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HIV Infections clinical trials

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NCT ID: NCT04669678 Active, not recruiting - HIV Infections Clinical Trials

Evaluation of Pharmacokinetic Drug-drug Interactions Between Hormonal Contraceptives and Doravirine-containing ART Among Women Living With HIV in South Africa

EPIC
Start date: November 17, 2021
Phase: Phase 4
Study type: Interventional

The study investigators are conducting an observational, parallel group pharmacokinetic (PK) study among women living with HIV (WLHIV) already on 1st line antiretroviral therapy (ART) and virally suppressed, 18-45 years old (inclusive), to evaluate any bidirectional drug-drug interactions (DDIs) between doravirine (DOR)-containing ART and hormonal contraceptive methods. This PK study will enroll women in five distinct groups, each with 21 participants (total of 105 participants), and follow them for approximately 18-30 weeks.

NCT ID: NCT04652804 Active, not recruiting - Hepatitis C Clinical Trials

Supporting Treatment Outcomes Among PWID

STOP-C
Start date: January 21, 2021
Phase: N/A
Study type: Interventional

The goal of this study is to improve HCV care continuum outcomes for people who inject drugs (PWID), reduce potential onward transmission to others and improve HIV outcomes among those who are HIV/HCV coinfected. The study will evaluate whether HCV treatment outcomes (sustained virologic response, treatment completion, adherence) and post treatment outcomes (HCV reinfection, HIV viral suppression) in HCV mono- and HIV/HCV co-infected PWID can be optimized by tailoring treatment support in 7 PWID-focused integrated HIV/HCV prevention and treatment centers in India.

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: 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.

NCT ID: NCT04562649 Active, not recruiting - HIV/AIDS Clinical Trials

Community Health Worker And MHealth to ImProve Viral Suppression

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

The overall goal of this study is to evaluate the effects of the CHAMPS intervention for people living with HIV (PLWH) in a randomized controlled trial. The proposed trial is scientifically significant in representing a principled and systematic effort to test the efficacy of a combined community health worker (CHW) and smartphone intervention linked to a smart pill box for antiretroviral (ART) adherence in PLWH in the United States (US). Guided by a rigorous theoretical model of supportive accountability and building on preliminary work, this intervention has the potential to enable PLWH to self-manage their ART regimens while CHW monitor their ART adherence in real-time ultimately leading to viral suppression and ART adherence.

NCT ID: NCT04530630 Active, not recruiting - HIV Infections Clinical Trials

Switch to Bictegravir/Emtricitabine/Tenofovir Alafenamide After Renal Transplant

Start date: November 9, 2020
Phase: Phase 4
Study type: Interventional

This is an open-label study, where participants will be switched from their current HIV medication to the study drug, Biktarvy. Open-label means both the investigator and the participant will know what drug will be given. Participants will be followed for 48 weeks in order to monitor the efficacy, safety and tolerability of Biktarvy. The investigator hypothesizes that Biktarvy will be an important addition to the management of HIV-positive post renal transplant patients, especially since it is a one pill daily dosing regimen, thereby decreasing the pill burden in this population.

NCT ID: NCT04527874 Active, not recruiting - HIV Infections Clinical Trials

Viral Load Triggered ART Care in Lesotho

VITAL
Start date: October 14, 2020
Phase: N/A
Study type: Interventional

This cluster randomized clinical trial at 18 nurse-led rural health centers in Lesotho will test an automated differentiated service delivery model using viral load results, other clinical characteristics and participants' preference to automatically triage participants into groups requiring different levels of attention and care.

NCT ID: NCT04515225 Active, not recruiting - HIV Infections Clinical Trials

COVID-19 Prevalence in HIV-infected Patients

SeCoVIHA
Start date: November 4, 2020
Phase:
Study type: Observational

North-east area of France was hit in February 2020 by the new coronavirus disease, more severely than other French regions. Factors affecting the evolution of the disease and its severity have been quickly identified, among them figuring different kinds of immune deficiency. Even if nowadays HIV infection is usually well controlled by ARV drugs, those patients with uncontrolled viral load and/or low CD4 cell counts, remain at higher risk of severe COVID infection. In this context, the primary objective of our study is aimed at evaluating the prevalence of SARS-CoV-2 antibodies in a cohort of HIV-infected patients followed-up in an HIV-infection care center. Secondary objectives are: evaluating whether the antibodies are protective or not, the kinetic of these antibodies, and HIV associated factors with the presence of antibodies.

NCT ID: NCT04514484 Active, not recruiting - HIV Infection Clinical Trials

Testing the Combination of the Anti-cancer Drugs XL184 (Cabozantinib) and Nivolumab in Patients With Advanced Cancer and HIV

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

This phase I trial investigates the side effects of cabozantinib and nivolumab in treating patients with cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) and who are undergoing treatment for human immunodeficiency virus (HIV). Cabozantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving cabozantinib and nivolumab may shrink or stabilize cancer in patients undergoing treatment for HIV.