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NCT ID: NCT05937698 Recruiting - HIV Prevention Clinical Trials

The CATALYST Study

Start date: May 30, 2023
Phase:
Study type: Observational

The CATALYST study is an implementation study that will characterize and assess the implementation of an enhanced service delivery package providing informed choice of pre-exposure prophylaxis (PrEP) products among women at PEPFAR sites in Kenya, Lesotho, South Africa, Uganda, and Zimbabwe.

NCT ID: NCT05933577 Recruiting - Melanoma Clinical Trials

A Clinical Study of V940 Plus Pembrolizumab in People With High-Risk Melanoma (V940-001)

Start date: July 19, 2023
Phase: Phase 3
Study type: Interventional

The purpose of this study is to learn if V940 which is an individualized neoantigen therapy (INT; formerly, called messenger ribonucleic acid [mRNA]-4157) with pembrolizumab (MK-3475) is safe and prevents cancer from returning in people with high-risk melanoma. Researchers want to know if V940 with pembrolizumab is better than receiving pembrolizumab alone at preventing the cancer from returning.

NCT ID: NCT05933226 Recruiting - Clinical trials for Human Immunodeficiency Virus

Project Khanya: Peer-Delivered Intervention to Improve HIV Medication Adherence and Substance Use in South Africa

Start date: June 21, 2023
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate a stepped care behavioral intervention for HIV medication adherence and substance use ("Khanya") integrated into an HIV primary care setting in South Africa. The intervention is specifically designed to be implemented by non-specialist counselors with lived substance use experience (i.e., peers), using a task sharing, stepped care model in local primary care clinics. The Khanya stepped care package will be compared to usual care, enhanced with referral to a local outpatient substance use treatment program (Enhanced Standard of Care - ESOC) over 12 months.

NCT ID: NCT05926466 Recruiting - Clinical trials for Tuberculosis, Pulmonary

BTZ-043 Dose Evaluation in Combination and Selection

DECISION
Start date: September 21, 2023
Phase: Phase 2
Study type: Interventional

This is a phase 2B, open label study, that will compare the safety and efficacy of three experimental regimens consisting of bedaquiline and delamanid in combination with different doses of BTZ-043, a novel antibiotic, in adult participants with newly diagnosed, drug-sensitive pulmonary tuberculosis. Participants will be assigned to receive either one of the three BTZ-043-containing regimens or a comparator regimen consisting of bedaquiline, delamanid and moxifloxacin. The objective is to find the optimal dose of BTZ-043 with the highest efficacy and safety to be used in subsequent studies.

NCT ID: NCT05925803 Recruiting - Systemic Sclerosis Clinical Trials

Determine Effectiveness of Anifrolumab In SYstemic Sclerosis (DAISY)

DAISY
Start date: November 8, 2023
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of treatment with subcutaneous anifrolumab versus placebo in adult participants with systemic sclerosis. The target population for this study includes patients who meet the 2013 American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) classification for systemic sclerosis, either limited or diffuse cutaneous subsets, with a disease duration of less than 6 years from first non-Raynaud's phenomenon symptom.

NCT ID: NCT05924438 Recruiting - HIV-1-infection Clinical Trials

A Randomised, Phase 3 Non-inferiority Study of DOR/3TC/TDF Compared to DTG/TAF/FTC in Participants Infected With HIV-1 Starting First-line Antiretroviral Therapy

Opti-DOR
Start date: November 8, 2023
Phase: Phase 3
Study type: Interventional

This is an open label, randomised, phase 3, two-arm study conducted over 96 weeks. The study includes a screening period day - 60 to -1, enrolment visit day 0, and a 96-week treatment follow-up period. Approximately 600 male and female participants infected with HIV-1 eligible for first-line therapy, will be randomly assigned in a 1:1 ratio approximately 300 participants per treatment group to either Treatment Group 1 DOR/3TC/TDF or Treatment Group 2 DTG/TAF/FTC. All medications will be administered in an open label design.

NCT ID: NCT05923333 Recruiting - Hiv Clinical Trials

B. Infantis Supplementation to Improve Immunity in Infants Exposed to HIV

BifIID
Start date: August 11, 2023
Phase: N/A
Study type: Interventional

The primary objectives of this study are to evaluate the effect of early-life B. infantis Rosell®-33 supplementation in infants exposed to HIV on: - gut microbiome composition and diversity at 4 weeks of life - markers of intestinal inflammation and microbial translocation at 4 weeks of life - Th1 cytokine responses to BCG at 7 weeks and 36 weeks of life The secondary objectives include to evaluate the effect of B. infantis Rosell®-33 supplementation on: - longitudinal succession of the gut microbiota composition, diversity and function - relative and absolute abundance of B. infantis in infant stool during the first 36 weeks of life - stool metabolome - T cell subset ontogeny during the first 9 months of life. Exploratory objectives are to evaluate whether B. infantis Rosell®-33 supplementation improves: - infant growth - all-cause morbidity - neurodevelopment during the first 9 months of life - antibody responses to early childhood vaccines

NCT ID: NCT05919901 Not yet recruiting - HPV Clinical Trials

Multi-level School-based Intervention to Improve HPV Vaccine Uptake and Completion in South Africa

Start date: January 1, 2025
Phase: Phase 2
Study type: Interventional

Human Papillomavirus (HPV) is the most common sexually transmitted infection globally, and is causally linked to cervical, anogenital, and oropharyngeal cancers. HPV-associated cancers have a disproportionate impact in low-resource settings and nowhere is this evident than in South Africa, which has a uniquely vulnerable population due to the convergence of the largest HIV epidemic globally, with HPV rates of up to 85% in young women under the age of 25. For the clinical trial phase of this study, we intend to evaluate preliminary effects of a communications strategy and key criteria to advance to a full scale hybrid type 2 trial. Our systems-focused approach leverages established partnerships with area schools serving diverse populations who are not always effectively served by traditional healthcare channels.

NCT ID: NCT05912283 Completed - Clinical trials for Sexually Transmitted Diseases

Evaluation of 2 Synthetic Nitrile Male Condoms Compared to a Standard Latex Male Condom

Start date: June 2, 2023
Phase: N/A
Study type: Interventional

This is a multi-site, randomised 3-period cross-over trial evaluating the functional performance of two synthetic nitrile male condoms against a control latex male condom.

NCT ID: NCT05909995 Recruiting - Melanoma Clinical Trials

Interventional Study of INCB 99280 With Ipilimumab in Participants With Select Solid Tumors

Start date: August 29, 2023
Phase: Phase 1
Study type: Interventional

The purpose of this study is to characterize the safety, tolerability, PK, and efficacy of INCB 99280 in combination with ipilimumab in participants with select solid tumors.