigating Depression Effects on Neuroimmune Targets (TRIDENT)

TRIDENT
Start date: August 30, 2022
Phase: N/A
Study type: Interventional

The purpose of this randomized controlled trial is to understand how a cognitive-behavioral treatment (a form of psychological treatment) for depression changes the gut microbiome (micro-organisms that regulate the health of the gut), immune system, and the brain functioning in people living with HIV.

NCT ID: NCT05129345 Recruiting - Hypertension Clinical Trials

Addressing Barriers to Achieving Cardiometabolic Disorders Prevention and Treatment Goals for PLWH in the SE US

Start date: June 7, 2022
Phase:
Study type: Observational

This study has 3 aims. Aim 1: Identify social determinants of cardiometabolic health and determine facilitators and modifiable barriers in achieving treatment goals. Aim 2: Assess PLWH knowledge, skills, and confidence for self-management of cardiometabolic disorders. Aim 3: Tailor a self-management support and education intervention with stakeholder input to address barriers to achieving treatment goals for cardiometabolic disorders in PLWH at the study sites.

NCT ID: NCT05051163 Recruiting - HIV-1-infection Clinical Trials

Strategies to Reduce Mortality Among HIV-infected and HIV-exposed Children Admitted With Severe Acute Malnutrition

REDMOTHIV
Start date: June 14, 2021
Phase: Phase 2/Phase 3
Study type: Interventional

This study to investigate whether empiric use of an antibiotic with greater antimicrobial sensitivity (ceftriaxone) than standard-of-care (ampicillin plus gentamicin) will reduce mortality among HIV-infected/HEU children admitted to Mwanamugimu Nutrition Unit, Mulago Hospital, Kampala, Uganda.

NCT ID: NCT04979468 Recruiting - HIV-1-infection Clinical Trials

Early DOlutegravir/LAmivudine Switching After Virological Suppression (EDOLAS Study)

EDOLAS
Start date: March 23, 2021
Phase: Phase 3
Study type: Interventional

Phase III, randomized, open-label, multicentre, active-controlled, non-inferiority study evaluating the efficacy and safety of early switching to dolutegravir/lamivudine (DTG/3TC) in single-pill, in HIV-1 infected individuals currently taking an INSTI-based three-drug first-line regimen for less than 18 months and who have been virologically suppressed with HIV-1 RNA <50 copies/mL

NCT ID: NCT04950530 Recruiting - HIV-1-infection Clinical Trials

The Effect of Biktarvy (B/F/TAF) on Whole-body Insulin Sensitivity, Lipid and Endocrine Profile in Healthy Volunteers

Start date: December 22, 2022
Phase: Phase 1
Study type: Interventional

This study will investigate changes in insulin sensitivity, lipid metabolism and endocrine profile in HIV-negative subjects exposed to Biktarvy (B/F/TAF) compared to subject not exposed to B/F/TAF for 28 days.

NCT ID: NCT04938518 Recruiting - HIV-1-infection Clinical Trials

Latent HIV-1, Viral Suppress and Hope for HIV Cure

Start date: May 1, 2019
Phase:
Study type: Observational [Patient Registry]

In 2014, the Joint United Nations Program on HIV/AIDS (UNAIDS) issued treatment goals for Human Immunodeficiency Virus (HIV), the 90-90-90 target. It is important to track success results at each stage of the HIV continuum of care to evaluate progress towards the 90-90-90 target. Although ART can suppress HIV-1 infection to undetectable levels of plasma viremia, HIV DNA integrate and persist in resting CD4+ T cells. Most of the HIV DNA in these cells is defective and cannot cause infection. However, latent HIV-1 genomes that encode replication-competent virus can resurface once ART is discontinued. This latent reservoir is believed to be the largest impediment to a cure by ART alone. There is need for expansion of research examining HIV latency in the context of sustained viral suppression with an eye towards developing a possible cure regimen that could be used on a large scale. To date, there have been no systematic studies to quantify the latent reservoir in virally suppressed HIV-infected patients in Africa. Detecting how much of the inducible virus is left in the human body after ART poses the greatest challenge to fully curing HIV. This study is designed to enroll 222 virally suppressed HIV infected men and women, who will be prospectively followed to document antiviral cocktail, viral suppression and incidences of rebound, measure the size of the latent HIV reservoir and examine the immunological correlates of the latent reservoir. Data generated through this study will provide a clear framework for high-burden countries to reduce gaps at each stage of the HIV continuum of care, maximize linkage, retention and health outcomes.

NCT ID: NCT04892654 Recruiting - HIV-1-infection Clinical Trials

Efficacy of Doravirine + Dolutegravir Dual Therapy in the Context of Antiretroviral Therapy Switch

DORDOL
Start date: August 17, 2022
Phase: Phase 3
Study type: Interventional

Combination antiretroviral therapy (cART) HIV treatments are associated with increased quality of life, and a normalisation of life expectancy in people living with HIV. However, long-term use of cART can lead to side-effects through exposure to drug-related toxicity. For this reason researchers are interested in looking at alternative therapies that might expose patients to fewer and less severe side effects while providing the same quality of care as antiretroviral therapies most often used to treat HIV. The purpose of this study is to investigate if the study drug combination that is being tested (doravirine + dolutegravir) is safe compared with other triple cART regimens.

NCT ID: NCT04883255 Recruiting - HIV-1-infection Clinical Trials

Cannabis Use, Cognition, and the Endocannabinoid System in HIV

Start date: May 3, 2023
Phase: Early Phase 1
Study type: Interventional

Understanding how co-morbidities in persons with HIV (PWH) such as substance use affect risk-taking, decision-making, and other cognitive behaviors is important given implications for everyday functioning and transmission risk. The high prevalence of cannabis use in PWH, medicinally and recreationally, may indicate disease severity, impart therapeutic benefits, or adverse consequences. In fact, cannabis is recommended to those with HIV to alleviate nausea, improve appetite, relieve pain, and lift mood. To-date, the consequences of cannabis use in PWH remain unclear as do potential interactions with HIV treatments. In healthy participants, heavy cannabis use is associated with cognitive deficits e.g., risky decision-making, response disinhibition and inattention, but pro-cognitive effects in PWH may exist at mild use levels due to its anti-inflammatory and anti-excitotoxic properties. Furthermore, little has been done to determine the effects of cannabis use on the endocannabinoid (EC) system in general or in PWH. This study will determine the effects of the two primary cannabis constituents (Δ9-tetrahydrocannabinol [THC], cannabidiol [CBD]) vs. placebo on risky decision-making, response inhibition, reward learning, temporal perception, and motivation, plus EC and homovanillic acid (HVA; a surrogate for dopamine activity) levels in HIV+ and HIV- subjects. Participants with infrequent cannabis use will undergo baseline cognitive testing and biomarker assays with antiretrovirals (ART) use quantified. They will be randomized to a 5-day course of either THC, CBD, or placebo and return for follow-up testing and re-assaying of ECs and HVA levels.

NCT ID: NCT04880395 Recruiting - HIV-1-infection Clinical Trials

Dolutegravir-Lamivudine for naïve HIV-Infected Patients With ≤200 CD4/mm3

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

Protocol Title: DOLCE: Dolutegravir-Lamivudine for naïve HIV-Infected Patients with ≤200 CD4/mm3 Protocol Number: FH-57 Study Objectives: To assess the antiviral activity at week 48 of DTG+3TC among naïve HIV patients with a CD4 count ≤200 cells /mm3.

NCT ID: NCT04738812 Recruiting - Tuberculosis Clinical Trials

Determination of Adequate Tuberculosis Regimen in Patients Hospitalized With HIV-associated Severe Immune Suppression

DATURA
Start date: April 21, 2022
Phase: Phase 3
Study type: Interventional

DATURA trial is a phase III, multicenter, two-arm, open-label, randomized superiority trial to compare the efficacy and the safety of an intensified tuberculosis (TB) regimen versus standard TB treatment in HIV-infected adults and adolescents hospitalized for TB with CD4 ≤ 100 cells/μL over 48 weeks: - Intensified TB treatment regimen: increased doses of rifampicin and isoniazid together with standard-dose of pyrazinamide and ethambutol for 8 weeks in addition to prednisone for 6 weeks and albendazole for 3 days - WHO standard TB treatment regimen. The continuation phase of TB treatment will be identical in the two arms: 4 months of rifampicin and isoniazid at standard doses.