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NCT ID: NCT04166474 Active, not recruiting - Hiv Clinical Trials

Drug Interactions Between Dolutegravir and Escalating Doses of Rifampicin

DoRIS
Start date: November 18, 2021
Phase: Phase 4
Study type: Interventional

This is a drug interaction study in HIV negative, TB-monoinfected participants coming to the end of continuation phase of TB therapy, to study the pharmacokinetic changes to dolutegravir when administered with standard, medium and high dose rifampicin.

NCT ID: NCT04158648 Active, not recruiting - Hemophilia A Clinical Trials

A Study to Evaluate the Safety, Efficacy, Pharmacokinetics and Pharmacodynamics of Emicizumab in Participants With Mild or Moderate Hemophilia A Without FVIII Inhibitors

HAVEN 6
Start date: February 10, 2020
Phase: Phase 3
Study type: Interventional

This is a multicenter, open-label, single-arm study designed to evaluate the safety, efficacy, pharmacokinetics, and pharmacodynamics of emicizumab in participants with mild or moderate hemophilia A without inhibitors against factor VIII (FVIII).

NCT ID: NCT04152161 Active, not recruiting - Tuberculosis Clinical Trials

Bacille Calmette Guerin (BCG) Revaccination of Healthy Adolescents for the Prevention of Mycobacterium Tuberculosis Sustained Infection

Start date: October 16, 2019
Phase: Phase 2
Study type: Interventional

The purpose of this study is to demonstrate the efficacy of Bacille Calmette Guerin (BCG) revaccination against sustained Mycobacterium tuberculosis infection versus placebo in previously BCG vaccinated QuantiFERON®-TB Gold Plus Assay (QFT) negative, healthy adolescents.

NCT ID: NCT04150068 Active, not recruiting - HIV-1-infection Clinical Trials

Study to Evaluate the Safety and Efficacy of Lenacapavir (GS-6207) in Combination With an Optimized Background Regimen (OBR) in Heavily Treatment Experienced Participants Living With HIV-1 Infection With Multidrug Resistance

CAPELLA
Start date: November 21, 2019
Phase: Phase 2/Phase 3
Study type: Interventional

The primary objective of this study is to evaluate the antiviral activity of lenacapavir (formerly GS-6207) administered as an add-on to a failing regimen (functional monotherapy) in people living with HIV (PLWH) with multi-drug resistance (MDR).

NCT ID: NCT04131465 Active, not recruiting - HIV Infections Clinical Trials

Home HIV Testing for Older Adults in South Africa

Test@Home
Start date: May 15, 2019
Phase: N/A
Study type: Interventional

Many older adults in rural South Africa still lack knowledge of their HIV status despite a high probability of infection. Older adults tend to test less for HIV because most HIV testing and prevention programs have been targeted at younger age groups. Other reasons for failure to test for HIV include frailty and lack of financial resources to travel to HIV testing centers. Home-based testing is a powerful approach to bring HIV testing services -- and HIV status knowledge -- to older adults. In real-life health systems, community health workers, such as the South African community care givers, could potentially provide home-based HIV testing on a routine basis. In this study, the investigators are trying to establish the best 'form' for the 'function' home-based HIV testing. Specifically, the investigators aim to 1. Establish the comparative effectiveness of three home-based HIV testing options among older adults in rural South Africa 2. Identify spill-over effects of the different home-based HIV testing options to other adults in the households and communities of the older adults receiving the testing options 3. Determine the comparative cost-effectiveness of the three home-based HIV testing options among older adults.

NCT ID: NCT04123366 Active, not recruiting - Solid Tumors Clinical Trials

Study of Olaparib (MK-7339) in Combination With Pembrolizumab (MK-3475) in the Treatment of Homologous Recombination Repair Mutation (HRRm) and/or Homologous Recombination Deficiency (HRD)-Positive Advanced Cancer (MK-7339-007/KEYLYNK-007)

Start date: November 18, 2019
Phase: Phase 2
Study type: Interventional

The purpose of this study is to assess the efficacy and safety of treatment with olaparib (MK-7339) in combination with pembrolizumab (MK-3475) in adults with previously treated, advanced (metastatic and/or unresectable) Homologous Recombination Repair Mutation (HRRm) and/or Homologous Recombination Deficiency (HRD)-positive solid tumors.

NCT ID: NCT04083781 Active, not recruiting - Clinical trials for Haemophilia A With Inhibitors

Research Study to Look at How Well the Drug Concizumab Works in Your Body if You Have Haemophilia With Inhibitors

explorer7
Start date: October 21, 2019
Phase: Phase 3
Study type: Interventional

This study will test how well a new medicine called concizumab works in the body of people with haemophilia A or B with inhibitors. The purpose is to show that concizumab can prevent bleeds in the body and is safe to use. Participants who usually only take medicine to treat bleeds (on-demand) will be placed in one of two groups. In one group, participants will get study medicine from the start of the study. In the other group, participants will continue with their normal medicine and get study medicine after 6 months. Which treatment the participant gets is decided by chance. Participants who usually take medicine to prevent bleeds (prophylaxis treatment) or who are already being treated with concizumab (study medicine) will receive the study medicine from the start of the study. Participants will get 1 injection with the study medicine every day under the skin. This participants will have to do themselves and can be done at home. The study doctor will hand out the medicine in the form of a pen-injector. The pen-injector will contain the study medicine. The study will last for about six years. The length of time the participants will be in the study depends on when they agreed to take part or when the medicine is available for purchase in their country (12 November 2025 at the latest). Participants will have to come to the clinic for up to 41 times. The time between visits will be approximately 4 weeks for the first 6 to 12 months, depending on the group participants are in and approximately 8 weeks for the rest of the study. Participants will be asked to record information into an electronic diary during the study and may also be asked to wear an activity tracker.

NCT ID: NCT04082429 Active, not recruiting - Clinical trials for Haemophilia B Without Inhibitors

Research Study to Look at How Well the Drug Concizumab Works in Your Body if You Have Haemophilia Without Inhibitors

explorer8
Start date: November 13, 2019
Phase: Phase 3
Study type: Interventional

This study will test how well a new medicine called concizumab works in the body of people with haemophilia A or B without inhibitors. The purpose is to show that concizumab can prevent bleeds in the body and is safe to use. Participants who usually only take medicine to treat bleeds (on-demand) will be placed in one of two groups. In one group participants will get study medicine from the start of the study. In the other group participants will continue with their normal medicine and get study medicine after 6 months. Which treatment the participant gets is decided by chance. Participants who usually take medicine to prevent bleeds (prophylaxis treatment) or who are already being treated with concizumab (study medicine) will receive the study medicine from the start of the study. Participants will have to inject themselves with the study medicine 1 time every day under the skin. This can be done at home. The study doctor will hand out the medicine in the form of a pen-injector. The pen-injector will contain the study medicine. The study will last for up to 6.5 years. The length of time the participant will be in the study depends on when they agreed to take part or when the medicine is available for purchase in their country (21 April 2026 at the latest). Participants will have to come to the clinic for up to 40 times. The time between visits will be approximately 4 weeks for the first 6 to 12 months depending on the group participants are in, and approximately 8 weeks for the rest of the study. If the participant attends extra visits due to the prescription medicine not being available for purchase in their country, these will be 14 weeks apart. Participants will be asked to record information in an electronic diary during the study and may also be asked to wear an activity tracker.

NCT ID: NCT04081077 Active, not recruiting - Clinical trials for Pulmonary Tuberculosis

PRACTECAL-PKPD Sub Study

PRACTECAL-PKPD
Start date: August 6, 2019
Phase: Phase 2/Phase 3
Study type: Interventional

PRACTECAL-PKPD is an exploratory pharmacokinetic and pharmacodynamic sub-study investigating the relationship between the patients' exposure to anti- tuberculosis (TB) drugs in the TB-PRACTECAL trial investigational regimens and their respective treatment outcomes.

NCT ID: NCT04062201 Active, not recruiting - Tuberculosis Clinical Trials

Building Evidence for Advancing New Treatment for Rifampicin Resistant Tuberculosis (RR-TB) Comparing a Short Course of Treatment (Containing Bedaquiline, Delamanid and Linezolid) With the Current South African Standard of Care

Start date: August 22, 2019
Phase: Phase 3
Study type: Interventional

BEAT Tuberculosis is a phase 3, open label, multi-centre, randomized controlled trial. The purpose of this trial is to compare the efficacy and safety of a Study Strategy consisting of 6 months of bedaquiline (BDQ), delamanid (DLM), and linezolid (LNZ), with levofloxacin (LVX) and clofazimine (CFZ) compared to the current South African Standard of Care (Control Strategy) for 9 months for the treatment of rifampicin resistant (RR-TB) Tuberculosis.