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NCT ID: NCT06031272 Not yet recruiting - HIV-1-infection Clinical Trials

Pausing Antiretroviral Treatment Under Structured Evaluation

PAUSE
Start date: May 15, 2024
Phase: Phase 1
Study type: Interventional

The main purpose of this study is to see if it is safe to give the study antibodies (3BNC117-LS-J and 10-1074-LS-J) by intravenous infusion to people with HIV (PWH), and to see if they cause any side effects. In addition, to see how the study antibodies affect the level of HIV in the blood when participants are not taking regular HIV treatment for an extended period. This extended period of not taking regular HIV treatment is called an analytical treatment interruption (ATI).

NCT ID: NCT05959707 Not yet recruiting - HIV Infections Clinical Trials

Evaluating the Safety, Tolerability, and Pharmacokinetics of Monoclonal Antibodies in Healthy Participants

HVTN143
Start date: April 14, 2024
Phase: Phase 1
Study type: Interventional

Part A: The purpose of this part is to study how the body's immune system reacts to a lab-made HIV-1 monoclonal antibody against HIV antigen when given in different doses. The study will also evaluate if the antibody is safe to give to people and does not make them too uncomfortable. Part B: The purpose of this part is to study how the body's immune system reacts to a combination of lab-made HIV-1 monoclonal antibodies against HIV antigens when given in different doses. The study also wants to see if the way the antibodies are given affects the immune response.

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: NCT05883657 Not yet recruiting - Solar Lentigo Clinical Trials

Tolerance and Performance of Cyto-selective Difluoroethane-based Cryotherapy in the Treatment of Brown Spots (Solar and Senile Lentigines, Post-Inflammatory Hyperpigmentation)

Start date: June 10, 2023
Phase: N/A
Study type: Interventional

CS5_7 study aim to evaluate the tolerance and to adjust the mode of administration of two conditions of cryotherapy treatment applied on the brown spots of the face and hands with 1 prototype (816-v1). A brown spot is defined as solar or senile lentigo and post-inflammatory hyperpigmentation (PIH). The study will evaluate the following prototype : • Prototypes from (816-v1 201) to (816-v1 290)

NCT ID: NCT05797662 Not yet recruiting - Kaposi Sarcoma Clinical Trials

A Study of Propranolol to Treat Kaposi Sarcoma

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

A clinical study of propranolol for the treatment of Kaposi Sarcoma in children and adults. This study will be an open-label single armed treatment trial that will test the effectiveness and the safety of treating Kaposi Sarcoma with propranolol.

NCT ID: NCT05766696 Not yet recruiting - Dental Caries Clinical Trials

Survival Rate and Cost-effectiveness of Conventional vs ART Restorations in a School Setting

Start date: May 2023
Phase: N/A
Study type: Interventional

This study will investigate the performance and cost-effectiveness of glass-ionomer restorations placed in school children in an outreach setting in rural areas in South Africa over a 2-year period, when placed using either ART (in a classroom) or conventional (in a mobile clinic) cavity preparation.

NCT ID: NCT05633056 Not yet recruiting - HIV Infections Clinical Trials

An Adaptive Randomized Controlled Trial

ADAP-TIV
Start date: February 2023
Phase: N/A
Study type: Interventional

This is a prospective, adaptive, randomized controlled trial comparing the effectiveness of 4 intervention arms on a combined endpoint in adults with confirmed MDR-TB HIV initiating Bedaquiline-containing MDR-TB treatment regimens and on ART (integrase strand transfer inhibitor (INSTI)-based fixed dose combination therapy) in KwaZulu-Natal, South Africa. Interventions arms include: enhanced standard of care; psychosocial support; mHealth using cellular-enabled electronic dose monitoring; combined mHealth psychosocial support. Level of support will be adjusted using a differentiated service delivery (DSD)- informed assessment of treatment support needs.

NCT ID: NCT05553236 Not yet recruiting - Clinical trials for Drug-resistant Tuberculosis

Pragmatic Use of Next-generation Sequencing for Management of Drug-resistant Tuberculosis

TSELiOT
Start date: February 28, 2024
Phase: N/A
Study type: Interventional

TS ELiOT is a stepped-wedge, cluster randomized trial assessing the effect of a next-generation sequencing-based strategy on rifampin-resistant tuberculosis management and patient outcomes.

NCT ID: NCT05539989 Not yet recruiting - HIV Infections Clinical Trials

Safety and Immunogenicity of VPM1002 Vaccination or BCG Revaccination Against TB in Pre-Adolescents Living With and Without HIV in South Africa

Start date: December 31, 2024
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to assess whether Mycobacterium bovis rBCGΔureC::hly (VPM1002) vaccination and Mycobacterium bovis bacille Calmette-Guérin (BCG) revaccination are safe and immunogenic in pre-adolescents with and without HIV and with and without Mycobacterium tuberculosis (M.tb) sensitization.

NCT ID: NCT05264662 Not yet recruiting - dTap Vaccine Clinical Trials

Pertussis Vaccination Among HIV-infected and HIV-uninfected Pregnant Women

Start date: March 2022
Phase: Phase 4
Study type: Interventional

Pertussis (also known as whooping cough) is a highly contagious, vaccine-preventable respiratory tract disease, caused by the bacteria Bordetella pertussis. It can affect people of all ages, however young unimmunised or partially immunised infants are the most vulnerable group with the highest rates of complications and death. Recent surveillance data and an increase in the number of pertussis outbreaks being reported nationally, indicate an increase in the incidence of pertussis disease in South Africa.To date there is no data on the effect of vaccinating HIV-infected pregnant women with pertussis-containing vaccines, although there is no reason to think that vaccinating these women would be harmful for them or their foetus. The knowledge gaps on the immunogenicity, safety and VE of pertussis vaccination of HIV-infected pregnant women should be addressed. Adacel which is a registered and licensed vaccine manufactured by Sanofi Pasteur, will be tested in this study.