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HIV-1 Infection clinical trials

View clinical trials related to HIV-1 Infection.

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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: NCT04860063 Not yet recruiting - Metabolic Syndrome Clinical Trials

Effect of Berberine on Metabolic Syndrome, Efficacy and Safety in Combination With Antiretroviral Therapy in PLWH.

BERMESyH
Start date: April 2021
Phase: Phase 3
Study type: Interventional

With current antiretroviral therapy, people living with HIV reach virological suppression faster, which in turn leads to a higher life expectancy. Nevertheless, this improved survival rate is not free of other comorbidities, such as metabolic syndrome, characterized by a decrease in glucose tolerance and an increase in insulin resistance. Berberine is an alkaloid that has proven beneficial effects on both glucose tolerance and insulin resistance, but has not been tested in people living with HIV under virological suppression. We hypothesize that berberine will improve inflammatory markers and metabolic profile in this population without significant interactions nor adverse effects.

NCT ID: NCT04811040 Completed - HIV-1 Infection Clinical Trials

Study to Evaluate the Safety and Efficacy of Teropavimab and Zinlirvimab in Combination With Lenacapavir (GS-6207) in Virologically Suppressed Adults With HIV-1 Infection

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

The primary objective of this study is to evaluate the safety and tolerability of a combination of the broadly neutralizing antibodies (bNAbs) teropavimab (formerly GS-5423) and zinlirvimab (formerly GS-2872) in combination with the HIV capsid inhibitor lenacapavir (LEN).

NCT ID: NCT04802811 Completed - HIV-1 Infection Clinical Trials

A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics ,Pharmacodynamics of Oral SHR2150 in Healthy Subjects

Start date: March 22, 2021
Phase: Phase 1
Study type: Interventional

The study is a randomized, Double-Blind, Placebo-Controlled study to evaluate the safety, tolerability and pharmacokinetics, pharmacodynamics of SHR2150. will consist of 50 healthy subjects, 5 groups. The purpose of this part is to explore the safety, tolerability ,pharmacokinetics and pharmacodynamics of single doses of SHR2150 capsule in healthy subjects.

NCT ID: NCT04776252 Active, not recruiting - HIV-1 Infection Clinical Trials

Open-label, Follow-up of Doravirine/Islatravir (DOR/ISL 100 mg/0.75mg) for Participants With Human Immunodeficiency Virus-1 (HIV-1) Infection (MK-8591A-033)

Start date: September 15, 2021
Phase: Phase 3
Study type: Interventional

The safety and tolerability of MK-8591A, a 2-drug fixed dose combination (FDC) of doravirine (DOR 100mg) and islatravir (ISL 0.75mg) will be evaluated in participants with Human Immunodeficiency Virus -1 (HIV-1) who were treated with DOR and ISL in earlier clinical studies.

NCT ID: NCT04770701 Completed - HIV-1-infection Clinical Trials

Protect and Improve Cluster of Differentiation 4 (CD4) Cells and B Cells Lymphocytes

Start date: December 2015
Phase: Phase 4
Study type: Interventional

This is a plant-based medication used to increase the amount, protect, and reduce HIV's impact on T and B lymphocytes.

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.

NCT ID: NCT04718974 Completed - HIV-1-infection Clinical Trials

Call for Life Youth ART Adherence Study

C4L-Youth
Start date: August 12, 2020
Phase: N/A
Study type: Interventional

Study purpose: To assess effect of mHealth Call for life Uganda tool (CFLU) on ART adherence among youth measured by interactive voice response to daily adherence calls mapped in the database and proportion with viral suppression of copies below 1000 copies/mL. The intervention call for life Uganda (CFLU) uses IVR calls or text messages delivered via MOTECH™ based Connect for Life technology™. The calls are delivered in 4 languages (Luganda, English, Luo and Runyakitara) and the participant has to make a choice of the preferred language during registration to the system. The system offers adherence pill reminders, health message tips, visit appointment reminders and receipt of self-reported symptoms.

NCT ID: NCT04711265 Completed - HIV-1-infection Clinical Trials

Antibody Response to Prophylactic QHPV Vaccine at 48 Months Among HIV-infected Girls and Boys

Start date: September 2015
Phase:
Study type: Observational

Longitudinal observational cohort study and extension of the MISP ID: 38406 'immunogenicity and safety of quadrivalent human papillomavirus vaccine in HIV-infected pre-adolescent girls and boys in Kenya'.